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Showing 12 of 4196 trials

A Research Study Comparing How Well Different Doses of the Medicine UBT251 Lower Blood Sugar in People With Type 2 Diabetes

NCT07668388
Recruiting
Conditions Diabetes Mellitus, Type 2
Phase PHASE2
Enrollment 300
Locations 70 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The study is testing UBT251 in participants with type 2 diabetes. The purpose of this clinical study is to find out if UBT251 is effective and safe for treating participants with type 2 diabetes. Participants will either get UBT251, UBT251 placebo, semaglutide, or semaglutide placebo. Which treatment participants get is decided by chance. UBT251 is the treatment being tested and is not yet available for doctors to prescribe, while semaglutide is a medicine used to treat type 2 diabetes that doctors can already prescribe.

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Quadruple

Interventions / Regimen

  • Drug: UBT251 — UBT251 will be administered subcutaneously once-weekly.
  • Drug: UBT251 Placebo — UBT251 placebo will be administered subcutaneously once-weekly.
  • Drug: Semaglutide — Semaglutide will be administered subcutaneously once-weekly.
  • Drug: Semaglutide Placebo — Semaglutide placebo will be administered subcutaneously once-weekly.

Primary Outcomes

  • UBT251: Change in glycated haemoglobin (HbA1c) (From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40))
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: PHASE2
Status: Recruiting
Start Date: 2026-06-22
Completion: 2027-11-15
Eligibility
Age: 18 Years – 75 Years
Sex: ALL
Volunteers: false
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Novo Nordisk A/S
Principal Investigators:
  • Clinical Transparency dept. 2834 (STUDY_DIRECTOR) - Novo Nordisk A/S
Contact Information
Study Contact:
Novo Nordisk
(+1) 866-867-7178
clinicaltrials@novonordisk.com
Interventions
  • Drug: UBT251 — UBT251 will be administered subcutaneously once-weekly.
  • Drug: UBT251 Placebo — UBT251 placebo will be administered subcutaneously once-weekly.
  • Drug: Semaglutide — Semaglutide will be administered subcutaneously once-weekly.
  • Drug: Semaglutide Placebo — Semaglutide placebo will be administered subcutaneously once-weekly.
Study Locations (70 sites)
Flourish Research, Birmingham, Alabama 35205 United States
Ark Clinical Research, Fountain Valley, California 92708 United States
Ark Clinical Research, Long Beach, California 90815 United States
Los Angeles Institute for Metabolic Research, Los Angeles, California 90015 United States
Catalina Research Institute, LLC, Montclair, California 91763 United States
Encore Medical Research LLC, Hollywood, Florida 33024 United States
South Broward Research LLC, Miramar, Florida 33027 United States
Encore Medical Research of Weston, Weston, Florida 33331 United States
Midwest Inst For Clin Res, Indianapolis, Indiana 46260 United States
Cotton O'Neil Diabetes & Endocrinology, Topeka, Kansas 66606 United States
Eligibility Criteria
Inclusion Criteria: * Male or female (sex assigned at birth, inclusive of all gender identities). * Age 18-75 years (both inclusive) at the time of signing the informed consent. * Diagnosed with type 2 diabetes greater than or equal to (≥) 180 days before screening. * Stable daily dose(s) ≥ 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without sodium-glucose cotransporter-2 (SGLT2) inhibitor. * HbA1c of 7.0-10.5 percent (%) (53-91 millimoles per mole (mmol/mol)) (both inclusive) as assessed by central laboratory at screening. * Body mass index between 25.0 kg/m\^2 and 50.0 kg/m\^2 (both inclusive) at screening. Exclusion Criteria: * Treatment with any medication (prescription or over-the counter) or alternative remedies for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire, question 8.

QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy

NCT07775846
Recruiting
Conditions Type 2 Diabetic Kidney Disease
Phase PHASE4
Enrollment 820
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This study employs a prospective, randomized, double-blind, parallel-controlled design, aiming to enroll adult participants with type 2 diabetic kidney disease (DKD) who meet the eligibility criteria. With an angiotensin receptor blocker (ARB) as the background therapy, all participants will be randomized in a 1:1:1:1 ratio into four treatment groups: Group 1 (G1): ARB + empagliflozin + finerenone placebo + mazdutide placebo; Group 2 (G2): ARB + empagliflozin + finerenone + mazdutide placebo; Group 3 (G3): ARB + empagliflozin + mazdutide + finerenone placebo; Group 4 (G4): ARB + empagliflozin + mazdutide + finerenone. The primary comparisons include G2 vs. G1, G3 vs. G1, G4 vs. G2, and G4 vs. G3, designed to evaluate the superiority of triple therapy over dual therapy, and quadruple therapy over triple therapy, in reducing the urine albumin-to-creatinine ratio (UACR).

Design

Study type: Interventional Phases: Phase4 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Quadruple

Interventions / Regimen

  • Drug: empagliflozin — Oral tablet, administered at a fixed dose of 10 mg once daily for 6 months.
  • Drug: Finerenone — Oral tablet, taken once daily for 6 months. Initial dose is 10 mg or 20 mg once daily adjusted based on baseline eGFR (20 mg for eGFR \>= 60 mL/min/1.73m²; 10 mg for eGFR 30-60 mL/min/1.73m²). Subsequent dose adjustments are guided by serum potassium levels and renal function.
  • Drug: Mazdutide — Once-weekly subcutaneous injection for 6 months, following a mandatory dose-escalation schedule: initiated at 2 mg once weekly for 4 weeks, up-titrated to 4 mg once weekly for 4 weeks (if tolerated), and further increased to 6 mg once weekly as the target maintenance dose.
  • Drug: Finerenone Placebo — Oral tablet matching active finerenone in appearance and scheduling, without active ingredients, taken once daily for 6 months.
  • Drug: Mazdutide Placebo — Once-weekly subcutaneous injection matching active mazdutide in appearance and scheduling, without active ingredients, for 6 months.
  • Drug: Angiotensin Receptor Blocker (ARB) — Standard background therapy, titrated to a stable dose for at least 4 weeks prior to enrollment and maintained throughout the 6-month study period.

Primary Outcomes

  • Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Month 6 (Baseline and Month 6)
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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: PHASE4
Status: Recruiting
Start Date: 2026-11-03
Completion: 2029-06-30
Eligibility
Age: 18 Years – 70 Years
Sex: ALL
Volunteers: false
Enrollment: 820 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Huijie Zhang
Contact Information
Study Contact:
jingjing jiang, PhD
13402003919
jiang.jingjing@zs-hospital.sh.cn
Jingjing JIANG
86-021-64041990
jiang.jingjing@zs-hospital.sh.cn
Zhongshan Hospital, Fudan University
Huijie Zhang
Zhongshan Hospital, Fudan University
Interventions
  • Drug: empagliflozin — Oral tablet, administered at a fixed dose of 10 mg once daily for 6 months.
  • Drug: Finerenone — Oral tablet, taken once daily for 6 months. Initial dose is 10 mg or 20 mg once daily adjusted based on baseline eGFR (20 mg for eGFR \>= 60 mL/min/1.73m²; 10 mg for eGFR 30-60 mL/min/1.73m²). Subsequent dose adjustments are guided by serum potassium levels and renal function.
  • Drug: Mazdutide — Once-weekly subcutaneous injection for 6 months, following a mandatory dose-escalation schedule: initiated at 2 mg once weekly for 4 weeks, up-titrated to 4 mg once weekly for 4 weeks (if tolerated), and further increased to 6 mg once weekly as the target maintenance dose.
  • Drug: Finerenone Placebo — Oral tablet matching active finerenone in appearance and scheduling, without active ingredients, taken once daily for 6 months.
  • Drug: Mazdutide Placebo — Once-weekly subcutaneous injection matching active mazdutide in appearance and scheduling, without active ingredients, for 6 months.
Study Locations (1 sites)
Zhongshan Hospital, Fudan University, Shanghai, Shanghai Municipality 201508 China
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years, with a confirmed diagnosis of type 2 diabetes mellitus (T2DM). * Receiving a standard dose of an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) therapy for at least 4 consecutive weeks prior to screening, with the dose expected to remain stable throughout the study period. * Body Mass Index (BMI) ≥ 24.0 kg/m2. * Mean urine albumin-to-creatinine ratio (UACR) ≥ 100 mg/g and \< 5000 mg/g, calculated from first morning void urine samples collected over 3 consecutive days. * Estimated glomerular filtration rate (eGFR) based on the CKD-EPI formula ≥ 30 mL/min/1.73m2. * Serum potassium level ≤ 4.8 mmol/L. * Glycated hemoglobin (HbA1c) \< 11%. * Voluntarily understood and signed the written Informed Consent Form (ICF). Exclusion Criteria: * Definite diagnosis of non-diabetic kidney disease (e.g., IgA nephropathy, polycystic kidney disease, lupus nephritis, etc). * Personal or family history of medullary thyroid carcinoma (MTC), or a diagnosis of multiple endocrine neoplasia syndrome type 2 (MEN 2). * History of severe acute or chronic pancreatitis. * History of diabetic ketoacidosis (DKA). * Symptomatic hypotension during the screening period, or a resting systolic blood pressure (SBP) \< 110 mmHg. * Refractory hypertension, defined as a resting SBP \> 170 mmHg despite the concurrent use of three antihypertensive medications. * History of severe dehydration, severe diarrhea, or acute volume depletion within 30 days prior to screening. * History of acute kidney injury (AKI) within 30 days prior to screening. * Use of traditional Chinese medicines with potential proteinuria-lowering effects (e.g., Keluoxin capsules, Huangkui capsules, or Shenyan Kangfu tablets) within 30 days prior to screening. * Use of potassium-sparing diuretics (e.g., triamterene or amiloride) or mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone, or finerenone) within 2 months prior to screening. * Use of GLP-1 receptor agonists, GLP-1/GIP dual receptor agonists, or GLP-1/glucagon (GCG) dual receptor agonists within 6 months prior to screening. * Current use of strong CYP3A4 inhibitors (e.g., itraconazole or clarithromycin) or CYP3A4 inducers that may significantly interfere with finerenone metabolism. * Myocardial infarction, unstable angina, stroke, or hospitalization due to heart failure (NYHA Class III-IV) within 3 months prior to screening. * Active urogenital tract infection, or a history of urogenital tract infection associated with the prior use of SGLT2 inhibitors. * Women who are pregnant, planning to become pregnant, or lactating. * Inability to complete the 6-month follow-up due to general health conditions or geographic relocation. * Any other condition that, in the opinion of the investigator, renders the participant unsuitable for participation in the study.

Digital Dietary Intervention for Patients Receiving GLP-1 Receptor Agonist Therapy

NCT07728669
Recruiting
Conditions Type 2 Diabetes Mellitus (T2DM), Obesity...
Phase NA
Enrollment 120
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this clinical trial is to learn whether adding the NutriSteppe digital dietary intervention to routine medical care improves metabolic health in adults aged 21 to 65 years with type 2 diabetes mellitus, obesity, or overweight with related health conditions. Participants are already receiving or have been prescribed glucagon-like peptide-1 (GLP-1) receptor agonist therapy by their treating physicians outside the study. The main question is: Does the NutriSteppe digital dietary intervention improve glycated hemoglobin (HbA1c), a measure of average blood glucose, after 12 weeks compared with routine medical care alone? The study will also assess changes in fasting blood glucose, body weight, body mass index, waist circumference, cholesterol, triglycerides, blood pressure, diet quality, quality of life, dietary adherence, and safety. Researchers will randomly assign participants to one of two groups. The control group will continue routine medical care and receive general lifestyle advice. The intervention group will continue routine medical care and use the NutriSteppe application for 12 weeks to receive personalized dietary support. Participants in both groups will: * Attend study visits and complete the examinations, laboratory tests, and questionnaires specified in the study protocol. * Photograph everything they eat and drink. * Have their food photographs automatically analyzed using Tagam-AI, a system developed for this study. * Be able to view the results of the food photograph analysis. The photography and automated analysis procedures will be the same in both groups. Only participants in the intervention group will receive personalized dietary recommendations generated from these data through the NutriSteppe application.

Design

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

Interventions / Regimen

  • Behavioral: NutriSteppe Digital Dietary Intervention — The NutriSteppe mobile application provides personalized meal planning, a food diary, nutritional analysis, dietary goals, educational modules, culturally adapted recipes, progress monitoring, reminders, and dietary recommendations intended to support metabolic health and food tolerance during GLP-1 receptor agonist therapy. Participants use the application for 12 weeks, complete the food diary at least 5 days per week, record body weight weekly, review dietary suggestions, and complete weekly educational modules.

Primary Outcomes

  • Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 (Baseline and Week 12)
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: Recruiting
Start Date: 2026-07-20
Completion: 2027-01
Eligibility
Age: 21 Years – 65 Years
Sex: ALL
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Kazakh Academy of Nutrition
Collaborators: Science Committee of the Ministry of Science and Higher Education of the Republic of Kazakhstan
Principal Investigators:
  • Almaz Sharman, MD, PhD (PRINCIPAL_INVESTIGATOR) - Kazakh Academy of Nutrition LLP
Contact Information
Study Contact:
Ayaulym Omirbekova
+77757211170
a.omirbekova@academypm.org
Almaz Sharman
+77771114202
Almaz@Sharman.pro
Kazakh Academy of Nutrition LLP
Interventions
  • Behavioral: NutriSteppe Digital Dietary Intervention — The NutriSteppe mobile application provides personalized meal planning, a food diary, nutritional analysis, dietary goals, educational modules, culturally adapted recipes, progress monitoring, reminders, and dietary recommendations intended to support metabolic health and food tolerance during GLP-1 receptor agonist therapy. Participants use the application for 12 weeks, complete the food diary at least 5 days per week, record body weight weekly, review dietary suggestions, and complete weekly educational modules.
Study Locations (1 sites)
Kazakh Academy of Nutrition LLP, Almaty, 050008 Kazakhstan
Eligibility Criteria
Inclusion Criteria: * Age 21-65 years inclusive at the time of signing informed consent. * Male or female. * Overweight with at least one comorbidity, including diabetes mellitus; arterial hypertension of at least 130/85 mmHg or use of antihypertensive medication; dyslipidemia defined as triglycerides of at least 1.7 mmol/L, reduced HDL cholesterol below 1.0 mmol/L in men or below 1.3 mmol/L in women, or use of lipid-lowering medication; cardiovascular disease; respiratory or joint disease; non-alcoholic fatty liver disease; sleep disorders; or other comorbidities. * For participants with overweight: body mass index of 25.0-29.9 kg/m² for the Caucasian population or 23.0-27.4 kg/m² for the Asian population, together with abdominal obesity defined as waist circumference of at least 94 cm in men and 80 cm in women of the European population, or at least 90 cm in men and 80 cm in women of the Asian population. * Class I-III obesity where diet combined with physical activity has been ineffective, defined as weight loss of less than 5% over 3 months. * Class I obesity: body mass index of 30.0-34.9 kg/m² for the Caucasian population or 27.5-32.4 kg/m² for the Asian population. * Class II obesity: body mass index of 35.0-39.9 kg/m² for the Caucasian population or 32.5-37.4 kg/m² for the Asian population. * Type 2 diabetes mellitus with HbA1c of at least 6.5% (48 mmol/mol), fasting glucose of at least 6.1 mmol/L in capillary whole blood or at least 7.0 mmol/L in venous plasma, glucose of at least 11.1 mmol/L two hours after an oral glucose tolerance test, or random glucose of at least 11.1 mmol/L. * Body mass index of at least 25 kg/m² and no more than 40 kg/m² at screening. * Already receiving, or prescribed, GLP-1 receptor agonist therapy with semaglutide by the treating physician independently of the study. The study does not prescribe or modify this therapy. * Stable doses of medications for chronic conditions, including antihypertensive agents and statins, for at least 8 weeks before screening. * Ownership of an iOS or Android smartphone with internet access and willingness to download and use the "NutriSteppe" application if assigned to the intervention group. * Ability and willingness to provide written informed consent and comply with study procedures. * Women of childbearing potential must use effective contraception throughout the study. Exclusion Criteria: * Diagnosis of type 1 diabetes mellitus. * History of diabetic ketoacidosis or hyperglycemic hyperosmolar state. * Initiation of GLP-1 receptor agonist therapy less than 4 weeks before screening. * Current insulin therapy. * Personal or family history of medullary thyroid carcinoma. * Personal history of multiple endocrine neoplasia type 2 (MEN2). * History of acute or chronic pancreatitis. * Active gallbladder disease or history of gallbladder disease within 6 months before screening. * Severe gastrointestinal disease, including gastroparesis. * Major cardiovascular event within 6 months before screening, including myocardial infarction, stroke, transient ischemic attack, unstable angina, coronary artery bypass grafting, or percutaneous coronary intervention. * Uncontrolled arterial hypertension, defined as systolic blood pressure above 160 mmHg or diastolic blood pressure above 100 mmHg at screening. * Chronic kidney disease with an estimated glomerular filtration rate below 30 mL/min/1.73 m² using the MDRD or CKD-EPI formula. * Severe hepatic impairment classified as Child-Pugh class C, or ALT or AST greater than three times the upper limit of normal. * Active malignancy or history of malignancy within 5 years, except successfully treated basal cell or squamous cell carcinoma of the skin. * Established HIV infection, active hepatitis B defined as HBsAg positive with detectable HBV DNA, or hepatitis C virus infection. * History of bariatric surgery or bariatric surgery planned during the study. * Anorexia nervosa, bulimia nervosa, or binge eating disorder diagnosed or active within the past year. * Pregnancy or breastfeeding. * Planning pregnancy during the study. * Woman of childbearing potential unwilling to use effective contraception. * Use of weight-loss medication, including orlistat, phentermine, combinations with topiramate, naltrexone-bupropion, or other weight-loss medication within 3 months before screening. * Use of systemic corticosteroids, excluding inhaled or topical corticosteroids, for more than 2 weeks within 3 months before screening. * Use of antipsychotic medication associated with significant weight gain unless used at a stable dose for more than 6 months. * Participation in another interventional clinical study within 30 days before screening. * Known hypersensitivity to semaglutide or any excipient. * No smartphone or unwillingness to use digital health technology. * Severe mental disorder impairing the ability to provide informed consent or comply with the protocol. * Active alcohol or drug dependence within the past year. * Any condition that, in the investigator's opinion, may compromise participant safety or the integrity of the study.

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 Not reported — ask the study team
Data Updated 2026-11-12
View Trial Details Official Listing I'm Interested
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
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-06-01
Completion: 2026-12-31
Eligibility
Age: 18 Years – 69 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
Yuhong Zeng
0086 13980605563
clinicalresearchcenter@med.uestc.edu.cn
Sichuan Provinvial People's HSichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital（ SAMS&SPPH，Affiliated Hospital of UESTC）ospital
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.

The Effect Of Acupressure and Foot Exercise on Ankle Brachial Index in Individuals With Type 2 Diabetes

NCT06271382
Recruiting
Conditions Diabetes Mellitus, Type 2
Phase NA
Enrollment 60
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This study was planned with a randomized controlled experimental design to examine the effects of acupressure and ankle exercises on ankle brachial index in individuals with Type 2 diabetes.

Design

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

Interventions / Regimen

  • Other: Acupressure Group — In the research, the participant in the acupressure group will receive acupressure application 3 times a week for 2 weeks, a total of 6 times. Depending on the preparation and pressure time on the 5 selected points (a total of 10 points will be applied since the partner of each point on the other extremity will be applied), the session duration for an individual will be approximately 18-20 minutes.
  • Other: Sham Acupressure Group — Depending on the preparation and pressure time on the 5 selected sham points (a total of 10 points will be applied since the partner of each point on the other extremity will be applied), the session duration for an individual will be approximately 18-20 minutes. Patients in the sham acupressure group will receive acupressure 6 times in total, 3 times a week for 2 weeks. The practitioner will do the first acupressure at the Family Health Center, and the person with type 2 diabetes will do the others at home. Ankle Brachial Index evaluation will be performed by the researcher at the Family Health Center a total of 3 times before the intervention, 1 week after the intervention and 2 weeks after the intervention.
  • Other: Foot Ankle Exercise Group — Exercise will be performed regularly for 2 weeks, 3 days a week for a maximum of 30 minutes.

Primary Outcomes

  • Ankle Brachial Index (2 week)
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: Recruiting
Start Date: 2025-02-24
Completion: 2025-04-24
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: true
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Abant Izzet Baysal University
Principal Investigators:
  • Saadet CAN ÇİÇEK (STUDY_DIRECTOR) - http://www.ibu.edu.tr/tr
Contact Information
Study Contact:
Saadet Semra AKTAŞ
+905314914448
semraaktas140@hotmail.com
Saadet CAN ÇİÇEK
+905062846936
saadet.cancicek@ibu.edu.tr
Beşkavakalar Aile Sağlığı Merkezi Aile Sağlığı Merkezi
+903742705005
semraaktas140@gmail.com
Beşkavaklar Aile Sağlığı Merkezi
Interventions
  • Other: Acupressure Group — In the research, the participant in the acupressure group will receive acupressure application 3 times a week for 2 weeks, a total of 6 times. Depending on the preparation and pressure time on the 5 selected points (a total of 10 points will be applied since the partner of each point on the other extremity will be applied), the session duration for an individual will be approximately 18-20 minutes.
  • Other: Sham Acupressure Group — Depending on the preparation and pressure time on the 5 selected sham points (a total of 10 points will be applied since the partner of each point on the other extremity will be applied), the session duration for an individual will be approximately 18-20 minutes. Patients in the sham acupressure group will receive acupressure 6 times in total, 3 times a week for 2 weeks. The practitioner will do the first acupressure at the Family Health Center, and the person with type 2 diabetes will do the others at home. Ankle Brachial Index evaluation will be performed by the researcher at the Family Health Center a total of 3 times before the intervention, 1 week after the intervention and 2 weeks after the intervention.
  • Other: Foot Ankle Exercise Group — Exercise will be performed regularly for 2 weeks, 3 days a week for a maximum of 30 minutes.
Study Locations (1 sites)
Beşkavaklar Aile Sağlığı Merkezi, Bolu, Turkey (Türkiye)
Eligibility Criteria
Inclusion Criteria: * Being diagnosed with type 2 diabetes * Be 18 years or older * Ability to speak Turkish * Ability to establish verbal communication * Volunteering to participate in the research Exclusion Criteria: * Presence of any psychiatric disease diagnosed by a physician * Presence of diabetic ulcers on both feet and legs * Presence of any amputation in the foot or leg * Having myalgia in the foot, * Foot fracture * Edema in the feet

Adaptive Mechanisms In GRown up ObeSity Study (AMIGROS)

NCT06065930
Recruiting
Conditions Obesity, Type 2 Diabetes
Phase Not Applicable
Enrollment 45
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The investigator recently showed that the glycan-binding adipokine galectin-1 increased during overfeeding and that galectin-1 independently could predict type 2 diabetes. Further, the molecules that induce insulin release in the fasting state when blood glucose is normal remain elusive. It is possible that galectin-1 is involved in adaptive mechanisms in adipose tissue in obese subjects.

Design

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

Interventions / Regimen

  • Device: Subcutaneous microdialysis — Group with Ob-IS participants, collection of abdominal subcutaneous interstitial dialysates after an overnight´s fast for later measurements of metabolites and peptides eg galectin-1. Group with Ob-IR participants, collection of abdominal subcutaneous interstitial dialysates after an overnight´s fast for later measurements of metabolites and peptides eg galectin-1. Group with Leans, collection of abdominal subcutaneous interstitial dialysates after an overnight´s fast for later measurements of metabolites and peptides eg galectin-1.

Primary Outcomes

  • Fasting galectin-1 concentration in subcutaneous interstitial fluid (Three weeks)
  • Fasting Neuropilin-1 concentration in subcutaneous interstitial fluid (Three weeks)
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: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2023-05-05
Completion: 2028-12-31
Eligibility
Age: 40 Years – 70 Years
Sex: ALL
Volunteers: true
Enrollment: 45 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Vastra Gotaland Region
Collaborators: Göteborg University
Principal Investigators:
  • Per-Anders Jansson, Prof (PRINCIPAL_INVESTIGATOR) - Region Vastra Gotaland
Contact Information
Study Contact:
Per-Anders E Jansson, Prof
46 70 203 30 10
per-anders.jansson@wlab.gu.se
Vagner R Silva, PhD
46 76 849 77 03
vagner.silva@wlab.gu.se
Anna-Carin Varvne, Manager
46 70 082 50 91
anna-carin.varvne@vgregion.se
Gothia Forum CTC
Interventions
  • Device: Subcutaneous microdialysis — Group with Ob-IS participants, collection of abdominal subcutaneous interstitial dialysates after an overnight´s fast for later measurements of metabolites and peptides eg galectin-1. Group with Ob-IR participants, collection of abdominal subcutaneous interstitial dialysates after an overnight´s fast for later measurements of metabolites and peptides eg galectin-1. Group with Leans, collection of abdominal subcutaneous interstitial dialysates after an overnight´s fast for later measurements of metabolites and peptides eg galectin-1.
Study Locations (1 sites)
Gothia Forum CTC, Gothenburg, Region Vastra Gotaland SE-413 46 Sweden
Eligibility Criteria
Inclusion Criteria: 1. Men and women of age: 40.0 - 70.0 years 2. BMI: 18.0 - 25.0 kg/m2 (lean subjects) and BMI 30.0 - 38.0 kg/m2 (Ob-IS and Ob-IR) 3. Fasting insulin \< 9.0 mU/l (lean and Ob-IS subjects) and fasting insulin \> 9.0 mU/l (Ob-IR) 4. Fasting glucose \< 6.1 mmol/l 5. Body temperature \< 37.5°C 6. First-degree relative with known T2D in Ob-IR 7. Weight stable ± 5 kg \< 3 months before screening 8. Fluent in Swedish and can follow given instructions 9. Consent given to participate Exclusion Criteria: 10. First-degree relative with known T2D in lean or Ob-IS subjects 11. Alcohol intake \> 10 units/week or known high alcohol intake \< 10 years back in time 12. Daily use of cigarettes or daily frequent use of smokeless tobacco not enabling the participant to suspend nicotine during a visit at the research center without getting abstinent 13. Regular physical activity corresponding to Saltin-Gimby level 4 14. Special diet eg Atkins or 5:2 for weight reduction. Vegetarian food accepted if duration \> 1 year 15. Impaired fasting glucose (IFG) (venous fasting plasma glucose 6.1-6.9 mmol/l) 16. Type 2 diabetes according to ADA criteria 17. Ongoing or previous ischemic heart disease, eg angina pectoris, unstable angina or previous myocardial infarction treated with platelet inhibitors or non vitamin-K oral anticoagulants 18. Heart failure (NYHA II-IV) or cardiac arrhytmia that needs medical treatment 19. Previous cerebral infarction or transitory ischemic episodes (TIA) treated with platelet inhibitors or other anticoagulants 20. Peripheral arterial insufficiency eg claudication 21. Hypertension \>170/105 mmHg at screening or more than one class of drugs for treatment of known hypertension 22. Lipid disorder defined as fasting serum triglycerides \> 5.0 mmol/l or serum cholesterol \> 7.5 mmol/l 23. Hematologic diseases such as anemia not being substituted (Hb \< 130 g/l in males and Hv \< 120 g/l in females) or disease causing bleeding disorder 24. Renal failure defined as absolute estimated glomerular filtration rate (eGFRcreatinine) \< 60 ml/min/1.73 m2 25. Hypothyroidism defined as TSH \> 4.0 mIE/l and symptoms 26. Liver disease e.g. hepatitis B, cirrhosis or conditions where AST or ALT are \> 2 times UNL 27. Systemic inflammatory disease e.g. rheumatoid arthritis, ulcerative cholitis or Chrons disease. Celiac disease, dyspepsia or IBS are excepted 28. Chronic bronchitis or chronic obstructive pulmonary with disease symptoms 29. Previous pancreatitis or other disease in pancreas that needs treatment 30. Migraine elicited by stress 31. Spinal insufficiency causing inconvenience lying in supine position during the study day 32. Drug addiction interfering with the study procedures 33. Psychiatric insufficiency interfering with the study procedures 34. Medication with potential to affect adipose tissue metabolism that can not be stopped 10 days before the study days 35. Treatment with beta-blockers 36. Less than three months from previous use of antibiotics 37. Cancer disease \< 5 years since diagnosis 38. Physical examination or laboratory results indicating that participation in the study is inappropriate 39. Pregnancy or intention to be pregnant during the study 40. Shift work \> 1 time per week that might interfere with the circadian rhytm 41. Other reasons that causes the PI to believe that participation is inappropriate

A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity

NCT07595549
Recruiting
Conditions Obesity, Overweight and/or Obesity, Over...
Phase PHASE3
Enrollment 954
Locations 80 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this clinical study is to learn about the effects and safety of berobenatide (PF-08653944). This may help people with overweight or obesity lose weight. People in this study may also have type 2 diabetes. About 950 adults will be in this study. Berobenatide will be compared to a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. Berobenatide or placebo is given by a shot under the skin in the belly area. The objective of the study is to compare the experiences of people receiving berobenatide to those of the people who do not to assess if the study medicine is effective and safe. People will take part in this study for about 20 months. During this time, they will have about 15 study visits at the site. They will also have 2 study visits over the phone.

Design

Study type: Interventional Phases: Phase3 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Double

Interventions / Regimen

  • Drug: PF-08653944 — By Subcutaneous Injection
  • Other: Placebo — By Subcutaneous Injection

Primary Outcomes

  • Percent change from baseline in body weight (Baseline, Week 72)
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: PHASE3
Status: Recruiting
Start Date: 2026-06-10
Completion: 2028-06-21
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 954 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Pfizer
Principal Investigators:
  • Pfizer CT.gov Call Center (STUDY_DIRECTOR) - Pfizer
Contact Information
Study Contact:
Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
Interventions
  • Drug: PF-08653944 — By Subcutaneous Injection
  • Other: Placebo — By Subcutaneous Injection
Study Locations (80 sites)
San Fernando Valley Health Institute, Canoga Park, California 91304 United States
Headlands Research California, LLC, Escondido, California 92025 United States
ImmuniMet, LLC, Modesto, California 95350 United States
Clinical Trials Research, Sacramento, California 95821 United States
University Clinical Investigators, Inc., Tustin, California 92780 United States
Diablo Clinical Research, Inc., Walnut Creek, California 94598 United States
Southern California Retina Specialists, West Hills, California 91307 United States
Nature Coast Clinical Research, Crystal River, Florida 34429 United States
West Coast Eye Institute, Lecanto, Florida 34461 United States
South Broward Research, Miramar, Florida 33027 United States
Eligibility Criteria
Inclusion Criteria: * Aged ≥18 years. * BMI of: ≥30 kg/m2 or ≥27.0 kg/m2 to \<30.0 kg/m2 and must have at least 1 of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D. Exclusion Criteria: * Have a self-reported body weight change greater than 5% within 90 days prior to Screening. * Diagnosis of type 1 diabetes or any other form of diabetes other than T2D. * History of acute or chronic pancreatitis. * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).

Liver Fat as a Dietary Target of the Chinese Medical Nutrition Therapy (CMNT) Diet for Treating Type 2 Diabetes With Nonalcoholic Fatty Liver Disease

NCT05439226
Recruiting
Conditions Type 2 Diabetes
Phase NA
Enrollment 120
Locations 3 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

Type 2 diabetes (T2D) represents a serious public health problem. Patients with T2D and non-alcoholic fatty liver disease(NAFLD) demonstrate a poor metabolic profile and increase mortality compared with patients with only NAFLD or T2D. Nutritional intervention is the most basic treatment for T2D. Previous study showed that a Chinese medical nutrition therapy (CMNT) diet, which intermittent use of low-calorie medicinal food, has a glucose-lowering effect in T2D. This study aims to investigate the effect of a Chinese medical nutrition therapy (CMNT) diet accompanied by intermittent energy restriction on reducing liver fat and glycated hemoglobin (HbA1c) in patients with T2D and NAFLD.

Design

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

Interventions / Regimen

  • Other: CMNT diet — Hypocaloric CMNT diet plan: A diet plan with intermittent use of enriched traditional-Chinese-medicinal-foods CMNT diet

Primary Outcomes

  • Controlled attenuation parameter (CAP) value by transient elastography (3, 6, 12, 24 months)
  • HbA1C (3, 6, 12, 24 months)
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: Recruiting
Start Date: 2022-07-05
Completion: 2026-06-05
Eligibility
Age: 18 Years – 75 Years
Sex: ALL
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: State Key Laboratory of Subhealth Intervention Technology
Contact Information
Study Contact:
Luo wu
13687333270
luowubio@163.com
Yang xiao
15200877395
31884210@qq.com
Jian Li
18942546818@163.com
Physical Examination Center of Gezhouba central hospital of Sinopharm
Interventions
  • Other: CMNT diet — Hypocaloric CMNT diet plan: A diet plan with intermittent use of enriched traditional-Chinese-medicinal-foods CMNT diet
Study Locations (3 sites)
Physical Examination Center of Gezhouba central hospital of Sinopharm, Yichang, Hubei China
Hunan Shanshui physical examination center, Changsha, Hunan China
Jinheyuan Outpatient Department, National Sub-health Intervention Technology Achievement Application Center, Changsha, Hunan China
Eligibility Criteria
Inclusion Criteria: * Patients diagnosed with type 2 diabetes and NAFLD * Age between 18 and 75 years * BMI between 18.0 and 35.0 kg/m2 * Weight stable for at least 3 months prior to the study (gain or loss \< 4 kg) * Stable treatment for at least 3 months with 1-3 oral antidiabetic medications (with or without insulin therapy), or not yet received antidiabetic medication prior to the beginning of the study * Able to give written informed consent Exclusion Criteria: * Self-reported a food allergy * Alcohol abuse in the last 3 months (alcohol intake greater than 20 g per day for women; Alcohol intake for men greater than 40 g per day) * Other liver diseases such as chronic hepatitis B and C, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, nodular regenerative hyperplasia and focal nodular hyperplasia * Scheduled to be hospitalized for any surgical treatment during screening * Pregnant or planning of pregnancy during the study * Inability, physically or mentally, to adhere the procedures required by the study protocol * Level 3 hypoglycemic events (at least 3 times) occurring within the 90 days prior to screening * Hospitalization or emergency department visit for hyperglycemia, diabetic ketoacidosis, lactic acidosis, hyperosmolar nonketotic coma, or diabetes * History of cancer within the past 5 years * Acute coronary or cerebrovascular event in the past 90 days, or heart failure * Hemorrhagic or ischemic stroke within the last 6 months

Effect of Henagliflozein on Hepatic Fat Content in Patients With T2DM and NAFLD

NCT06449833
Recruiting
Conditions Type2 Diabetes Mellitus, Nonalcoholic Fa...
Phase PHASE4
Enrollment 100
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This study focuses on the effects of Henagliflozein on hepatic fat content in patients with type 2 diabetes mellitus (DM) and nonalcoholic fatty liver disease (NAFLD). Sponsored by Zhujiang Hospital of Southern Medical University, this study is a multi-center, randomized, controlled clinical trial, aiming at exploring the difference in the reduction of liver fat content in the subjects compared with the control group after 24 weeks of treatment. Subjects from different medical centers diagnosed with T2DM and NAFLD will be randomly assigned to the treatment or control group in a 1:1 ratio, and subsequently initiate the intervention period of 24 weeks. In this trial, patients will be treated with 10 mg of Henagliflozein + metformin and 5 mg of Linagliptin + metformin as control, and the dose of metformin will be customized at 500-1500mg according to their individual blood glucose level. The check-points are set at the 8th, 16th and 24th week of the follow-up after the treatment, and nutritionists are available to provide dietary and exercise guidance.

Design

Study type: Interventional Phases: Phase4 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Double

Interventions / Regimen

  • Drug: Henagliflozein and Metformin — The experimental group will be treated with 10mg Henagliflozein and Metformin.
  • Drug: Linagliptin and Metformin — The control group will be treated with 5mg Linagliptin and Metformin.

Primary Outcomes

  • The difference of liver fat content (magnetic resonance imaging proton density fat fraction,MRI-PDFF)) between the subjects and the control group. (24 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: PHASE4
Status: Recruiting
Start Date: 2024-06
Completion: 2026-11
Eligibility
Age: 18 Years – 75 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Zhujiang Hospital
Principal Investigators:
  • Hong Chen, MD (PRINCIPAL_INVESTIGATOR) - Zhujiang Hospital
Contact Information
Study Contact:
Hong Chen, MD
13602759769
rubychq@163.com
Interventions
  • Drug: Henagliflozein and Metformin — The experimental group will be treated with 10mg Henagliflozein and Metformin.
  • Drug: Linagliptin and Metformin — The control group will be treated with 5mg Linagliptin and Metformin.
Study Locations (1 sites)
Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong 510000 China
Eligibility Criteria
Inclusion Criteria: 1. Patients diagnosed with type 2 diabetes within 5 years (According to the diagnostic criteria of WHO Diabetes Classification 2019) 2. Patients who are aware of the purpose of the trail, willing to participate in the trial and sign informed consent forms, and comply with all requirements (including those during follow-up and evaluation investigations) 3. Well-controlled blood glucose through diet and exercise intervention, or stable treatment with 1 or 2 types of hypoglycemic drugs (metformin, sulfonylurea, glinide, α-glycosidase inhibitor ) for at least 8 weeks with a half or full recommended maximum tolerated dose in instructions. 4. HbA1c: 7.0%-8.5% 5. Patients diagnosed with non-alcoholic fatty liver disease (According to the diagnostic criteria of Guidelines for Diagnosis and Treatment of Non-alcoholic Fatty Liver Disease 2010) Exclusion Criteria: 1. Patients with type 1 diabetes, gestational diabetes or other special types of diabetes; 2. Patients with any acute, chronic complication or risk that may cause greater adverse effects than benefits through the trial; or receiving other treatment currently that may affect subjects' compliance or the objectivity of the end point of this trial; (1)Patients with serious acute complications of diabetes in the past 6 months (Eg. diabetic ketoacidosis, hyperosmotic hyperglycemia coma); (2)Patients with unstable proliferative retinopathy or maculopathy,severe diabetic neuropathy, intermittent claudication or diabetic foot in the past 6 months; (3)Patients with serious liver dysfunction and chronic kidney disease or disease of other systems (Eg. Acute and chronic pancreatitis, liver cirrhosis, nephrotic syndrome ect. ); and those who do not meet the requirements after being evaluated by professionals; (4)Have a history of myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, or underwent coronary angioplasty, percutaneous coronary stenting or coronary artery bypass grafting 6 months before the screening; or screening for congestive heart failure (New York Heart Association NYHA grade III and IV), unstable or acute congestive heart failure, or persistent arrhythmias believed to be life-threatening within the first 6 months of the trail; (5)Have a history of hemorrhagic stroke or ischemic stroke in the past 6 months, and was evaluated by the researchers as not suitable to participate in this clinical trial; (6)Have a history of hypertension and was not effectively controlled before screening: systolic blood pressure (SBP) ≥ 160mmHg and / or diastolic blood pressure (DBP) ≥ 100mmHg; 3. Have a history of other endocrine system diseases which affect glucose and lipid metabolism or have an effect on the body weight, such as: multiple endocrine adenomatosis, acromegaly, Cushing syndrome, hyperthyroidism; 4. Have a history of malignant tumour within 5 years before screening, except for local basal cell carcinoma of the skin after treatment； 5. Have a history of severe infection, trauma or major surgery within 3 months; 6. Have a history of drug abuse with 5 years, including repeated use of dependence-producing drug unrelated to medical purposes, including addictive and habitual drugs leading to physical and psychic dependence; 7. Have a history of participating any intervention drug or instrumental clinical trial 3 months before screening; 8. Have a history of severe anemia or need regular blood transfusion treatment; 9. Have a history of any medication or treatment below: (1)Using drugs that may cause weight change 90 days before screening, including diuretics, weight-loss drug etc.; (2)Using drugs that may affect blood glucose for \>1 week within 12 weeks, such as oral/intravenous glucocorticoid, growth hormone, estrogen/progesterone, high-dose diuretics, antipsychotic drugs, etc., but low-dose diuretics for antihypertensive purposes (hydrochlorothiazide \< 25mg/d, indapamide \< 1.5 mg/d) are not included in this restriction; (3)Had bariatric sugery or planning to have bariatric surgery; 10.The laboratory results of patients meet the following standards: 1. AlanineAminotransferase(ALT)and/oraspartateaminotransferase(AST) higher than 5 times of the upper limit of the normal value. 2. Glomerular Filtration Rate (eGFR) estimated by CKD-EPI formula \< 40mL/ (min·1.73m2); 11.Patients are currently pregnant, breastfeeding or planning a pregnancy; 12.Have a history of infectious diseases such as hepatitis B (HBs-Ag), hepatitis C (HCV-Ab), pulmonary tuberculosis or sexually transmitted active diseases such as HIV and syphilis; 13.Have a history of using anti-NASH drugs (vitamin E, ursodeoxycholic acid, s-Adenosylmethionine, betaine, silymarin, gemdibrozil, anti-TNF therapy, probiotics, ect.) within 3 months before random grouping; 14.Having structural and functional genitourinary abnormalities prone to cause genitourinary infection; 15.Patients with abnormal hematologic system or any diseases that may cause hemolysis or unstable erythrocyte; 16.Have a history of using immunomodulators, such as biological agents, cyclophosphamide, cyclosporine, etc.; 17.Patients with MRI incompatible metal or magnetic implant, device or materials.

Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye

NCT02846571
Recruiting
Conditions Diabetes
Phase PHASE1, PHASE2
Enrollment 2
Locations 2 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The intervention in this trial is intraocular islet transplantation. A single dose of 1000 - 3000 Islet Equivalents (IEQ)/kg recipient body weight (BW) will be infused into the anterior chamber of the eye through a self-sealing incision in the peripheral cornea. The procedure is projected to take approximately 20-30 minutes. Transplant recipients in this study will receive localized maintenance immunosuppression via topical application of eye-drops.

Design

Study type: Interventional Phases: Phase1, Phase2 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Biological: Human Pancreatic Islet Transplantation — Human pancreatic islet transplantation in the eye anterior chamber of legally blind type 1 or type 2 diabetes patients with and without insulin-dependence

Primary Outcomes

  • Absence of ocular complications (24 months after transplant)
  • Absence of sympathetic ophthalmia (24 months after transplant)
  • Confirmation of intraocular islet graft survival (24 months after transplant)
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: PHASE1, PHASE2
Status: Recruiting
Start Date: 2019-12-05
Completion: 2027-12-31
Eligibility
Age: 18 Years – 75 Years
Sex: ALL
Volunteers: false
Enrollment: 2 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Midhat H. Abdulreda
Collaborators: Diabetes Research Institute Foundation, Bascom Palmer Eye Institute
Principal Investigators:
  • Midhat H Abdulreda, Ph.D. (PRINCIPAL_INVESTIGATOR) - University of Miami
Contact Information
Study Contact:
Midhat H Abdulreda, Ph.D.
305-243-9871
mabdulreda@miami.edu
Sonia Yoo, M.D.
305-326-6000
syoo@med.miami.edu
Sonia H. Yoo, M.D.
305-326-6000
syoo@med.miami.edu
Bascom Palmer Eye Institute
Interventions
  • Biological: Human Pancreatic Islet Transplantation — Human pancreatic islet transplantation in the eye anterior chamber of legally blind type 1 or type 2 diabetes patients with and without insulin-dependence
Study Locations (2 sites)
Bascom Palmer Eye Institute, Miami, Florida 33136 United States
Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, Florida 33136 United States
Eligibility Criteria
Patients who meet all of the following criteria are eligible for participation in the study: Ophthalmic inclusion criteria: 1. Patient with at least one eye with extensive loss of vision from hand motion to no light perception. 2. Phakic or pseudophakic with a stable intraocular lens in the blind eye. 3. Normal cornea with good visualization of the anterior segment. 4. Normal anterior segment anatomy including the iris bed. General and metabolic inclusion criteria: 1. Male and female subjects ages 18 to 75 years of age and no history of non-compliance. 2. Clinical history compatible with T1D or T2D with or without insulin-dependence at the time of enrollment. 3. Stable renal function of native or transplanted kidney if applicable. 4. Ability to provide written informed consent. 5. Mentally stable and able to comply with the procedures of the study protocol. Exclusion Criteria: Patients who meet any of these criteria are not eligible for participation in the study: Ophthalmic exclusion criteria (only in surgical eye): 1. Poor visualization of the anterior chamber (corneal opacity, corneal edema, Herpes Keratitis). 2. Aphakic status (no lens). 3. Narrow angle of iris anatomy: Spade Scale IV. 4. History of uncontrolled glaucoma or glaucoma that had required surgical intervention (e.g., trabeculectomy or shunting devices). 5. Active uncontrolled uveitis. 6. Presence of silicone in the anterior segment after complex diabetic retinopathy surgery. 7. History of allergy to topical steroids and immune-modulatory drugs including CSA and Tacrolimus. General and metabolic exclusion criteria: 1. HbA1c \>10%. 2. Blood Pressure: SBP \>160 mmHg or DBP \>100 mmHg. 3. Calculated GFR of ≤40 mL/min/1.73 m2 for patients with kidney transplant or \<80 mL/min/1.73 m2 for those without kidney transplant, using the subject's measured serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation1. 4. Strict vegetarians (vegans) will be excluded only if their estimated GFR is ≤35 mL/min/1.73 m2 for patients with kidney transplant or \<70 mL/min/1.73 m2 for those without kidney transplant. 5. Proteinuria (albumin/creatinine ratio or ACr \>300mg/dl) of new onset or since kidney transplantation if applicable. 6. Calculated panel-reactive anti-HLA antibodies \>20%. 7. Positive crossmatch. 8. Antibodies (i.e., presumed de-novo) to the kidney transplant donor, if applicable. 9. For female subjects: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. For male subjects: intent to procreate during the duration of the study (24 months) or within 4 months after discontinuation, or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable. 10. Presence or history of active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB). Subjects with laboratory evidence of active infection are excluded even in the absence of clinical evidence of active infection. 11. Negative screen for Epstein-Barr Virus (EBV) by IgG determination. 12. Invasive aspergillus, histoplasmosis, and coccidioidomycosis infection within one year prior to study enrollment. 13. Active malignancy (cancer) except if successfully treated and declared cancer-free and/or in-remission by the oncologist. 14. Known active alcohol or substance abuse. 15. Baseline Hb below the lower limits of normal at the local laboratory; lymphopenia (\<1,000/µL), neutropenia (\<1,500/µL), or thrombocytopenia (platelets \<100,000/µL). Participants with lymphopenia are allowed if the investigator determines there is no additional risk with additional clearance from a hematologist. 16. Severe co-existing cardiac disease, characterized by any one of these conditions: 1. Recent myocardial infarction (within past 6 months). 2. Evidence of ischemia on functional cardiac exam within the last year. 3. Left ventricular ejection fraction \<30%. 17. Hyperlipidemia despite medical therapy (fasting low-density lipoprotein \[LDL\] cholesterol \>130 mg/dL, treated or untreated; and/or fasting triglycerides \>200 mg/dL) for patients with kidney transplant. 18. Receiving treatment for a medical condition requiring chronic use of systemic steroids, except for the use of ≤5 mg prednisone daily, or an equivalent dose of hydrocortisone, for physiological replacement only. 19. Use of any investigational agents within 4 weeks of enrollment. 20. Administration of live attenuated vaccine(s) within 2 months of enrollment. 21. Any medical condition that, in the opinion of the investigator, will interfere with the safe participation in the trial.

Circadian Intervention to Improve Cardiometabolic Health

NCT05943626
Recruiting
Conditions Cardiometabolic Syndrome, Type 2 Diabete...
Phase NA
Enrollment 20
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-12
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The overall goal is to examine the efficacy of a circadian intervention in people with overweight and obesity and habitual short sleep duration (HSSD). Participants will undergo a randomized controlled trial, with circadian intervention and control (healthy lifestyle) groups. The circadian intervention is designed to reduce nighttime light exposure and after-dinner snack food intake. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).

Design

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

Interventions / Regimen

  • Behavioral: Circadian Intervention — The circadian intervention group will receive counseling and instruction to reduce evening and nighttime light exposure, increase morning room light and sunlight exposure, and to finish all food consumption at least 4 hours before bedtime.

Primary Outcomes

  • Insulin sensitivity change from baseline (Change from baseline to end of the ~8 week experimental segment)
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: Recruiting
Start Date: 2023-06-13
Completion: 2027-06
Eligibility
Age: 18 Years – 45 Years
Sex: ALL
Volunteers: true
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Utah
Contact Information
Study Contact:
Christopher M Depner, PhD
801-581-2275
christopher.depner@utah.edu
Christopher Depner
8015812275
sleepstudyparticipant@utah.edu
College of Health Research Complex--University of Utah
Interventions
  • Behavioral: Circadian Intervention — The circadian intervention group will receive counseling and instruction to reduce evening and nighttime light exposure, increase morning room light and sunlight exposure, and to finish all food consumption at least 4 hours before bedtime.
Study Locations (1 sites)
College of Health Research Complex--University of Utah, Salt Lake City, Utah 84112 United States
Eligibility Criteria
Inclusion Criteria: 1. Age: 18-45 years old; equal numbers of men and women 2. Body mass index (BMI): 25.0-34.9 kg/m2, 3. Sleep Habits: habitual self-reported average total sleep time (TST) \<6.5 hours per night for prior 6 months Exclusion Criteria: 1. Clinically diagnosed sleep disorder or major psychiatric illness 2. Evidence of significant organ dysfunction or disease (e.g., diagnosed diabetes, cardiovascular disease, or kidney disease) 3. Use of prescription drugs or substances known to influence sleep or glucose metabolism 4. Shift-work: current or history of within last year 5. Weight change: \>10% of body weight over prior six months 6. Experiencing menopause or post-menopausal 7. Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program 8. Currently pregnant or planning to become pregnant, or currently lactating. 9. Currently smoking 10. Alcohol intake \>3 drinks per day or \>14 drinks per week

AeviceMD for Detection of Wheeze in Pediatric and Adult Populations

NCT06691971
Recruiting
Conditions Subject Presenting Wheeze, Asthma, Bronc...
Phase Not Applicable
Enrollment 160
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-10
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

Respiratory signs and symptoms consisting of wheeze, cough, and breathlessness are obtained in a manual fashion through history taking and physical examination by the healthcare professional. Auscultation of the lung assesses airflow through the trachea-bronchial tree and is helpful in diagnosing various respiratory disorders. AeviceMD is a wearable device that can acquire and process lung sounds, thus assisting in the detection of abnormal lung sounds. The primary objective of this study is to determine if AeviceMD can detect wheeze of pediatrics and adults as accurately as a physician through auscultation. The secondary objective is to investigate if AeviceMD can be used for remote auscultation of breath sounds.

Design

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

Interventions / Regimen

  • Device: AeviceMD — The AeviceMD device will be placed on the patient to detect the presence of wheeze and perform auscultation.

Primary Outcomes

  • Wheeze is detected by physician and AeviceMD (60 Seconds)
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: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2023-06-29
Completion: 2026-12
Eligibility
Age: 3 Years and older
Sex: ALL
Volunteers: false
Enrollment: 160 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Aevice Health Pte. Ltd.
Collaborators: Montefiore Medical Center
Contact Information
Study Contact:
Sunit P. Jariwala, Professor, M.D.
718-920-6089
sjariwal@montefiore.org
Carlos L. Lutz, Assistant Professor, M.D.
718-920-6626
clutz@montefiore.org
Sunit P. Jariwala, Professor
718-920-6089
sjariwal@montefiore.org
Montefiore Medical Center
Interventions
  • Device: AeviceMD — The AeviceMD device will be placed on the patient to detect the presence of wheeze and perform auscultation.
Study Locations (1 sites)
Montefiore Medical Center, The Bronx, New York 10467 United States
Eligibility Criteria
Inclusion Criteria: * The subject is willing and/or parents/guardians are able to give informed consent for participation in the study. * Male or Female, aged ≥ 3 years. * Diagnosed with acute asthma exacerbation by an ED provider. Exclusion Criteria: * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subjects at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study.