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Showing 20 of 27881 trials
Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function
NCT06078683
Recruiting
Conditions Type 2 Diabetes, Ketone Body Metabolism,...
Phase NA
Enrollment 30
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

This study is being done to evaluate how a ketone ester (KE) supplement affects heart function and health in people with diabetes compared to a placebo supplement (made with standard food ingredients that do not contain ketone esters).

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Crossover Primary purpose: Basic Science Masking/blinding: Triple

Interventions / Regimen

  • Dietary Supplement: Ketone Ester Acute — Participants will undertake a controlled feeding intervention where they will consume 25g of C8 Ketone Diester with a meal, and images obtained before and after consumption. The supplement powder contains 12.5 g C8 Diester, sodium caseinate and soluble corn fiber, per serving. The powder contains 120 kcal, 0 g fat, 3 g carbohydrate, and 0 g protein. A standardized meal will be provided to subjects to consume with their allocated supplement during the MRI visits. This meal is formulated with whole foods (i.e. chicken, rice, and a fruit bar) as a mix of macronutrients (29% protein, 3% fat, and 68% carbohydrate - not including the supplements). The meal consists of \~700kcal of food and will be standardized between all visits and subjects.
  • Dietary Supplement: Placebo Acute — Participants will undertake a controlled feeding intervention where they will drink two servings of the placebo with a meal, and images obtained before and after consumption. The placebo is flavor, energy, volume, and macronutrient matched will be given to patients as part of the placebo arm of the study. This placebo will not contain any BHB, which will be replaced with a similar caloric content of fat in the form of canola oil.

Primary Outcomes

  • Change in Cardiac MRI measures of cardiac function (Baseline, 2 weeks)
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-06-06
Completion: 2027-08-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Ohio State University
Principal Investigators:
  • Yuchi Han, MD, MMSc (PRINCIPAL_INVESTIGATOR) - Ohio State University
Contact Information
Study Contact:
Debbie Scandling, BS
614-688-5623
debbie.scandling@osumc.edu
Christopher Crabtree, MS
crabtree.223@osu.edu
Interventions
  • Dietary Supplement: Ketone Ester Acute — Participants will undertake a controlled feeding intervention where they will consume 25g of C8 Ketone Diester with a meal, and images obtained before and after consumption. The supplement powder contains 12.5 g C8 Diester, sodium caseinate and soluble corn fiber, per serving. The powder contains 120 kcal, 0 g fat, 3 g carbohydrate, and 0 g protein. A standardized meal will be provided to subjects to consume with their allocated supplement during the MRI visits. This meal is formulated with whole foods (i.e. chicken, rice, and a fruit bar) as a mix of macronutrients (29% protein, 3% fat, and 68% carbohydrate - not including the supplements). The meal consists of \~700kcal of food and will be standardized between all visits and subjects.
  • Dietary Supplement: Placebo Acute — Participants will undertake a controlled feeding intervention where they will drink two servings of the placebo with a meal, and images obtained before and after consumption. The placebo is flavor, energy, volume, and macronutrient matched will be given to patients as part of the placebo arm of the study. This placebo will not contain any BHB, which will be replaced with a similar caloric content of fat in the form of canola oil.
Study Locations (1 sites)
The Ross Heart Hospital, Columbus, Ohio 43210 United States
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years old and ≤ 80 years old 2. Type II Diabetes Mellitus 3. Stable medical therapy for at least 1 months as determined by the treating physician (no plan to change between the two testing sessions) 4. Dose of oral diuretics changes allowed, but must be stable for 1 week prior to randomization 5. Body Mass Index (BMI) ≥ 25 6. Ability to participate in exercise treadmill testing (only if CPET is performed) 7. Ability to sign written consent Exclusion Criteria: 1. Women who are pregnant, current breast-feeding, or have intention to become pregnant while in the trial 2. Known allergy or sensitivity to Gadolinium based contrast agents 3. Implanted pacemaker, cardioverter defibrillator, cardiac resynchronization therapy, left ventricular assist device 4. Other metallic implants/aneurysm clips that are contraindicated in MRI 5. Claustrophobia 6. History of severe kidney disease with eGFR\<30 ml/kg/1.73m2 7. Type I diabetes 8. History of diabetic ketoacidosis 9. Prior diagnosis of oxygen dependent pulmonary disease 10. Body Mass Index (BMI) \< 25 11. Major surgery (major according to the investigator's assessment) performed within 90 days prior to screening, or major scheduled elective surgery (e.g. hip replacement) within 90 days after screening 12. Acute or chronic liver disease, defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening 13. Gastrointestinal surgery or gastrointestinal disorder that might interfere with supplement consumption. Prior bariatric surgery allowed if weight-stable for past 3 months. 14. Any documented active or suspected malignancy or history of malignancy within 2 years prior to screening, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix, or low-risk prostate cancer (subjects with pre-treatment prostate-specific antigen levels of \<10 ng/mL, and biopsy Gleason scores of ≤6 and clinical stage T1c or T2a) 15. Presence of any disease other than diabetes that results in a life expectancy of \<1 year (in the opinion of the investigator) 16. Current enrolment in another investigational device or drug study or completion within \<30 days of a trial of another investigational device or drug study. 17. Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, will make the subject unlikely to fulfil the trial requirements or complete the trial 18. Any other clinical condition that might jeopardize subject safety during participation in this trial or prevent the subject from adhering to the trial Protocol. 19. Unable or unwilling to follow guidelines of assigned supplement group. 20. Allergy to test article ingredients, or lactose intolerance 21. The subject cannot currently be on a low-carb diet plan. 30-day washout would be required. 22. Refusal to consent
BioDulse II: The Effect of an Irish Seaweed Protein Extract on Glucose Control in Adults With Type 2 Diabetes
NCT05986253
Active, positions filled
Conditions Type 2 Diabetes
Phase NA
Enrollment 10
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

Co-ingesting protein with carbohydrate is an effective way to improve postprandial glucose handling. The investigators have isolated and identified a bioactive protein extracted from seaweed. The investigators aim to explore how varying doses of seaweed protein influence postprandial glycaemia and insulinaemia in a population with type 2 diabetes.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Crossover Primary purpose: Basic Science Masking/blinding: Single

Interventions / Regimen

  • Dietary Supplement: Seaweed protein — Novel protein extracted from seaweed
  • Dietary Supplement: Maltodextrin — maltodextrin solution

Primary Outcomes

  • Postprandial blood glucose area under the curve (AUC) (120 minutes)
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2023-08-07
Completion: 2031-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 10 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Limerick
Principal Investigators:
  • Brian Carson, PhD (PRINCIPAL_INVESTIGATOR) - University of Limerick
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Dietary Supplement: Seaweed protein — Novel protein extracted from seaweed
  • Dietary Supplement: Maltodextrin — maltodextrin solution
Study Locations (1 sites)
University of Limerick, Limerick, V94 T9PX Ireland
Eligibility Criteria
Inclusion Criteria: * Aged 18-67 Exclusion Criteria: * Terminal disease * Exclusively receiving enteral or parenteral nutrition * Any conditions/anomalies that are contraindications to bioelectrical impedance analysis as per institutional risk assessment and standard operating procedures * Past medical history of cancer, neurological, kidney, pulmonary, digestive (Coeliac disease), thyroidal disease, cognitive impairment
Assessing Gut Microbiome Changes Before and After an Oral Nutritional Supplement Intake Using the SIMBA Capsule in Diabetic Participants
NCT06704022
Not yet recruiting
Conditions Type 2 Diabetes
Phase PHASE1
Enrollment 30
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

This is a single-arm interventional clinical study, the primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of in diabetic participants from baseline to midpoint and endpoint in response to the ONS intervention. The study population is Type 2 Diabetes (T2D) participants (n=30) who will ingest an Oral Nutritional Supplement (ONS) .

Design

Study type: Interventional Phases: Phase1 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Dietary Supplement: Oral nutritional supplement — Consumption of the oral nutritional supplement

Primary Outcomes

  • Primary Outcome (Compared at intervention from baseline, midpoint, to endpoint (completion), an average of 6 weeks)
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Not yet recruiting
Start Date: 2025-09
Completion: 2026-08
Eligibility
Age: 40 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Nimble Science Ltd.
Collaborators: Alberta Obesity Centre
Contact Information
Study Contact:
Gwen Duytschaever, PhD
8664934633
clinical@nimblesci.com
Isaac Wong, MBT
8664934633
clinical@nimblesci.com
Interventions
  • Dietary Supplement: Oral nutritional supplement — Consumption of the oral nutritional supplement
Study Locations (1 sites)
Nimble Science, Calgary, Alberta T2L 1Y8 Canada
Eligibility Criteria
Inclusion Criteria: 1. Aged 40-65 years old at the inclusion of the study, both female and male subjects. 2. Has type 2 diabetes as evidenced by their medical history charts and is able to maintain number of medications, type and dose throughout the duration of the study. 3. Has HbA1c ≥ 6.5% and ≤ 9.5% based on a blood sample collected at the Screening Visit, documented within the past month or referred by a medical doctor. 4. Normal to overweight (BMI 20-29.9). 5. Weight is stable (has maintained current body weight within 3 kg) for the two months prior to the Baseline Visit. 6. Is taking a maximum of 3 oral anti-diabetic drugs, one of which must be Metformin. Other class of medications permitted include: Sulfonylurea, SGLT2 inhibitors, and DPP4 inhibitors. 7. Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the Baseline Visit. 8. Willingness to follow the protocol as described, including consumption of study product per the protocol and completing any forms/questionnaires needed throughout the study. 9. The participant is willing to refrain from taking non-study diabetes-specific oral nutritional formulas over the entire course of the study. 10. Willing to maintain their diet and physical activity levels during the study. 11. Able to swallow a 25mm length and 9mm width sized capsule. 12. At least a four-week washout period between the completion of a previous research study that required ingestion of any study food or drug and their start in the current study. Signed Informed Consent; willing and able to comply with study procedures Exclusion Criteria: 1. Confirmed type 1 diabetes and/or had a history of diabetic ketoacidosis. 2. Use of exogenous insulin or GLP1 agonists for glucose control. 3. Using diabetes-specific oral nutritional supplements(s), (e.g. Glucerna®, Boost etc.) defined as more than one eating occasion per week within the past 4 weeks (those users who can stop using such products for ≥4 weeks before baseline visit need not be excluded). 4. Follows a non-typical eating pattern such as very low carbohydrate diet (e.g., Adkins diet, ketogenic diet, high protein diet). 5. Has eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures in the opinion of the investigators. 6. Galactosemia and lactose intolerance 7. A chronic disease which in the opinion of the investigator, would adversely affect study safety or outcome. Such as, but not limited to * A significant cardiovascular event within 6 months prior to study entry or history of congestive heart failure, per physician evaluation. * End-stage organ failure (such as end-stage renal disease) or is post-organ transplant. * Current or history of renal disease or on dialysis or severe gastroparesis. * Current diagnosed hepatic disease such as liver cirrhosis or late-stage liver fibrosis. Participants with prevalent angina will not be excluded. 8. A chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis C, or HIV. 9. Subject has current active malignant disease or was treated within the last 6 months for cancer, except basal or squamous cell skin carcinoma, prior to enrollment. 10. Taking any herbals, dietary supplements, or medications during the past four weeks prior to baseline visit that could profoundly affect (in the opinion of the principal investigator or site physician) blood glucose, body weight, muscle, metabolism, appetite or microbiome (e.g. orlistat, contrave) (naltrexone/bupropion), Qsymia (phentermine/topiramate), Belviq (lorcaserin), incretin mimetics, other drugs indicated for weight loss, cannabis, glucocorticoids, prebiotics and probiotic supplements). Those users who have stopped using such supplements/ medications for ≥4 weeks prior to baseline need not be excluded). 11. Use of any medications in the week prior to the screening study visit, unless part of regular treatment, that could substantially alter gastrointestinal motor function (e.g., opioids, anticholinergics, GLP-1 analogues); laxative use is allowed if it is kept unchanged in the week prior to the SIMBA capsule ingestion timepoints. Proton pump inhibitors (PPIs) are allowed provided a wash-out period of 48 hours is respected before swallowing the SIMBA capsules and PPI treatment is resumed only 4 hours thereafter. \- If willing prokinetic use can be discontinued for the study duration, with a washout period of 2 weeks 12. Antibiotic use (except for topical use) ≤ 12 weeks prior to screening. Potential participants may be eligible once a 12-week washout is completed. 13. Current infection (requiring medication and antibiotics), inpatient surgery or received systemic corticosteroid treatment \[except for inhaled (includes nasal), topical, and ophthalmic steroids\] in the last 3 months. 14. Prior gastrointestinal disease, surgery, or radiation treatment which, in the Investigator's opinion, would interfere with consumption or digestion or absorption of study product, lead to intestinal structuring or obstruction with a risk of capsule non-excretion, including, e.g., achalasia, eosinophilic esophagitis, cancer diagnosis or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable. \- Diagnosed with Crohn's disease, ulcerative colitis or celiac disease. 15. History of known structural gastrointestinal abnormalities such as structures or fistulas leading to mechanical obstruction. 16. Organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome. 17. History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration. 18. History of less than three (3) bowel movements per week. 13) Consumption of probiotic or prebiotic capsule supplements within 1 month prior to screening. Potential participants may be eligible once a 1-month washout is completed. 19. Any prior Fecal Microbiota Transplantation. 20. Colon cleanses/bowel prep for 2 weeks. 21. Clotting or bleeding disorders (the use of Plavix® or a similar anticoagulant drug with no reported difficulty during blood draws will be allowed as per physician's opinion). 22. Has blood or blood-related diseases (e.g. hemophilia, thalassemia, sickle cell disease, hereditary spherocytosis, glucose-6-phosphate dehydrogenase deficiency). 23. Received a blood transfusion within the last 3 weeks. 24. Allergic or intolerant to any ingredient found in the study products. 25. Habitually engages in strenuous exercise (e.g., high intensity aerobic exercise, including heavy physical labor), duration of 1 hour or longer, 3 or more times per week. Potential participants may be eligible to participate if their levels exercise are reduced. 26. Participant is actively enrolled in a weight loss program. 27. Are scheduled for an MRI at any time during the study. Potential participants may be eligible to participate once their MRI procedure is completed. 28. Pregnant or breastfeeding. 29. Planning to become pregnant.
The Use of Statin in Diabetic Patients Not Known to Have Atherosclerotic Cardiovascular Disease
NCT06676683
Not yet recruiting
Conditions Diabete Type 2
Phase Not Applicable
Enrollment 300
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

the use of Statin in diabetic patients and its correlation to the guidelines recommendation.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Drug: Usage of Statin in diabetic patients — The use of statin in diabetic patients not known to have Atherosclerotic cardiovascular disease in a low income community

Primary Outcomes

  • changes in lipid profile in response to treatment with statin in diabetc patients (12 Weeks)
Interested in this trial?
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Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2024-12-01
Completion: 2025-12-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sohag University
Contact Information
Study Contact:
Islam A Hassan, Master
00201033799510
islam_abdelaziz_post@med.sohag.edu.eg
Usama M Abdelaal, Professor
00201065962094
Interventions
  • Drug: Usage of Statin in diabetic patients — The use of statin in diabetic patients not known to have Atherosclerotic cardiovascular disease in a low income community
Study Locations (1 sites)
Sohag university hospital, Sohag, 82524 Egypt
Eligibility Criteria
Inclusion Criteria: * All diabetic \> 18 years. Exclusion Criteria: * Diabetic Patients with known to have Atherosclerotic cardiovascular disease.
Multicentric Approval Study Trans-Duodenal Barrier for Typ 2 Diabetes With Obesity
NCT07417683
Not yet recruiting
Conditions Typ 2 Diabetes, Obesity, Obesity Type 2 ...
Phase NA
Enrollment 126
Locations 8 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

Approval study Trans-Duodenal Barrier The goal of this clinical trial is to determin the safety and performance of the newly developed Trans-Duodenal Barrier in adult Tryp 2 diabetic and obese patients. The Trans-Duodenal Barrier is an endoscopic implant which can be placed to the gastric outlet and the upper small bowel by interventional endoscopy. It consists of a 60 cm long foil tube , a transpyloric shaft and and two ringlike balloons to fix it at the pylorus. It will be removed after 6 months via gastroscopy. The main questions it aims to answer are: * Does the Trans-Duodenal Barrier lower the HbA1c of the participants ? * How frequent are adverse side effects related to the device? * How much ist the excessive wight loss of treated patients ? * Show patients with Metabolic assiociated Hepatosteatitis (MASH) improvements in liver elasticity (elastography) ? Researchers implant the Trans-Duodenal Barrier to enclosed patients and follow up them till 4 weeks after explantation. Participants will: * Get the Trans-Duodenal Barrier as an implant for 6 moths * Visit the clinic 3 times in the implant period and once for explant. * Receive a telefon interview 4 weeks after explant

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Device: endoscopic implant — The implant will be placed under sedation with the help of an standard flexible gastroscope. It will be fixed by fluid injection into ringlike ballons and place the device at the gastric outlet. After 6 months it will be removed by punction and evacuation of the ballons and extraction with a standard endoscopy foreighn body grasper.

Primary Outcomes

  • Main Outcome Measure HbA1c reduction (Improvement in 6 Month device implant time)
  • Wight control (Outcome after 6 months device implant time)
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-03
Completion: 2028-04
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 126 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Trans-Duodenal Concepts GmbH
Collaborators: novineon CRO GmbH, VDI Technologiezentrum
Principal Investigators:
  • Christoph Reissfelder, MD Prof. (PRINCIPAL_INVESTIGATOR) - University of Heidelberg, Medical Center Mannheim, Surgical Department
Contact Information
Study Contact:
Georg Kähler, MD, Prof.
+491797347734
georg.kaehler@transduodenal.com
Sabrina Rohrer, PhD
+49707198979133
sabrina.rohrer@novineon.com
Interventions
  • Device: endoscopic implant — The implant will be placed under sedation with the help of an standard flexible gastroscope. It will be fixed by fluid injection into ringlike ballons and place the device at the gastric outlet. After 6 months it will be removed by punction and evacuation of the ballons and extraction with a standard endoscopy foreighn body grasper.
Study Locations (8 sites)
Universitätsmedizin Mannheim, Mannheim, Baden-Wurttemberg 68167 Germany
Sozialstiftung Bamberg, Bamberg, Bavaria 96049 Germany
Universitätsklinikum Würzburg, Würzburg, Bavaria 97080 Germany
Knappschaft Kliniken Universitätsklinikum Bochum GmbH Medizinische Klinik, Bochum, North Rhine-Westphalia 44892 Germany
Städtisches Klinikum Dresden, Dresden, Saxony 01067 Germany
University of Leipzig Medical Center, Department of Oncology, Gastroenterology, Hepatology and Pneumology, Leipzig, Saxony 04103 Germany
Klinikum St. Georg Leipzig, Leipzig, Saxony 04129 Germany
Charite Universitätmedizin Berlin CVK, Berlin, 13353 Germany
Eligibility Criteria
Inclusion Criteria: * Obese patients with type 2 diabetes mellitus, * Age ≥ 18 years, * The patient is able to understand the nature, significance, and scope of the clinical trial (MPDG §28), * The patient has been informed and all written consents from the patient are available. Exclusion Criteria: * The patient is mentally incapable of understanding the nature, objectives, or possible consequences of the clinical trial. * The patient is unwilling or unable to follow postoperative instructions. * The patient has been placed in an institution by court order or official order (MPDG §27). * The patient lives more than 100 km from the treatment site. * Pregnancy. * The patient is participating in another clinical trial in the field of diabetes management or metabolic syndrome.
Evaluate the Effect of Remote Exercise Intervention on Blood Glucose Control and Physical Fitness in T2DM Patients
NCT07676773
Recruiting
Conditions Diabete Type 2, Cardio Respiratory Fitne...
Phase NA
Enrollment 80
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

The intervention group received 12 weeks of continuous remote intervention combined with health education. The control group only received 12 weeks of continuous health education, and the content and frequency were the same as those of the management group. Both groups received instruction at the beginning of the intervention. The intervention group was given priority to continuous walking/running combined with aerobic exercise and swimming. Five to seven sessions per week for 45 minutes each session. Acclimatizations were performed at an intensity of 40%-49% reserve oxygen uptake (VO2R) from weeks 1 to 4, and exercise was performed at an intensity of 50%-59% VO2R from weeks 5 to 12. 5 minutes each of preparation and grooming activities (including joint movement and stretching) for each exercise. Combined with incremental load resistance exercise 2-3 times a week, 8 movements, 2-3 groups each time, repeated 8-10 times/group, with a 2-min rest between groups. The heart rate, RPE (12-13, "fairly easy" to "somewhat laborious") and exercise bracelet were used to monitor the intensity and amount of exercise. The exercise intervention was usually delivered 1-2 h after a meal. The daily medical supervision in the process of management implementation was carried out by trained sports managers through the doctor terminal of "exercise assistant" to collect and monitor the data of the study subjects.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Health Services Research Masking/blinding: None

Interventions / Regimen

  • Behavioral: Remote Exercise + Health Education — Participants in this arm receive a 12-week personalized remote exercise program based on the FITT-VP principle (Frequency: 5-7 days/week; Intensity: 40-59% VO₂R; Time: 45 min/session + 5-min warm-up/cool-down; Type: aerobic walking/jogging plus resistance training with elastic bands twice weekly). Exercise is monitored via wearable devices and a mobile APP , with feedback and adjustments by trained exercise managers. All participants also receive standard diabetes health education (same content and frequency as the control group).
  • Behavioral: Health Education — 12-week standard diabetes health education (medical knowledge, diet/exercise advice, complications, mental health) with same frequency/content as experimental group, but without remote exercise.

Primary Outcomes

  • Change in glycemic control (Baseline and 12 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-06-01
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 80 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sichuan Academy of Medical Sciences
Contact Information
Study Contact:
Wanjing Chen, MPH(Master of Public Health)
0086 13980605563
270746867@qq.com
Interventions
  • Behavioral: Remote Exercise + Health Education — Participants in this arm receive a 12-week personalized remote exercise program based on the FITT-VP principle (Frequency: 5-7 days/week; Intensity: 40-59% VO₂R; Time: 45 min/session + 5-min warm-up/cool-down; Type: aerobic walking/jogging plus resistance training with elastic bands twice weekly). Exercise is monitored via wearable devices and a mobile APP , with feedback and adjustments by trained exercise managers. All participants also receive standard diabetes health education (same content and frequency as the control group).
  • Behavioral: Health Education — 12-week standard diabetes health education (medical knowledge, diet/exercise advice, complications, mental health) with same frequency/content as experimental group, but without remote exercise.
Study Locations (1 sites)
Sichuan Provinvial People's HSichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital（ SAMS&SPPH，Affiliated Hospital of UESTC）ospital, Chengdu, Sichuan 610000 China
Eligibility Criteria
Inclusion Criteria: (1) Both gender, age from 40 to 69 years old. (2) Meeting the diagnostic criteria for type 2 diabetes in China. (3) HbA1c is within 6.5%-7 .0% and no medication is taken. (4) Newly diagnosed with diabetes or the duration of the disease is no more than 5 years. (5) Possessing general exercise capacity and no obvious diseases in the muscle and osteoarticular systems. (6) The exercise risk is evaluated as medium or low risk through the PAR-Q+ questionnaire. (7) No contraindications to exercise tests. (8) Willing to adopt intensifed lifestyle intervention and complete the entire research process. Exclusion Criteria: (1) T1DM patients, autoimmune diabetes and special types of diabetes, including hypercortisolism, growth hormone tumor, glucagonoma and some special types of diabetes caused by genetic factors; (2) pregnant or lactating women; (3) regular use of antidiabetic drugs or insulin in the past three months; (4) fasting blood glucose level \> 16.7 mmol/L; (5) recurrent hypoglycemia; (6) a history of acute diabetic complications, including diabetic ketoacidosis, hyperosmolar hyperglycemia, and lactic acidosis; (7) a history of severe chronic microvascular or macrovascular complications; (8) diseases that may be exacerbated by exercise or impair exercise efciency, such as uncontrolled hypertension, hyperthyroidism, osteoarthritis or hypokalemia; (9) unable to use smart phones or wearable smart devices independently; (10) communication or motor dysfunction; (11) Patients with severe chronic diseases could not participate in the study.
Postpartum Continuous Glucose Monitoring for Type 2 Diabetes Mellitus Risk Evaluation in Patients With Gestational Diabetes Mellitus: POSTPOD Trial
NCT07449039
Recruiting
Conditions Gestational Diabetes Mellitus in Pregnan...
Phase NA
Enrollment 50
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

This is a pilot study designed to evaluate the effectiveness of continuous glucose monitoring (CGM) within hours of delivery to predict long-term risk of Type 2 Diabetes Mellitus in patients diagnosed with gestational diabetes. Participants will be provided a CGM within 2 hours after delivery and wear the device for 24 hours. Participants will be instructed to peel off the device after 24 hours. Participants will also be asked to complete two surveys regarding their experience at 1-3 months postpartum and 12-14 months postpartum.

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Other Masking/blinding: None

Interventions / Regimen

  • Device: Continuous Glucose Monistor — Continuous glucose monitoring sensor that provides 24/7 detailed glycemic information. Participants will wear for 24 hours and then be instructed to peel off.

Primary Outcomes

  • Clinical Efficacy Associated with CGM use immediately postpartum as compared to the 2 hr Glucose tolerance test (24 hours postpartum and 1-3 months postpartum)
  • Clinical Efficacy Associated with CGM use immediately postpartum as compared to the HbA1c test postpartum (24 hours postpartum and 1-3 months postpartum)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-09-28
Completion: 2030-06
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of California, Los Angeles
Principal Investigators:
  • Christina Han, MD (PRINCIPAL_INVESTIGATOR) - University of California, Los Angeles
Contact Information
Study Contact:
Rujuta Sathe
310-794-8893
RSathe@mednet.ucla.edu
Dana Levin-Lopez, MPH
310-794-8893
dlevinlopez@mednet.ucla.edu
Interventions
  • Device: Continuous Glucose Monistor — Continuous glucose monitoring sensor that provides 24/7 detailed glycemic information. Participants will wear for 24 hours and then be instructed to peel off.
Study Locations (1 sites)
University of California, Los Angeles, Los Angeles, California 90095 United States
Eligibility Criteria
Inclusion Criteria: * Prenatal care at UCLA Health * Planning to deliver at UCLA Ronald Reagan or UCLA Santa Monica * Confirmed gestational diabetes diagnosis based on 2-step approach * Maternal age \>= 18 years Exclusion Criteria: * Pre-gestational diabetes (T1DM or T2DM) * Multifetal gestation * Intra-amniotic infection by clinical criteria * Postpartum hemorrhage * Maternal ICU admission * Known allergy to medical-grade adhesive * Presence of skin lesions at anticipated CGM application site * Scheduled postpartum non-sonographic imaging study (radiograph, magnetic resonance imaging (MRI), or computed tomography (CT) scan) during trial * Metformin use * Steroid use * Terbutaline use within 4 hours of delivery * Cystic fibrosis * MODY (mature onset of diabetes in the young)
Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)
NCT06260722
Active, positions filled
Conditions Diabetes Mellitus, Type 2
Phase PHASE3
Enrollment 1250
Locations 77 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits.

Design

Study type: Interventional Phases: Phase3 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Retatrutide — Administered SC.
  • Drug: Semaglutide — Administered SC.

Primary Outcomes

  • Change from Baseline in Hemoglobin A1c (HbA1c) (%) (Baseline, Week 80)
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Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Active, positions filled
Start Date: 2024-02-21
Completion: 2027-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 1250 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Eli Lilly and Company
Principal Investigators:
  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) (STUDY_DIRECTOR) - Eli Lilly and Company
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Retatrutide — Administered SC.
  • Drug: Semaglutide — Administered SC.
Study Locations (77 sites)
University of Alabama - Department of Nutrition Sciences, Birmingham, Alabama 35294 United States
Neighborhood Healthcare Institute of Health, Escondido, California 92025 United States
Long Beach Research Institute, Long Beach, California 90805 United States
Valley Clinical Trials, Inc., Northridge, California 91325 United States
Rancho Cucamonga Clinical Research, Rancho Cucamonga, California 91730 United States
University of Colorado Anschutz Medical Campus, Aurora, Colorado 80045 United States
Arrow Clinical Trials, Daytona Beach, Florida 32117 United States
New Age Medical Research Corporation, Miami, Florida 33186 United States
South Broward Research, Miramar, Florida 33027 United States
Clinical Research of Central Florida, Winter Haven, Florida 33880 United States
Eligibility Criteria
Inclusion Criteria: * Have Type 2 Diabetes (T2D) * Have HbA1c ≥ 7.0% (53 millimoles per mole (mmol/mol)) to ≤ 10.5% (91 mmol/mol) * Have been on a stable diabetes treatment consisting of metformin ≥ 1500 milligrams per day (mg/day) with or without SGLT2i during 90 days prior to screening * Are of stable weight for at least 90 days prior to screening * Have a Body Mass Index (BMI) ≥ 25.0 kilograms per meter squared (kg/m\^2) Exclusion Criteria: * Have Type 1 Diabetes (T1D) * Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening * Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema * Have an estimated glomerular filtration rate (eGFR) \<45 milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory * Have a prior or planned surgical treatment for obesity * Have New York Heart Association Functional Classification IV congestive heart failure * Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening * Have a known clinically significant gastric emptying abnormality * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years * Have any lifetime history of a suicide attempt * Had chronic or acute pancreatitis * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2 * Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening.
More Health Less Diabetes
NCT07079722
Recruiting
Conditions Pre-diabetes
Phase NA
Enrollment 90
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

The "More Health, Less Diabetes" project is a hybrid randomized controlled trial to prevent type 2 diabetes in individuals at risk through structured exercise and lifestyle education. While exercise benefits for people with diabetes are well-documented, evidence remains limited on the effectiveness and cost-effectiveness of in-person and home-based exercise programs in a prediabetic population. This study aims to understand the clinical and cost-effectiveness of a three-arm RCT (online, in-person, and a control group) in people at high risk of developing T2DM. This 12-month program includes six months of supervised exercise (3 times/week) and a six-month follow-up. During the first six months, both intervention groups will attend educational sessions to improve health literacy and promote healthy habits. The primary outcome will be 2h glycemia in an oral glucose tolerance test. Secondary outcomes include other aspects of glycemic control (HbA1c, fasting glycemia, HOMA-IR, Matsuda index), 24-hour movement, body composition, vascular health, physical fitness, and cost-effectiveness using a social return on investment approach.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Behavioral: Exercise — This project is a randomized controlled trial (RCT) with three distinct groups: a control group (CG), an online intervention group (OIG), and an in-person intervention group (IIG). The OIG will receive online educational sessions and structured home-based exercises, while the IIG will participate in in-person educational sessions and supervised physical exercise. The control group will not participate in educational sessions or structured physical exercise.

Primary Outcomes

  • 2-hour glucose tolerance test (OGTT) (1 year)
Interested in this trial?
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-09-01
Completion: 2026-12-20
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 90 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Faculdade de Motricidade Humana
Contact Information
Study Contact:
João Magalhães Associate Professor, Doctor
967 832 539
joaomagalhaes@fmh.ulisboa.pt
Interventions
  • Behavioral: Exercise — This project is a randomized controlled trial (RCT) with three distinct groups: a control group (CG), an online intervention group (OIG), and an in-person intervention group (IIG). The OIG will receive online educational sessions and structured home-based exercises, while the IIG will participate in in-person educational sessions and supervised physical exercise. The control group will not participate in educational sessions or structured physical exercise.
Study Locations (1 sites)
Faculty of Human Kinetics, Lisbon, Lisbon District 1499-002 Portugal
Eligibility Criteria
Inclusion Criteria: 1. High or Very High Risk according to the FINDRISC questionnaire; 2. Analytical confirmation of no diagnostic criteria for Diabetes, following a type 2 Diabetes risk assessment; 3. Committed to making lifestyle changes to manage diabetes; 4. Internet access; 5. Availability to participate in the program as required (schedule, location); Exclusion Criteria: 1. pregnancy (self-report/medical record); 2. Inability to use digital devices 3. Presence of abnormalities on exercise stress test.
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
NCT07361341
Recruiting
Conditions Type 2 Diabetes Mellitus (T2D)
Phase NA
Enrollment 25
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

The goal of this pilot intervention study is to learn if culturally appropriate food bundles and nutrition education can help people with diabetes who struggle to afford healthy food in patients with diabetes receiving care at Community Care Clinic in Winston-Salem, NC. The main questions we hope to answer are: 1. Can providing culturally appropriate foods and recipes improve how people cook and prepare meals at home? 2. Can this approach improve people's nutrition knowledge and help them better manage their diabetes? 3. Can this approach improve overall health outcomes for people with diabetes who face food insecurity? Participants will: 1. Complete an initial interview and survey about their food security, health challenges, and social needs 2. Receive culturally appropriate food bundles designed for their community 3. Receive easy-to-use educational materials including recipes and cooking guides that match their reading level 4. Complete follow-up surveys at 3 months and 6 months to track any changes in their cooking habits, nutrition knowledge, diabetes management, and health

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Supportive Care Masking/blinding: None

Interventions / Regimen

  • Other: Food Bundle Intervention — Culturally tailored food bundles containing Hispanic-friendly ingredients that support diabetes management, as well as recipe resources and cooking guides designed for various literacy levels.

Primary Outcomes

  • Hemoglobin A1c (Baseline)
  • Hemoglobin A1c (Month 3)
  • Hemoglobin A1c (Month 6)
  • Self-efficacy in diabetes management (Baseline)
  • Self-efficacy in diabetes management (Month 3)
  • Self-efficacy in diabetes management (Month 6)
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-04-01
Completion: 2026-10
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 25 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Wake Forest University Health Sciences
Principal Investigators:
  • Megan B Irby, PhD (PRINCIPAL_INVESTIGATOR) - Wake Forest University Health Sciences
Contact Information
Study Contact:
Megan B Irby, PhD
336.758.4642
irbym@wfu.edu
Interventions
  • Other: Food Bundle Intervention — Culturally tailored food bundles containing Hispanic-friendly ingredients that support diabetes management, as well as recipe resources and cooking guides designed for various literacy levels.
Study Locations (1 sites)
Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157 United States
Eligibility Criteria
Inclusion Criteria: * Adults aged ≥18 years at the time of the first clinic visit during the study period; regardless of sex, gender, race, or ethnicity * Active patients of the Community Care Clinic (CCC) who received at least one clinical encounter between January 1, 2024 and December 31, 2024; with at least one scheduled follow-up appointment during the prospective study period * Meet CCC's standard eligibility criteria: Uninsured status (no health insurance coverage); Family income ≤250% of the Federal Poverty Level; Resident of Forsyth County, North Carolina, or surrounding service area * Completed at least one validated food insecurity screening tool during the study period as part of routine clinical care * Medical record contains at least one documented measurement for any of the primary outcome variables (body mass index, blood pressure, HbA1c, or healthcare utilization metric) * Documented diagnosis of Type 2 diabetes (ICD-10: E11.x) OR; Pre-diabetes diagnosis (ICD-10: R73.03) with a hemoglobin A1c ≥9.5% * Reside within designated pickup/delivery zones for food bundle distribution (primary zip codes: 27101, 27105, 27107, and adjacent service areas) * Able and willing to provide written informed consent (available in English and Spanish) * Able to participate in baseline and follow-up assessments either in English or Spanish (the two primary languages at CCC) Exclusion Criteria: * Unable to speak proficiently in English or Spanish, as this study and the CCC staff are equipped only to provide services in English and Spanish languages. * Have known food allergies (documented in the electronic medical record and/or self-reported to CCC or study staff) that may preclude participation in the food bundle program inherent to this protocol. * Have incomplete records. Medical charts with missing or incomplete demographic information (age, gender) that cannot be verified through other sources * Patients who were pregnant at any point during the study period (due to expected physiological changes in weight, blood pressure, and glucose metabolism that would confound outcome measurements) * Patients with documented terminal illness or hospice care during the study period, as their health trajectory and care priorities differ fundamentally from the general population * Transient patients. Patients who received only one-time urgent/emergent care without established continuity of care at CCC (defined as \<2 visits during study period) * Type 1 diabetes (ICD-10: E10.x) - requires different dietary management; End-stage renal disease requiring dialysis (special dietary restrictions); Active eating disorder diagnosis; Severe food allergies that would limit ability to safely consume food bundle contents; Recent bariatric surgery (\<12 months) * Documented cognitive impairment or intellectual disability that would impair ability to provide informed consent or participate meaningfully in intervention without caregiver support * Currently enrolled in other intensive nutrition intervention studies or food prescription programs that would confound assessment of the intervention's independent effects * Primary language other than English or Spanish * Plans to move outside of CCC's service area or discontinue care at CCC within the 6-month study period * Physical disabilities, literacy barriers, or other factors that would prevent completion of baseline or follow-up survey instruments, unless accommodations can be reasonably made
Personalized Hypoglycemia Outpatient Treatment - a Feasibility Study
NCT07094529
Recruiting
Conditions Type 2 Diabetes (T2DM), Hypoglycemia (Di...
Phase NA
Enrollment 120
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

This study will offer two study interventions designed to bring on a mild low blood sugar (capillary blood glucose result 3.0 to 3.8 mmol/L), in order to study the effectiveness of each study participant's personal choice of treatment and first recheck time. The two study interventions that the participant can choose to complete (one or both interventions). Based on each participant's own experience with hypoglycemia treatment or their preferences, the participant can choose one of 4 simple carbohydrate treatment quantities, and choose one of 4 capillary blood glucose recheck times.

Design

Study type: Interventional Phases: Allocation: Non Randomized Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Behavioral: Recumbent Exercise Bike to induce mild hypoglycemia — The participant rides the recumbent exercise bike at their preferred speed and records the distance travelled until there is onset of mild hypoglycemia, determined by capillary blood glucose test result 3.0 to 3.8 mmmol/L. Based on each participant's own experience with hypoglycemia treatment or their preferences, the participant can choose one of 4 simple carbohydrate treatment quantities: 8 grams, 16 grams, 20 grams, 32 grams The participant can choose one of 4 capillary blood glucose recheck times: 15 minutes, 20 minutes, 25 minutes, 30 minutes.
  • Behavioral: Delaying food to induce mild hypoglycemia, — At the study visit, in front of the study nurse, the participant takes their usual clinical care dose of sulfonylurea or basal insulin. If the participant's usual clinical care includes insulin with a rapid-acting component, then its dose is reduced based on the study protocol. No food intake (water is allowed) until there is onset of mild hypoglycemia, determined by a capillary blood glucose test result 3.0 to 3.8 mmol/L. Based on each participant's own experience with hypoglycemia treatment or their preferences, the participant can choose one of 4 simple carbohydrate treatment quantities: 8 grams, 16 grams, 20 grams, 32 grams The participant can choose one of 4 capillary blood glucose recheck times: 15 minutes, 20 minutes, 25 minutes, 30 minutes.

Primary Outcomes

  • To determine feasibility to recruit an average of 8 patients per month at the study site (The Ottawa Hospital Diabetes clinics) for study protocol performance. (12 months)
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-07-21
Completion: 2027-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Ottawa Hospital Research Institute
Principal Investigators:
  • Cathy Sun, MD MSc (PRINCIPAL_INVESTIGATOR) - Ottawa Hospital Research Institute
Contact Information
Study Contact:
Cathy Sun, MD MSc
613-738-8333
csun@toh.ca
Interventions
  • Behavioral: Recumbent Exercise Bike to induce mild hypoglycemia — The participant rides the recumbent exercise bike at their preferred speed and records the distance travelled until there is onset of mild hypoglycemia, determined by capillary blood glucose test result 3.0 to 3.8 mmmol/L. Based on each participant's own experience with hypoglycemia treatment or their preferences, the participant can choose one of 4 simple carbohydrate treatment quantities: 8 grams, 16 grams, 20 grams, 32 grams The participant can choose one of 4 capillary blood glucose recheck times: 15 minutes, 20 minutes, 25 minutes, 30 minutes.
  • Behavioral: Delaying food to induce mild hypoglycemia, — At the study visit, in front of the study nurse, the participant takes their usual clinical care dose of sulfonylurea or basal insulin. If the participant's usual clinical care includes insulin with a rapid-acting component, then its dose is reduced based on the study protocol. No food intake (water is allowed) until there is onset of mild hypoglycemia, determined by a capillary blood glucose test result 3.0 to 3.8 mmol/L. Based on each participant's own experience with hypoglycemia treatment or their preferences, the participant can choose one of 4 simple carbohydrate treatment quantities: 8 grams, 16 grams, 20 grams, 32 grams The participant can choose one of 4 capillary blood glucose recheck times: 15 minutes, 20 minutes, 25 minutes, 30 minutes.
Study Locations (1 sites)
The Ottawa Hospital, Ottawa, Ontario K1H 7W9 Canada
Eligibility Criteria
Inclusion Criteria: * In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Consent provided 2. Age \>= 18 years. 3. Diagnosed as type 2 diabetes mellitus. 4. Type 2 diabetes medications include at least one of the following for at least one month prior to entering the study: sulfonylurea or insulin of any type. Exclusion Criteria: * An individual who meets any of the following criteria will be excluded from participation in this study: 1. Diagnosed as another form of diabetes mellitus. 2. Has a history of hypoglycemia unawareness. 3. Had a hypoglycemia event, defined as capillary blood glucose \< 3.9 mmol/L within 24 hours prior to the study visit booking time.
Recurrent Hypoglycemia in Type 1 Diabetes (Aim 2)
NCT04387422
Active, positions filled
Conditions Diabetes Mellitus, Type 1
Phase NA
Enrollment 50
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

This study will explore the cerebral mechanisms of impaired awareness of hypoglycemia (IAH) in type 1 diabetics following exposure to experimental recurrent hypoglycemia (HG). To induce IAH, patients with T1D identified to have normal awareness of hypoglycemia (NAH) will undergo three 2-hour long hypoglycemic clamps. Neurochemical profiles will be measured by high field MRS before and after induction of IAH. Subject glycemic variability and activity/sleep for 1 week before each study will be monitored as all factors have been shown to alter responses to HG.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Basic Science Masking/blinding: None

Interventions / Regimen

  • Other: Experimental hyperglycemia — Experimental hyperglycemia with MRI

Primary Outcomes

  • Glucose kinetics during hyperglycemic clamps before and after induction of IAH (240 Minutes)
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2020-08-12
Completion: 2028-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Minnesota
Principal Investigators:
  • Elizabeth R Seaquist, MD (PRINCIPAL_INVESTIGATOR) - University of Minnesota
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Other: Experimental hyperglycemia — Experimental hyperglycemia with MRI
Study Locations (1 sites)
University of Minnesota, Minneapolis, Minnesota 55455 United States
Eligibility Criteria
Inclusion Criteria: * Type 1 diabetes diagnosed on clinical or laboratory grounds * Diabetes duration 2 - 30 years * Hemoglobin A1C \<8.5% Exclusion Criteria: * Impaired awareness of hypoglycemia as determined by the Cox and Gold questionnaires * Pregnant or plan to become pregnant during the study period * Uncontrolled hypertension (blood pressure \> 145/95 mmHg at screening) * Evidence of autonomic neuropathy (presence of orthostatic hypotension or history of gastroparesis) * Proliferative retinopathy * Impaired kidney function (GFR \< 45) * History of myocardial infarction, stroke, seizures, neurosurgical procedures, major depression requiring hospitalization within the last 5 years, arrhythmias * Current substance abuse * Use of drugs that can alter glucose metabolism including but not limited to glucocorticoids and niacin, and excluding insulin and glucose lowering drugs used to treat diabetes, as determined by a clinician * Inability to undergo MRI scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs * Unable to complete all study visits or procedures, as determined by the investigator
China Diabetes Registry by Metabolic Management Center
NCT03811470
Recruiting
Conditions Type 2 Diabetes Mellitus, Type1 Diabetes...
Phase Not Applicable
Enrollment 1000000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

Epidemiologic studies have revealed a tremendous increase in the prevalence of diabetes and related mortality worldwide. In order to meet all the challenges in the treatment of metabolic diseases in China, the National Metabolic Management Center (MMC) was founded in 2016. The objective of the MMC is to launch a new metabolic disease management model based on the Internet health information platform. It allows the application and evaluation of diabetes treatment strategies at these centers. The proprietary electronic medical database in the MMC will help the dynamic big-data analysis in diabetes epidemiology, prevention, diagnosis, and treatment. It will also provide prospective data support including economic evaluation in management of chronic diseases for the Healthy China 2030 strategy. Objective 1. The purpose of the present study is to establish a multi-center nationwide prospective database of diabetes patients in MMCs, including clinical data, biological samples library so as to explore the epidemiology, genetics, new biomarkers, risk factors, and prognostic methods related to diabetes and its complications, as well as other metabolic diseases. 2. To collect cross-sectional data from patients seen and treated at each MMC centers so as to evaluate: the current status of care of patients with diabetes and its related complications, as well as other risk factors treatment strategies at these centers. Patients'costs and quality of life (QoL) will also be evaluated. 3. To collect the prospective data of patients treated at each MMC centers in order to evaluate the strategies for the achievement of treatment goals, changes in management, control of risk factors, incidence and progression of all-diabetes related clinical endpoints (including mortality), behavioral changes, psychological well being as well as costs and QoL.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Other: Standard diabetes management model in each MMC center — Standard diabetes management model in each MMC center

Primary Outcomes

  • Incidence of all diabetes-related clinical endpoints; including: 1. Macrovascular morbidity (through study completion, up to 20 years)
  • Microvascular morbidity (through study completion, up to 20 years)
  • Mortality (through study completion, up to 20 years)
  • Major infections - pulmonary and non-pulmonary requiring hospitalizations (through study completion, up to 20 years)
  • Heart failure (through study completion, up to 20 years)
  • Neuropathy (through study completion, up to 20 years)
  • All cancers (through study completion, up to 20 years)
Interested in this trial?
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Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2017-05-31
Completion: 2039-05-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 1000000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Guang Ning
Contact Information
Study Contact:
Guang Ning, MD,PHD
008621-64370045
gning@sibs.ac.cn
Interventions
  • Other: Standard diabetes management model in each MMC center — Standard diabetes management model in each MMC center
Study Locations (1 sites)
National Metabolic Management center, Multiple Locations, China
Eligibility Criteria
Main Inclusion Criteria: * Age ≥ 18 years old * Diagnosis of diabetes mellitus based on self-reported history of diagnosed diabetes by clinicians or in line with the current domestic diagnostic criteria for diabetes * Gender: males and females * Provide written informed consent * Satisfactory compliance Main Exclusion Criteria: * Patients with significantly reduced life expectancy (less than 5 years) * With Drug abuse * With AIDS or syphilis or infectious diseases such as viral hepatitis or tuberculosis in active phase at enrollment
Effect of Ajwa Seed Powder on HbA1c and Body Composition in Overweight and Obese Patients With Type 2 Diabetes Mellitus
NCT07702097
Not yet recruiting
Conditions Obesity & Overweight, Type 2 Diabetes (T...
Phase NA
Enrollment 30
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

The goal of this interventional study (clinical trial) is to check if ajwa seed powder can treat type 2 diabetes mellitus in overweight and and obese patients with type 2 diabetes mellitus including both male and female of the age group between 30-50. The main question is what would be the impact of ajwa seed powder on HbA1c and body composition in overweight and obese patients with type 2 diabetes mellitus which aim to result in better glycemic control particular Hba1c, and body composition improvement in type 2 diabetes mellitus patients Participants will be asked to consume 4 grams of ajwa seed powder per day

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Other Masking/blinding: None

Interventions / Regimen

  • Dietary Supplement: Ajwa Seed powder — The intervention in this study is Ajwa (Phoenix dactylifera) seed powder, a natural plant-based product obtained from Ajwa dates. It is distinguished from other clinical interventions by its botanical origin, absence of chemical modification, and standardized preparation process, which includes cleaning, drying, and grinding into a uniform powder form. A fixed dose is administered to all participants in the intervention arm according to the study protocol. Unlike pharmaceutical or biologic interventions, it is a non-pharmacological dietary supplement intended for metabolic support. The intervention specifically targets HbA1c levels and body composition in diabetic and/or obese individuals, with no additional experimental treatments included. This controlled and standardized approach differentiates it from other clinical or nutritional interventions.

Primary Outcomes

  • change in HbA1c concentration (%) from baseline to week 12 in 30 overweight and obese patients with type 2 diabetes mellitus (12 weeks)
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Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-06
Completion: 2027-06
Eligibility
Age: 30 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Veterinary and Animal Sciences, Lahore - Pakistan
Principal Investigators:
  • Dr. Waqas Ahmad (PRINCIPAL_INVESTIGATOR) - UVAS
Contact Information
Study Contact:
Nimrah Tahir, Mphil food and nutrition
+923314568232
nimrahtahir1999@gmail.com
Dr. Waqas Ahmad
+92 333 5950108
waqas.niaz@uvas.edu.pk
Interventions
  • Dietary Supplement: Ajwa Seed powder — The intervention in this study is Ajwa (Phoenix dactylifera) seed powder, a natural plant-based product obtained from Ajwa dates. It is distinguished from other clinical interventions by its botanical origin, absence of chemical modification, and standardized preparation process, which includes cleaning, drying, and grinding into a uniform powder form. A fixed dose is administered to all participants in the intervention arm according to the study protocol. Unlike pharmaceutical or biologic interventions, it is a non-pharmacological dietary supplement intended for metabolic support. The intervention specifically targets HbA1c levels and body composition in diabetic and/or obese individuals, with no additional experimental treatments included. This controlled and standardized approach differentiates it from other clinical or nutritional interventions.
Study Locations (1 sites)
Sultan Hospital, Sheikhupura, 39359 Pakistan
Eligibility Criteria
Inclusion Criteria * Age: 30-50 years * Gender: Male/female * Body Mass Index (BMI): 25-35 kg/m² * Type 2 diabetes mellitus: HbA1c ≥ 6.5% Exclusion criteria History of alcoholic liver disease or cirrhosis; liver dysfunction based on initial blood tests * Patients being treated with insulin * High initial levels of serum creatinine (men\>1.5 mg/dl; women\>1.2 mg/dl) * Pregnant/lactating females or women who cannot take proper contraceptive measures * Symptoms consistent with peptic ulcer disease or history of peptic ulcers * Active cancer patients * Severe non-diabetes-related illnesses * Patients with heart, liver, or lung failures * Patients with blood disorders or on anticoagulant drugs such as warfarin Any other disease as decided by the principal investigator, which might put the safety of the subjects at risk while conducting the test
Continuous Glucose Monitor Use in Pregnancy
NCT05317585
Recruiting
Conditions Type 2 Diabetes Treated With Insulin, Pr...
Phase NA
Enrollment 180
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study is to perform a randomized controlled trial among 180 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Prevention Masking/blinding: None

Interventions / Regimen

  • Device: Continuous Glucose Monitor — Continuous Glucose Monitor
  • Device: Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose) — Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

Primary Outcomes

  • Large for Gestational Age Infant (Within 2 hours of birth)
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-05-23
Completion: 2027-07-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 180 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Massachusetts, Worcester
Principal Investigators:
  • Gianna L Wilkie, MD (PRINCIPAL_INVESTIGATOR) - University of Massachusetts, Worcester
Contact Information
Study Contact:
Gianna L Wilkie, MD
7743642523
Gianna.Wilkie@umassmemorial.org
Heidi Leftwich, DO
Heidi.Leftwich@umassmemorial.org
Interventions
  • Device: Continuous Glucose Monitor — Continuous Glucose Monitor
  • Device: Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose) — Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)
Study Locations (1 sites)
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts 01605 United States
Eligibility Criteria
Inclusion Criteria: Women will be deemed eligible for the study by the following inclusion criteria: * 1\) age greater than or equal to 18 years old * 2\) singleton gestation less than or equal to 14 weeks at initial obstetric visit * 3\) established diagnosis of T2DM by laboratory criteria including hemoglobin A1c ≥6.5%, oral glucose tolerance test ≥200 mg/dL, or fasting plasma glucose ≥126 mg/dL * 4\) receiving prenatal care at UMASS Memorial Health Care (UMMHC) and plans to deliver at UMMHC * 5\) able and willing to provide informed consent Exclusion Criteria: Women will be deemed ineligible for the study based on the following exclusion criteria: * 1\) known diagnosis of type 1 diabetes or gestational diabetes * 2\) plan to receive prenatal care or delivery outside of UMMHC * 3\) inability to provide informed consent * 4\) multifetal gestation
Voice-activated and Touchscreen-controlled Smart Speaker Intervention for Older Adults With Poorly Controlled Type 2 Diabetes
NCT07734259
Not yet recruiting
Conditions Diabetes, Diabetes (DM), Type 2 Diabetes
Phase NA
Enrollment 30
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

This is a pre-post pilot study that will test the feasibility and acceptability of a health educator delivered diabetes education and skills training intervention using a voice-activated, touch screen controlled, smart speaker. We will enroll 30 adults aged 50 and older with poorly controlled type 2 diabetes as defined by a hemoglobin A1C of 8% in the study.

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Health Services Research Masking/blinding: None

Interventions / Regimen

  • Behavioral: VATC-SS Intervention — Individuals in the VATC-SS intervention will receive weekly diabetes education and skills training calls for 12 weeks from a health educator through the voice-activated, touch screen controlled smart speaker.

Primary Outcomes

  • HemoglobinA1C (Baseline and 3-months post enrollment)
  • Blood Pressure (Baseline and 3-months post-enrollment)
  • Low-Density Lipoprotein Cholesterol (Baseline and 3-months post-enrollment)
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-09-01
Completion: 2028-03-30
Eligibility
Age: 50 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Medical College of Wisconsin
Contact Information
Study Contact:
Aprill Z Dawson, PhD, MPH
414-955-8828
adawson@mcw.edu
Interventions
  • Behavioral: VATC-SS Intervention — Individuals in the VATC-SS intervention will receive weekly diabetes education and skills training calls for 12 weeks from a health educator through the voice-activated, touch screen controlled smart speaker.
Eligibility Criteria
Inclusion Criteria: * 1\) Aged 50 and older; 2) clinical diagnosis of poorly controlled type 2 diabetes, defined as HbA1C greater than or equal to 8% at the screening visit; 3) willing to install and use the VATC-SS for the 3 months of the study. Exclusion Criteria: * 1\) Mental confusion at screening assessment suggesting significant dementia; 2) alcohol or drug abuse/dependency at screening assessment; 3) active psychosis or acute mental disorder at screening assessment.
Improving Diabetes Care With Strategies For Addressing Health-Related Social Needs and Community Partnerships
NCT07043426
Recruiting
Conditions Diabetes Mellitus, Type 2
Phase NA
Enrollment 900
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

The goal of this study is to develop, implement, and evaluate a patient-centered triage and referral model designed to improve health outcomes for individuals with uncontrolled type 2 diabetes mellitus (T2DM) and unmet health-related social needs. The intervention builds on the existing THRIVE infrastructure at Boston Medical Center (BMC), which includes screening for social needs and a resource referral guide. It integrates medical and social care by embedding a data-driven triage tool within the EPIC electronic health record system, engaging community health workers trained in population health, and initiating closed-loop EPIC integrated referrals to community-based organizations. This study will use a hybrid type 3 effectiveness-implementation trial design to evaluate the implementation of the THRIVE-DM intervention at the clinic level. Preliminary effectiveness will be assessed by comparing THRIVE-DM to usual care in its ability to increase patient connections to community-based organizations and improve clinical outcomes. Using a stratified randomization approach, the investigators will compare referral closure rates, receipt of social services, hemoglobin A1C levels, and patterns of health service utilization between patients enrolled in THRIVE-DM and those receiving standard care

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Health Services Research Masking/blinding: None

Interventions / Regimen

  • Other: THRIVE-DM — Low-SS and High-SS will be referred by the CHW to appropriate community-based organizations through the THRIVE Directory. High-SS participants will also receive additional support from a patient navigator (PN), who will follow up to facilitate service connection and address barriers to engagement. CHWs and PNs will coordinate care to ensure services are aligned with the patient's assessed needs.
  • Other: Standard of care — Standard of care may include support from the primary care team, health related social needs (HRSN) screening via the THRIVE screener, printed resource guides, and referrals to community-based organizations initiated at the discretion of clinic staff using the THRIVE Directory.

Primary Outcomes

  • Number of participants that connect to Community-Based Organizations (3 months, 6 months, 3 months post intervention)
  • Number of participants that are helped by Community-Based Organizations (3 months, 6 months, 12 months post intervention)
  • Changes in HbA1c (3 months, 6 months, 12 months post intervention)
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-12-26
Completion: 2027-04
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 900 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Boston Medical Center
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigators:
  • Michael Fischer, MD (PRINCIPAL_INVESTIGATOR) - Boston Medical Center, Internal Medicine
Contact Information
Study Contact:
Michael Fischer, MD
617-414-7288
Michael.Fischer@bmc.org
Uma Khemraj, MS
617-414-7288
Uma.Khemraj@bmc.org
Interventions
  • Other: THRIVE-DM — Low-SS and High-SS will be referred by the CHW to appropriate community-based organizations through the THRIVE Directory. High-SS participants will also receive additional support from a patient navigator (PN), who will follow up to facilitate service connection and address barriers to engagement. CHWs and PNs will coordinate care to ensure services are aligned with the patient's assessed needs.
  • Other: Standard of care — Standard of care may include support from the primary care team, health related social needs (HRSN) screening via the THRIVE screener, printed resource guides, and referrals to community-based organizations initiated at the discretion of clinic staff using the THRIVE Directory.
Study Locations (1 sites)
Boston Medical Center, Boston, Massachusetts 02118 United States
Eligibility Criteria
Inclusion Criteria: * Diagnosis: Must have a diagnosis of Type 2 Diabetes Mellitus (T2DM), confirmed by a current diagnosis in the medical record or at least two billing codes in the last two years, or an HbA1c level ≥6.5% in the last two years. * Uncontrolled T2DM: Must have an HbA1c ≥9% at the time of screening. * Health-Related Social Needs: Must have been screened for health related social needs (HRSNs) during a General Internal Medicine (GIM) visit in the last 3 months and screened positive for at least one HRSN. Exclusion Criteria: * Patients enrolled in Complex Care Management (CCM). * Patients receiving hospice care. * Patients who are deceased * Patients with Type 1 Diabetes Mellitus (T1DM).
The Transit Bipartition With the Use of a Metallic Anastomosis Clip and Circular Fundocorporeal Gastroplication
NCT07495020
Recruiting
Conditions Type 2 Diabetes Mellitus (T2DM), Obesity...
Phase NA
Enrollment 90
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

This study evaluates a new surgical device - the Metallic Anastomotic Clip (MAC) - for performing a laparoscopic bypass gastroenteroanastomosis with entero-enteric anastomosis (transit bipartition / "dual-path" procedure) in patients with type 2 diabetes mellitus (T2DM) who have overweight or Class I obesity (BMI 25-34.9 kg/m²). Currently, most bariatric and metabolic surgery procedures are only approved for patients with a BMI above 35 kg/m². However, many T2DM patients have BMI less 34.9 kg/m2 and cannot access surgical treatment under existing national guidelines. The transit bipartition procedure addresses this gap by creating a second food pathway from the stomach to the ileum while preserving normal duodenal digestion - producing a strong incretin (GLP-1) effect similar to GLP-1 receptor agonists (e.g., semaglutide), without causing excessive weight loss or requiring lifelong vitamin supplementation. The MAC is a novel compression anastomotic device designed to replace conventional hand-sewn or stapled anastomoses, potentially reducing complications such as anastomotic leak, bleeding, marginal ulcers, and strictures, while also lowering operative costs. Participants will be randomised into three groups. The study will assess metabolic outcomes (T2DM remission, glycaemic control), surgical safety, quality of life, and cost-effectiveness over a follow-up period of 2026-2027.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Procedure: Laparoscopic transit bipartition with Metallic Anastomotic Clip and Circular Fundocorporeal Gastroplication — The procedure begans creation circular fundocorporeal gastroplication without gastrectomy. A gastroplication calibrated over a 36F calibration tube using two layer nonabsorbable suture. The mobilisation of great curvature starts 4 cm above the pylorus and gastroplication starts 7 above the pylorus for the creation 3 cm gastro-ileal compression anastomosis using Metallic Anastomosis Clip (MAC) and leave a distance of 4 cm between the distal corner of the anastomosis and the pylorus. Laparoscopical the cecum and the last ileal loop are identified, and the bowel is retrogradely measured, from the ileocecal valve up to a 300 cm far from it, where the gastro-ileal anastomosis will be made. And than leave a distance of 50 cm from gastroileal anastomosis creation entero-enteric compression anastomosis using the Metallic Anastomotic Clip.
  • Procedure: Laparoscopic transit bipartition (gastroenteroanastomosis and entero-enteric anastomosis) use the Metallic Anastomotic Clip and with sleeve gastrectomy — A calibrated sleeve gastrectomy ("gastric sleeve") over a 36F calibration tube and , using stapler loads with staples of variable height. This gastric section starts 7 cm above the pylorus in order to accommodate the 3 cm gastro-ileal compression anastomosis using Metallic Anastomosis Clip (MAC) and leave a distance of 4 cm between the distal corner of the anastomosis and the pylorus. Laparoscopical the cecum and the last ileal loop are identified, and the bowel is retrogradely measured, from the ileocecal valve up to a 300 cm far from it, where the gastro-ileal anastomosis will be made. And than leave a distance of 50 cm from gastroileal compression anastomosis creation entero-enteric compression anastomosis using the Metallic Anastomotic Clip.
  • Procedure: laparoscopic duodenal transit bipartition using the Metallic Anastomotic Clip with circular fundocorporeal gastroplication without gastrectomy — The procedure begans creation circular fundocorporeal gastroplication without gastrectomy. A gastroplication calibrated over a 36F calibration tube using two layer nonabsorbable suture. The mobilisation of great curvature and gastroplication starts 4 above the pylorus. The single 3 cm size duodeno-ileal compression anastomosis by use Metallic Anastomosis Clip (MAC) creation post-pyloric at the first duodenal portion (anterior side).

Primary Outcomes

  • T2DM remission rate (Baseline, 1, 2, 3 year after surgery)
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-04-30
Completion: 2028-05-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 90 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: The Society of Bariatric and Metabolic Surgeons of Kazakhstan
Collaborators: Astana Medical University
Principal Investigators:
  • Oral Ospanov, Professor (PRINCIPAL_INVESTIGATOR) - Astana Medical University
Contact Information
Study Contact:
Oral Ospanov
Astana, Kazakhstan, 010000
bariatric.kz@gmail.com
Bakhtiyar Yelembayev
elembaevbaha@gmail.com
Interventions
  • Procedure: Laparoscopic transit bipartition with Metallic Anastomotic Clip and Circular Fundocorporeal Gastroplication — The procedure begans creation circular fundocorporeal gastroplication without gastrectomy. A gastroplication calibrated over a 36F calibration tube using two layer nonabsorbable suture. The mobilisation of great curvature starts 4 cm above the pylorus and gastroplication starts 7 above the pylorus for the creation 3 cm gastro-ileal compression anastomosis using Metallic Anastomosis Clip (MAC) and leave a distance of 4 cm between the distal corner of the anastomosis and the pylorus. Laparoscopical the cecum and the last ileal loop are identified, and the bowel is retrogradely measured, from the ileocecal valve up to a 300 cm far from it, where the gastro-ileal anastomosis will be made. And than leave a distance of 50 cm from gastroileal anastomosis creation entero-enteric compression anastomosis using the Metallic Anastomotic Clip.
  • Procedure: Laparoscopic transit bipartition (gastroenteroanastomosis and entero-enteric anastomosis) use the Metallic Anastomotic Clip and with sleeve gastrectomy — A calibrated sleeve gastrectomy ("gastric sleeve") over a 36F calibration tube and , using stapler loads with staples of variable height. This gastric section starts 7 cm above the pylorus in order to accommodate the 3 cm gastro-ileal compression anastomosis using Metallic Anastomosis Clip (MAC) and leave a distance of 4 cm between the distal corner of the anastomosis and the pylorus. Laparoscopical the cecum and the last ileal loop are identified, and the bowel is retrogradely measured, from the ileocecal valve up to a 300 cm far from it, where the gastro-ileal anastomosis will be made. And than leave a distance of 50 cm from gastroileal compression anastomosis creation entero-enteric compression anastomosis using the Metallic Anastomotic Clip.
  • Procedure: laparoscopic duodenal transit bipartition using the Metallic Anastomotic Clip with circular fundocorporeal gastroplication without gastrectomy — The procedure begans creation circular fundocorporeal gastroplication without gastrectomy. A gastroplication calibrated over a 36F calibration tube using two layer nonabsorbable suture. The mobilisation of great curvature and gastroplication starts 4 above the pylorus. The single 3 cm size duodeno-ileal compression anastomosis by use Metallic Anastomosis Clip (MAC) creation post-pyloric at the first duodenal portion (anterior side).
Study Locations (1 sites)
Oral Ospanov, Astana, 010000 Kazakhstan
Eligibility Criteria
Inclusion Criteria: * Clinical diagnosis of Type 2 Diabetes Mellitus * BMI 25-35 kg/m2 Exclusion Criteria: * Insulin dependent diabetes * BMI \<25 and \>35 kg/m2 * History of surgery on the stomach * Less than 18 or more than 65 years of age * Psychiatric illness * Patients unwilling or unable to provide informed consent
Value-based Care in Type 2 Diabetes (Enhancing T2D Care)
NCT06774950
Not yet recruiting
Conditions Diabetes Mellitus, Type 2
Phase NA
Enrollment 154
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

The aim of this study is to obtain a better glycemic index score (decrease) by improving the care and quality of life of type 2 diabetic patients for a possible remission of diabetes. This will be achieved through an intervention that includes a strategy for training primary care physicians and other healthcare professionals in patient therapeutic education (TPE), as well as group and/or individual TPE-related activities/tools made available to patients, funded and encouraged for individualized planning. Intervention follow-up will be carried out by means of quality-of-life questionnaires for patients who have undergone the new method, compared with patients who have received the usual care.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Supportive Care Masking/blinding: Double

Interventions / Regimen

  • Behavioral: Physician-patient quality circle — Intervention: (To be compared with standard care) 1. Interprofessionnal meeting per neighbourhood: (beforehand) Therapeutic patient education (TPE) training for healthcare professionals 2. Physician-patient quality circle t0 Group sessions (n= 3 to 6 patients) with doctor and therapeutic patient education specialist Clinical measurements - CM (incl. HbA1c, body composition, blood pressure). PROM evaluation questionnaires (EQ5D\&DIABQ) 3. Development of individualised T2D programme: with case manager 4. Quarterly follow-up: t3, t6, t9 months PROM follow-up (DIABQ\&PHQ9) +CM. 5. Evaluation of experience: t12 \& t18 months PREM\&PROM evaluation questionnaire +CM

Primary Outcomes

  • Glycated haemoglobin HbA1c (∆HbA1c) (During 18 month)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2025-03-01
Completion: 2027-03-01
Eligibility
Age: 40 Years
Sex: ALL
Volunteers: false
Enrollment: 154 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Réseau de soins Delta
Collaborators: University of St.Gallen
Principal Investigators:
  • Alexander Geissler, PhD (STUDY_CHAIR) - University of St.Gallen
Contact Information
Study Contact:
Minette-Joëlle MJ Zeukeng, PharmD, PhD, FPH, RPh
0041798921981
minette.zeukeng@reseau-delta.ch
Philippe Schaller, MD, MPH, FMH
0041796525116
philippe.schaller@reseau-delta.ch
Interventions
  • Behavioral: Physician-patient quality circle — Intervention: (To be compared with standard care) 1. Interprofessionnal meeting per neighbourhood: (beforehand) Therapeutic patient education (TPE) training for healthcare professionals 2. Physician-patient quality circle t0 Group sessions (n= 3 to 6 patients) with doctor and therapeutic patient education specialist Clinical measurements - CM (incl. HbA1c, body composition, blood pressure). PROM evaluation questionnaires (EQ5D\&DIABQ) 3. Development of individualised T2D programme: with case manager 4. Quarterly follow-up: t3, t6, t9 months PROM follow-up (DIABQ\&PHQ9) +CM. 5. Evaluation of experience: t12 \& t18 months PREM\&PROM evaluation questionnaire +CM
Eligibility Criteria
Inclusion Criteria: * Patients with newly diagnosed type 2 diabetes (less than 10 years) * Age (between 40 and 65) Exclusion Criteria: * Significant comorbidities linked to worsening diabetes (such as renal failure, previous myocardial infarction, retinopathy, signs or symptoms of severe diabetic neuropathy or diabetic foot ulcers), severe osteoarthritis or as judged by the attending physician. * Pregnant or breast-feeding women * Persons who are unable to give signed informed consent
Cardiovascular Disease CVD Constitutes a Significant Health Challenge for Individuals With Type 2 Diabetes Mellitus T2DM, Affecting Approximately 32% of This Population and Contributing Significantly to Global Mortality.Visceral Adipose Tissue VAT Accumulation Has Been Recognize
NCT07204782
Not yet recruiting
Conditions Diabete Mellitus
Phase Not Applicable
Enrollment 238
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

calculate cardiovascular risk scores in type 2 DM patients, then estimate its association with new visceral adipose tissue indices

Design

Study type: Observational Observational model: Case Control Time perspective: Cross Sectional

Primary Outcomes

  • The prevalence of elevated 10-year cardiovascular risk scores among patients with type 2 diabetes mellitus. (1 YEAR)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2025-12-01
Completion: 2027-07-01
Eligibility
Age: 40 Years
Sex: ALL
Volunteers: false
Enrollment: 238 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Assiut University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (1 sites)
Assiut university, Asyut, Egypt
Eligibility Criteria
Inclusion Criteria: * Adult patients ≥40 years old attending the out patients clinics * Patients diagnosed with type 2 diabetes mellitus Exclusion Criteria: * Patient with a history of cardiovascular events * Patient with type 1 diabetes or gestational diabetes. * Pregnant women. * Hypothyroidism, * Cushing disease * polycystic ovarian syndrome. * Congestive heart failure * chronic liver disease .- chronic kidney disease, * cancer * Current use of steroids, birth control pills, antipsychotics, antidepressants, epilepsy drugs. * Patients with physical deformities or conditions affecting anthropometric measurements.