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Showing 20 of 27881 trials
Efficacy of Lactobacillus Paracasei LC19 on Type 2 Diabetes
NCT06639425
Recruiting
Conditions Type 2 Diabetes
Phase NA
Enrollment 60
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This is a randomized, double-blind, placebo-controlled clinical trial. The objective of this trial is to determine whether Lactobacillus paracasei LC19 supplementation has a positive effect on glucose lowering in patients with type 2 diabetes (T2D).

Design

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

Interventions / Regimen

  • Dietary Supplement: Lactobacillus paracasei LC19 supplementation — Orally administered Lactobacillus paracasei LC19 strain product, in addition to lifestyle intervention. This product is a probiotic milk powder, and the Lactobacillus paracasei LC19 strain is capable of producing high levels of tryptophan-conjugated cholic acid (Trp-CA)( 25g/packet, 2 packets/day).
  • Dietary Supplement: Placebo probiotic milk powder — Orally administered placebo probiotic milk powder, in addition to lifestyle intervention. The placebo probiotic strain also belongs to Lactobacillus paracasei species, but does not produce Trp-CA. These products have the same color, odor, appearance, and packaging (25g/packet, 2 packets/day).

Primary Outcomes

  • HbA1c change (From enrollment to the end of treatment at 12 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-10-12
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Beijing Chao Yang Hospital
Principal Investigators:
  • Guang Wang, MD (PRINCIPAL_INVESTIGATOR) - Beijing Chao Yang Hospital
Contact Information
Study Contact:
Jia Liu, MD
010-85231710
liujia0116@126.com
Xiaoyu Ding, MD
010-85231711
dxycy0828@163.com
Interventions
  • Dietary Supplement: Lactobacillus paracasei LC19 supplementation — Orally administered Lactobacillus paracasei LC19 strain product, in addition to lifestyle intervention. This product is a probiotic milk powder, and the Lactobacillus paracasei LC19 strain is capable of producing high levels of tryptophan-conjugated cholic acid (Trp-CA)( 25g/packet, 2 packets/day).
  • Dietary Supplement: Placebo probiotic milk powder — Orally administered placebo probiotic milk powder, in addition to lifestyle intervention. The placebo probiotic strain also belongs to Lactobacillus paracasei species, but does not produce Trp-CA. These products have the same color, odor, appearance, and packaging (25g/packet, 2 packets/day).
Study Locations (1 sites)
Beijing Chao-yang Hospital, Capital Medical University, Beijing, Beijing Municipality 100020 China
Eligibility Criteria
Inclusion Criteria: * Age 18-65 years, both genders eligible * Drug-naive patients with newly diagnosed type 2 diabetes * Subjects with screening HbA1c ≥ 7.0% and ≤ 9.0% * Subjects understand the nature, significance, potential benefits, inconvenience, and risks and procedure of the study, and voluntarily sign the informed consent form Exclusion Criteria: * Other types of diabetes except T2D: type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes, or secondary diabetes (such as acromegaly or Cushing\'s syndrome, etc.) * Subjects with acute diabetic complications such as diabetic ketoacidosis or diabetic hyperosmolar coma in the past 6 months * Subjects with history of hypoglycemia in the past 6 months * Subjects with history of New York Heart Association class (NYHA) grade of heart function ≥ III or serious cardiovascular diseases (myocardial infarction, or with the history of cardiac interventional therapy or stent implantation, valve disease or valve repair, unstable angina, transient ischemic attack or stroke) within 6 months before the screening period * Subjects with history of chronic active hepatitis and/or severe liver dysfunction, renal dysfunction, and thyroid dysfunction * Subjects with a medical history of malignant tumor * Subjects with history of gastrointestinal diseases that affect food digestion and absorption (such as severe diarrhea, constipation, irritable bowel syndrome, inflammatory bowel disease, active gastrointestinal ulcers, acute cholecystitis, etc.) or with a history of intestinal resection or other gastrointestinal surgery (such as cholecystectomy) within one year before the screening period * Subjects with history of surgery, or severe trauma in the past 6 months, or planning to undergo surgery during the study period * Subjects suffering from severe infections, severe anemia, or neutropenia * Subjects pregnant or in lactation, or those planning to become pregnant or impregnate during or within 3 months after the study period * Subjects with history of receiving immunosuppressants, steroids, anti diarrheal drugs, antibiotics, lipid-lowering drugs, or other gastrointestinal motility medications within the past 3 months; * Subjects using other medications that can affect blood glucose in the past 3 months * Subjects with consumption of other probiotic or prebiotic products in the past 3 months before secreening * Subjects with lactose intolerance, known or suspected allergy to probiotics used in experiments, history of drug allergies or allergic diseases * Subjects with weight fluctuations ≥ 5kg in the past 3 months or planning to take medication to control weight during the study period * Subjects with history of mental illness or epilepsy, or taking antidepressant medications * Subjects with history of alcohol abuse (for men, alcohol consumption exceeding 40 grams per day and for women, exceeding 20 grams per day) * Subjects have participated in any other clinical study in the past 3 months
Specificities of Atypical Non AutoImmune Diabetes (ANAID) in the French West Indies
NCT07576374
Not yet recruiting
Conditions Metabolic Diseases, Diabetes Mellitus (T...
Phase Not Applicable
Enrollment 118
Locations 1 sites
Compensation compensation available
Data Updated 2026-07-30
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Study Details Design, interventions, and primary outcomes

About This Study

Genetics variants could be involved in atypical non-autoimmune diabetes revealed by ketoacidosis. The objective of this research will be to determine the relationships between the genetic variants already described in known monogenic diabetes or identified as involved in glucose metabolism and its regulation, in insulin signaling pathways or in insulin secretion itself in subjects of African and Indian ancestry with atypical forms of non autoimmune diabetes.

Design

Study type: Observational Observational model: Case Only Time perspective: Prospective

Primary Outcomes

  • known pathogenic mutations described in monogenic diabetes of the MODY type (At inclusion)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2026-06
Completion: 2029-09
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 118 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Centre Hospitalier Universitaire de la Guadeloupe
Principal Investigators:
  • Fritz-Line VELAYOUDOM, Doctor (PRINCIPAL_INVESTIGATOR) - CHU de la Guadeloupe
Contact Information
Study Contact:
Fritz-Line VELAYOUDOM, Doctor
0590 89 13 00
fritz-line.velayoudom@chu-guadeloupe.fr
Interventions
N/A
Study Locations (1 sites)
Centre Hospitalier Universitaire de la Guadeloupe, Les Abymes, Guadeloupe 97159 Guadeloupe
Eligibility Criteria
Inclusion Criteria: Phenotypic criteria : Subjects from Indian or African Ancestry self-declared Age criteria at diagnosis: Early onset of diabetes: patient aged between 18 and 47 years at the time of diagnosis of diabetes Clinical criteria: at least 2 criteria Labeled type 2 diabetic Patient hospitalized for: Ketoacid decompensation Significant weight loss (more than 10% in less than 6 months) without obvious etiology Lipodystrophic / lipoatrophic appearance Presence of an associated myopathy or deafness Presence of early inaugural nephropathy or within 3 years after diagnosis Presence of early inaugural heart disease or within 3 years after diagnosis Poor response to non-insulin treatments despite good adherence Biological criteria: Absent T1D autoantibodies: Anti-islet antibodies (ICA) Anti-IA2 antibodies Anti-insulin antibodies Anti-ZnT8 antibodies Anti-GAD antibodies Other criteria: Informed consent signed by the patient Exclusion Criteria: Type 1 diabetes (T1D) Presence of T1D antibodies Secondary diabetes (pancreas diseases, endocrine diseases, drug intake, infection) Other associated autoimmune pathologies Pregnancy Refusal to participate
Innovative Approaches in Diabetes Care
NCT05687968
Recruiting
Conditions Type 2 Diabetes, AI-supported Real-time ...
Phase NA
Enrollment 39
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
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Study Details Design, interventions, and primary outcomes

About This Study

In Taiwan, an estimated 2.3 million individuals have diabetes, with a 44% increase observed among young adults and adolescents. Poor dietary habits and sedentary lifestyles are major risk factors for type 2 diabetes. The widespread use of smartphones has facilitated the development of digital health technologies, including digital food photography and artificial intelligence (AI), which show promise for personalized nutrition care and health promotion. While such technologies have demonstrated short-term success in diabetes management, their long-term effectiveness remains uncertain. This study aims to evaluate the effectiveness of a digital eHealth care intervention for individuals with diabetes. Participants will be recruited from the Diabetes Shared Care Network and community care centers in Taiwan and followed for 12 months. Eligible participants will be randomly assigned by computer to either a control or an eHealth care group. • eHealth Group: Receives a 10-minute digital nutrition education session using the lab-developed "3D/AR MetaFood food portion education platform" (https://sketchfab.com/susanlab108/collections) and is required to submit weekly dietary records through food images using the "Formosa FoodAPP." Participants will receive immediate dietary feedback from nutritionists, followed by AI-generated personalized feedback on the glycemic index (GI) and glycemic load (GL) of their meals. They will also be provided with educational videos on healthy eating, physical activity, and selecting low-GI/GL foods. Anthropometric measurements and baseline questionnaires will be collected at enrollment. Blood biochemistry, including HbA1c, will be measured at baseline, and at 3, 6, 9, and 12 months. Collected food image data will be used to train AI systems for real-time dietary feedback and to explore the relationship between nutrient intake and long-term glycemic control.

Design

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

Interventions / Regimen

  • Behavioral: Real-Time Personalized Dietary Feedback (via AI and Nutritionist) — * Behavioral: "3D/AR MetaFood" Portion Size and Nutrition Education * Behavioral: Nutrition and Physical Activity Educational Videos
  • Behavioral: conventional nutrition education by dietitian — The participants receive conventional health and nutrition education from state registered dietitian.

Primary Outcomes

  • HbA1c (baseline, 3 month, 6 month, 9 month, 12 month)
  • Fasting glucose (baseline, 3 month, 6 month, 9 month, 12 month)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2022-10-19
Completion: 2025-10-01
Eligibility
Age: 20 Years
Sex: ALL
Volunteers: false
Enrollment: 39 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Taipei Medical University
Principal Investigators:
  • Jung-Su Chang, PhD. (PRINCIPAL_INVESTIGATOR) - College of Nutrition, Taipei Medical University
Contact Information
Study Contact:
Jung-Su Chang, PhD.
886-66382736
susanchang@tmu.edu.tw
Interventions
  • Behavioral: Real-Time Personalized Dietary Feedback (via AI and Nutritionist) — * Behavioral: "3D/AR MetaFood" Portion Size and Nutrition Education * Behavioral: Nutrition and Physical Activity Educational Videos
  • Behavioral: conventional nutrition education by dietitian — The participants receive conventional health and nutrition education from state registered dietitian.
Study Locations (1 sites)
Jung-Su Chang, Taipei, 110 Taiwan
Eligibility Criteria
Inclusion Criteria: 1. 20 years old or older 2. Pre-diabetes or diabetes 3. Taiwan nationality or fluent in Mandarin or Taiwanese 4. Not pregnant or breastfeeding 5. Capable (or assisted by a caregiver) of using a smartphone to photograph and record meals Exclusion Criteria: 1. Eating disorders 2. Undergoing treatment for severe illnesses that could affect normal dietary intake (e.g., cancer) 3. Unable to use a smartphone to take photos and record food intake.
Balance Control and Recovery in Diabetes Peripheral Neuropathy
NCT06544876
Recruiting
Conditions Diabetic Peripheral Neuropathy, Diabetic...
Phase NA
Enrollment 60
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
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Study Details Design, interventions, and primary outcomes

About This Study

In this study the effects of diabetic peripheral neuropathy will be assessed on balance control, balance recovery, and muscle electrical activity in adults over 50 years. Aim 1: Determine muscle activity and balance control during a sit-to-stand in adults age above 50 with and without diabetic peripheral neuropathy. Aim 2: Assess local balance recovery and latency responses to lateral surface perturbation during quiet standing.

Design

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

Interventions / Regimen

  • Behavioral: sit-to-stand — test for balance during movement from sitting to standing
  • Behavioral: stand to sit — test for balance during movement from standing to sitting
  • Behavioral: standing perturbation — test for balance recovery following perturbation
  • Other: MRI of sciatic nerve — measure of peripheral nerve diameter

Primary Outcomes

  • Center of pressure using force plate (First session (immediately after intervention))
  • Center of mass using Vicon cameras. (First session (immediately after intervention))
  • Joint moment using Nexus software (First session (immediately after intervention))
  • Local dynamic stability using Motek and Vicon system (First session (immediately after intervention))
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-09-12
Completion: 2028-08-31
Eligibility
Age: 50 Years
Sex: ALL
Volunteers: true
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Lisa Griffin
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Behavioral: sit-to-stand — test for balance during movement from sitting to standing
  • Behavioral: stand to sit — test for balance during movement from standing to sitting
  • Behavioral: standing perturbation — test for balance recovery following perturbation
  • Other: MRI of sciatic nerve — measure of peripheral nerve diameter
Study Locations (1 sites)
The University of Texas at Austin, Austin, Texas 78712 United States
Eligibility Criteria
Inclusion Criteria: * Type II diabetes with peripheral neuropathy Exclusion Criteria: * Foot ulcer * Partial amputation * Have experience of Stroke * Painful neuropathy * Inability to stand or walk independently
A Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets in Participants With Type 2 Diabetes Mellitus
NCT07321678
Active, positions filled
Conditions T2DM (Type 2 Diabetes Mellitus)
Phase PHASE2
Enrollment 100
Locations 8 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This randomized, double-blind, placebo-controlled Phase II study is designed to evaluate the efficacy, safety, and tolerability of ASC30 oral tablets formulation in participants with Type 2 Diabetes Mellitus

Design

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

Interventions / Regimen

  • Drug: ASC30 tablets — ASC30 tablets administered orally once daily
  • Drug: Placebo — Placebo administered orally once daily

Primary Outcomes

  • Mean change from baseline in HbA1c up to 13 weeks in the treatment group compared with the placebo group (Baseline and end of Week 13)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2026-01-22
Completion: 2026-08
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Ascletis Pharma (China) Co., Limited
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: ASC30 tablets — ASC30 tablets administered orally once daily
  • Drug: Placebo — Placebo administered orally once daily
Study Locations (8 sites)
Ascletis Clinical Site, Riverside, California 92506 United States
Ascletis Clinical Site, San Jose, California 95128 United States
Ascletis Clinical Site, Denver, Colorado 80246 United States
Ascletis Clinical Site, Miami, Florida 33143 United States
Ascletis Clinical Site, Miami, Florida 33172 United States
Ascletis Clinical Site, Decatur, Georgia 30030 United States
Ascletis Clinical Site, Springfield, Missouri 65802 United States
Ascletis Clinical Site, San Antonio, Texas 78240 United States
Eligibility Criteria
Inclusion Criteria: * Have Type 2 Diabetes (T2D) * Have HbA1c ≥7.0% to ≤10.5% as determined by the central laboratory at screening. * Stable body weight (less than 5% self-reported change within the previous 3 months). * Have a BMI ≥23.0 kilogram/square meter (kg/m²) at screening. Exclusion Criteria: * Have any prior diagnosis of type 1 diabetes mellitus (T1DM), or rare forms of diabetes mellitus * Have had more than 1 episode of severe hypoglycemia * Have poorly controlled hypertension * Have acute or chronic hepatitis and pancreatitis * Have evidence of a significant active and uncontrolled medical condition
A Phase 1 Clinical Trial to Assess the Safety of DWRX5003 and Relative Bioavailability to DWC202502 and DWC202503 in Healthy Adult Volunteers
NCT07539415
Recruiting
Conditions Obesity & Overweight, Type 2 Diabetes
Phase PHASE1
Enrollment 72
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Phase 1 Safety and Relative Bioavailability Study of DWRX5003 in Healthy Adults

Design

Study type: Interventional Phases: Phase1 Allocation: Randomized Intervention model: Sequential Primary purpose: Treatment Masking/blinding: Double

Interventions / Regimen

  • Drug: DWRX5003 — Microneedle patch containing Semaglutide
  • Drug: DWC202502 — Semagluide
  • Drug: DWC202503 — Semaglutide
  • Other: DWRX5003P — placebo microneedle patch

Primary Outcomes

  • AUC 0-t (Pre-dose (0 hour) up to 672 hours post-dose)
  • Cmax (Pre-dose (0 hour) up to 672 hours post-dose)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2026-05-06
Completion: 2026-11-17
Eligibility
Age: 19 Years
Sex: ALL
Volunteers: true
Enrollment: 72 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Daewoong Pharmaceutical Co. LTD.
Contact Information
Study Contact:
YeaRa Kwak
+8225508317
yeara.kwak@daewoong.co.kr
Interventions
  • Drug: DWRX5003 — Microneedle patch containing Semaglutide
  • Drug: DWC202502 — Semagluide
  • Drug: DWC202503 — Semaglutide
  • Other: DWRX5003P — placebo microneedle patch
Study Locations (1 sites)
Seoul National University Hospital, Seoul, South Korea
Eligibility Criteria
Inclusion Criteria: 1. Healthy adult volunteers aged ≥ 19 and ≤ 65 years at screening 2. Subjects with a body weight ≥ 50.0 kg to ≤ 100.0 kg and a BMI of ≥ 20.0 kg/m2 to ≤ 29.9 kg/m2 at screening 3. Subjects with no congenital disease or chronic disease requiring treatment as well as no pathologic symptoms or findings based on medical examination 4. Subjects who are determined to be eligible for this study based on results of laboratory tests, vital signs, physical examination, 12-lead electrocardiogram (ECG), etc. set and performed according to the nature of the IP at screening 5. Subjects who voluntarily decided to participate in the study and provided written consent to follow subject compliance requirements during the study after receiving a detailed explanation on this study and fully understanding the information Exclusion Criteria: 1. Subjects with past or current medical history of clinically significant hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematologic, oncologic, genitourinary, cardiovascular, digestive, and musculoskeletal diseases: 2. Females who are pregnant (serum-HCG positive) or breast-feeding 3. Subjects with a history of hypersensitivity (e.g., anaphylaxis or angioedema) or clinically significant hypersensitivity to the active ingredient of the IP, pharmaceutical excipients, or other drugs (e.g., GLP-1 receptor agonists) 4. Subjects with a history of skin disease (e.g., burns, skin cancer, etc.) or skin transplant surgery that could affect the absorption of the investigational product 5. Subjects with a history of acute or chronic pancreatitis 6. Subjects with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2) 7. Subjects who are deemed ineligible for participation in the study by the investigator for reasons other than the above inclusion/exclusion criteria etc.
Mobile Health and Wearable Devices for Diabetes Complication Management
NCT07129148
Recruiting
Conditions Diabetes Mellitus Type 2, Diabetes Melli...
Phase NA
Enrollment 6000
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The value of intelligent lifestyle intervention for T2D and its complications has been initially explored, but evidence-based support for the effectiveness of related AI risk prediction models and intervention models remains to be confirmed. The primary objective of this study is to verify the effectiveness of an AI model for predicting the risk of T2D complications based on phenotype, laboratory indicators and wearable device indicators, and to explore the effect and applicability of an intelligent lifestyle intervention model combining wearable devices and smartphones in preventing T2D complications.

Design

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

Interventions / Regimen

  • Other: Device: No specific devices — Routine doctor-patient interaction.
  • Other: Device: CGM,CGM management platform — Wearable monitoring + CGM management platform-assisted administration
  • Other: Device: "Professor Tang" WeChat Mini-program — Mini-program-assisted health management
  • Other: Device: CGM, Smart Bracelet, "Professor Tang" WeChat Mini-program — Wearable monitoring + mini-program integrated management

Primary Outcomes

  • HbA1c (Baseline, 1 year)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-10-01
Completion: 2027-10-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 6000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Second Xiangya Hospital of Central South University
Collaborators: First Hospital of China Medical University, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Harbin Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, First Affiliated Hospital of Kunming Medical University, Tianjin Medical University, Shanghai 6th People's Hospital, Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus, Sinocare
Contact Information
Study Contact:
HouDe Zhou, Prof.
86-0731-85292223
houdezhou@csu.edu.cn
Interventions
  • Other: Device: No specific devices — Routine doctor-patient interaction.
  • Other: Device: CGM,CGM management platform — Wearable monitoring + CGM management platform-assisted administration
  • Other: Device: "Professor Tang" WeChat Mini-program — Mini-program-assisted health management
  • Other: Device: CGM, Smart Bracelet, "Professor Tang" WeChat Mini-program — Wearable monitoring + mini-program integrated management
Study Locations (1 sites)
Second Xiangya Hospital of Central South University, Changsha, China
Eligibility Criteria
Inclusion Criteria: 1. Confirmed diagnosis of Type 2 Diabetes; 2. Aged ≥ 18 years; 3. Able to accept the diabetes management model with AI-assisted management and wearable device monitoring; 4. Able to provide complete lifestyle records, including medical history, medication status, diet, exercise, etc.; 5. Fully understand the purpose, nature, and methods of the study, voluntarily participate in this study, accept a 3-month follow-up, and sign the informed consent form. Exclusion Criteria: 1. Having severe mental illness or language barriers; 2. Suffering from malignant tumors; 3. Pregnant or lactating women; 4. Suspected active infections (such as active pulmonary tuberculosis, pneumonia, etc.); 5. Severe hepatic and renal insufficiency (alanine transaminase and/or aspartate transaminase \> 3 times the upper limit of normal; estimated glomerular filtration rate \< 15 mL/min/1.73 m²); 6. A history of definite major adverse cardiovascular events and/or revascularization and/or intravenous thrombolysis and/or endovascular thrombectomy; 7. Uncontrolled hyperthyroidism or hypothyroidism, pituitary-adrenal dysfunction, or other endocrine diseases; 8. Alcoholism or drug addiction; 9. Receiving insulin therapy; 10. Unable to accept new comprehensive intervention technologies for various reasons (such as personal beliefs, economic factors, etc.).
Ketogenic Diet and Diabetes Demonstration Project
NCT06115265
Recruiting
Conditions Type 2 Diabetes, PreDiabetes, Obesity, K...
Phase NA
Enrollment 40
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

KDDP is a prospective, 12-month pilot study comparing the effects of a novel lifestyle program, the Ketogenic Diet and Diabetes Demonstration Project (KDDP) to those of the National Diabetes Prevention Program (NDDP). KDDP is modeled to mimic the delivery platform of NDPP with the exception that participants in KDDP will be placed on a medically-supervised ketogenic diet, and participants in NDPP will be placed on a low fat diet. The purpose of this study is to compare the metabolic effects of the KDDP and the NDPP on glycemic control, lipid parameters, blood pressure, heart rate, weight, and coronary artery calcium scores in individuals with either type 2 diabetes or prediabetes.

Design

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

Interventions / Regimen

  • Behavioral: Ketogenic diet — KDDP and NDPP will deliver identical comprehensive lifestyle counseling and follow up to participants, but dietary interventions in each group will differ, with KDDP participants receiving a ketogenic diet and NDPP participants receiving a low fat diet.
  • Behavioral: Low Fat diet — KDDP and NDPP will deliver identical comprehensive lifestyle counseling and follow up to participants, but dietary interventions in each group will differ, with KDDP participants receiving a ketogenic diet and NDPP participants receiving a low fat diet.

Primary Outcomes

  • Weight in kg (12 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-09-05
Completion: 2026-10-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of New Mexico
Principal Investigators:
  • Kristen Gonzales, MD (PRINCIPAL_INVESTIGATOR) - University of New Mexico
Contact Information
Study Contact:
Kristen M Gonzales, MD
505-272-3840
KrGonzales@salud.unm.edu
Matthew Bouchonville, MD
505-272-3840
mbouchonville@salud.unm.edu
Interventions
  • Behavioral: Ketogenic diet — KDDP and NDPP will deliver identical comprehensive lifestyle counseling and follow up to participants, but dietary interventions in each group will differ, with KDDP participants receiving a ketogenic diet and NDPP participants receiving a low fat diet.
  • Behavioral: Low Fat diet — KDDP and NDPP will deliver identical comprehensive lifestyle counseling and follow up to participants, but dietary interventions in each group will differ, with KDDP participants receiving a ketogenic diet and NDPP participants receiving a low fat diet.
Study Locations (1 sites)
University of New Mexico, Albuquerque, New Mexico 87131 United States
Eligibility Criteria
Inclusion Criteria: * Men and women ≥ 18 years old * BMI ≥27 kg/m2 * Hemoglobin A1c ≥ 5.7% and/or fasting plasma glucose of 100-125 mg/dL Exclusion Criteria: * Known clinical cardiovascular disease (i.e. prior stroke, myocardial infarction, peripheral artery disease) * LDL cholesterol ≥ 190 mg/dL * Triglycerides ≥ 500 mg/dL * History of type 1 diabetes * History of diabetic ketoacidosis * Individuals requiring insulin * Advanced renal disease * Advanced liver disease * Terminal cancer * Pregnancy
A Study of Cardiovascular Events iN Diabetes Plus
NCT05441267
Active, positions filled
Conditions Diabetes Mellitus, Type 2
Phase PHASE4
Enrollment 21296
Locations 1 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

ASCEND PLUS is testing whether, for people with type 2 diabetes who have not previously had a heart attack or stroke, regularly taking a tablet called semaglutide can safely help to reduce heart attacks, strokes, mini-strokes, the need for any procedures to unblock or bypass an artery to their heart, and the chance of dying because of vascular problems.

Design

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

Interventions / Regimen

  • Drug: Semaglutide Oral Tablet — Oral semaglutide 14mg daily (option to reduce to 7mg daily)
  • Drug: Placebo oral tablet — Placebo oral semaglutide

Primary Outcomes

  • Time to the first occurrence of a Major Adverse Cardiovascular Events (MACE+) (Scheduled treatment period (anticipated median follow-up period of 5-years))
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Active, positions filled
Start Date: 2023-03-13
Completion: 2048-08-17
Eligibility
Age: 55 Years
Sex: ALL
Volunteers: false
Enrollment: 21296 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: University of Oxford
Collaborators: Novo Nordisk A/S
Principal Investigators:
  • David Preiss (PRINCIPAL_INVESTIGATOR) - University of Oxford
  • Marion Mafham (PRINCIPAL_INVESTIGATOR) - University of Oxford
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Semaglutide Oral Tablet — Oral semaglutide 14mg daily (option to reduce to 7mg daily)
  • Drug: Placebo oral tablet — Placebo oral semaglutide
Study Locations (1 sites)
Clinical Trial Service Unit and Epidemiological Studies Unit, Oxford, United Kingdom
Eligibility Criteria
Inclusion Criteria: * Adults aged at least 55 years at the time of the Screening assessment * Type 2 Diabetes Mellitus (based on self-reported medical history) Exclusion criteria: * Myocardial Infarction * Stroke * Current or planned treatment with a GLP-1 RA * Previous hypersensitivity to or intolerance of GLP-1 RA therapy * Severe hypoglycaemia within the last six months or during run-in * Symptomatic hypoglycaemia within the last month * Currently under consideration to commence insulin * Severe heart failure (NYHA class 4) * Current or planned renal replacement therapy * Unwilling to complete regular follow-up assessments * Ongoing treatment for cancer or diagnosis with cancer (excluding non-melanoma skin cancer) in the last 2 years * Type 1 or other type of diabetes (e.g. MODY) * History of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma * Currently breastfeeding or pregnant, or planning a pregnancy * Any serious illness which is likely to limit survival or active participation for at least 5 years * Current participation in a clinical trial with an unlicensed investigational medicinal product used to treat diabetes * For participants taking thyroxine, lack of agreement to arrange a thyroid function test in the next 3 months and agree to regular testing throughout the trial * Non-adherence to run-in treatment (i.e. reports taking the run-in tablets 'Never' or 'Only occasionally') * Their doctor does not wish them to be randomised
Efficacy and Safety of Triple Therapy With Dulaglutide, SGLT2 Inhibitors, and Finerenone in Chinese Adults With Type 2 Diabetes and Chronic Kidney Disease
NCT07537088
Not yet recruiting
Conditions T2DM (Type 2 Diabetes Mellitus), CKD - C...
Phase PHASE4
Enrollment 468
Locations 0 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-07-30
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Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study is to evaluate whether adding dulaglutide to the combination therapy of Sodium-Glucose Co-Transporter 2 Inhibitors(SGLT2i) and finerenone can provide additional kidney protection and safety for Chinese adults with Type 2 Diabetes Mellitus(T2DM) and Chronic Kidney Disease(CKD). Eligible participants will be adults with T2DM and mild-to-moderate CKD who have been receiving SGLT2 inhibitor plus finerenone for at least 3 months on the basis of maximum tolerated dose of renin-angiotensin system inhibitor (RASi). Participants will be randomly assigned to either continue the original regimen or to receive add-on therapy with dulaglutide.The study will last for 26 weeks, with participants required to attend scheduled visits for efficacy and safety assessments at Week 13 (±1 week) and Week 26 (±1 week, final visit).

Design

Study type: Interventional Phases: Phase4 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Dulaglutide — Dulaglutide 1.5 mg, once weekly
  • Drug: SGLT2i — administered according to prescribing information
  • Drug: Finerenone — administered according to prescribing information

Primary Outcomes

  • Urine Albumin-to-Creatinine Ratio(UACR) (Change in UACR from baseline at Week 26)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Not yet recruiting
Start Date: 2026-05
Completion: 2027-07
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 468 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: First Affiliated Hospital of Wannan Medical College
Contact Information
Study Contact:
Jialin Gao
0553-5739315
gaojialin-ktz@wnmc.edu.cn
Interventions
  • Drug: Dulaglutide — Dulaglutide 1.5 mg, once weekly
  • Drug: SGLT2i — administered according to prescribing information
  • Drug: Finerenone — administered according to prescribing information
Eligibility Criteria
Inclusion Criteria: * 1.Patients aged ≥18 years with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) * 2.Hemoglobin A1c (HbA1c) 7.0%-11% * 3.Urine albumin-to-creatinine ratio (UACR) 300-5000 mg/g * 4.Body mass index (BMI) 21-45 kg/m² * 5.Having received combination therapy with SGLT2 inhibitor and finerenone for 3 months or longer, on the basis of maximum tolerated dose of renin-angiotensin system inhibitor (RASi) * 6.Sign the informed consent, understand the procedures and methods of this trial and willing to strictly comply with the clinical trial protocol Exclusion Criteria: * 1.Pregnant or lactating women, or women of childbearing potential unwilling to use reliable contraception * 2.History of definite contraindications or intolerance to glucagon-like peptide-1 receptor agonists (GLP-1RA), SGLT2 inhibitors, or finerenone * 3.Type 1 diabetes * 4.History of diabetic ketoacidosis (DKA) within the past 6 months * 5.Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² * 6.Hospitalization within 30 days prior to screening for acute coronary syndrome (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery * 7.Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg (mean of three supine measurements) during screening * 8.Symptomatic hypotension and/or systolic blood pressure \<90 mmHg at screening, or patients judged by the investigator to have hypovolemia * 9.Serum potassium \>5.0 mmol/L at screening * 10.Current use or use within 3 months prior to screening of GLP-1 receptor agonists or other mineralocorticoid receptor antagonists (e.g., spironolactone) * 11.Patients receiving or with clear clinical indications requiring systemic immunosuppressive therapy (including but not limited to prednisone, cyclosporine, etc.) for other kidney diseases (e.g., primary or secondary glomerulonephritis, lupus nephritis) * 12.History of recurrent urinary tract or genital infections (as judged by the investigator) * 13.Life expectancy \<1 year at screening * 14.Confirmed malignancy * 15.Participation in another clinical trial within 3 months prior to screening * 16.Any other condition judged by the investigator as unsuitable for participation in this clinical trial.
NT-ProBNP-based Heart Failure Screening and Prevention Trial in Patients With Type 2 Diabetes: STRONG-DM Study
NCT06593327
Recruiting
Conditions Type 2 Diabetes, Diabetic Cardiomyopathy...
Phase NA
Enrollment 300
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

A pragmatic, randomized clinical trial to evaluate the effect of a heart failure (HF) risk assessment and prevention strategy incorporating HF clinical risk scores (WATCH-DM) with cardiac biomarker (NT-proBNP) paired with a clinical decision support tool to implement an intensive prevention strategy among patients with high risk focused on implementation of evidence-based HF preventive therapies.

Design

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

Interventions / Regimen

  • Behavioral: Intensive Prevention Strategy — Providers randomized to the intensive prevention strategy will receive notification about patients with diabetes who have high heart failure risk and recommendations for medical management, e-consultation, or referral to a cardiometabolic risk management program.

Primary Outcomes

  • Incident Heart Failure or All-cause death (2-year follow-up)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-02-10
Completion: 2027-12-15
Eligibility
Age: No restriction
Sex: ALL
Volunteers: false
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Texas Southwestern Medical Center
Collaborators: Roche Diagnostics GmbH
Contact Information
Study Contact:
Ambarish Pandey, MD
617-869-8957
ambarish.pandey@utsouthwestern.edu
VINAYAK SUBRAMANIAN, MD
2114-645-9868
Interventions
  • Behavioral: Intensive Prevention Strategy — Providers randomized to the intensive prevention strategy will receive notification about patients with diabetes who have high heart failure risk and recommendations for medical management, e-consultation, or referral to a cardiometabolic risk management program.
Study Locations (1 sites)
University of Texas Southwestern Medical Center, Dallas, Texas 75209 United States
Eligibility Criteria
Inclusion Criteria: * Primary Care Provider that sees diabetes patients in clinic Exclusion Criteria: * Provider does not see patients with Diabetes
A Study to Evaluate the Effect of Retatrutide on Insulin Secretion and Insulin Sensitivity in Adult Participants With Type 2 Diabetes Mellitus
NCT06982859
Active, positions filled
Conditions Diabetes Mellitus, Insulin Sensitivity
Phase PHASE1
Enrollment 95
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The primary objective of Study GZQG is to compare the effect of retatrutide and placebo on total clamp disposition index (cDI) after 28 weeks of treatment.

Design

Study type: Interventional Phases: Phase1 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Double

Interventions / Regimen

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

Primary Outcomes

  • Change from Baseline in Total Clamp Disposition Index (cDI) for Comparison of Retatrutide With Placebo (Baseline, Week 28)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Active, positions filled
Start Date: 2025-06-02
Completion: 2026-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 95 (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 8 AM - 8 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
  • Drug: Placebo — Administered SC
Study Locations (1 sites)
Profil Institut für Stoffwechselforschung, Neuss, 41460 Germany
Eligibility Criteria
Inclusion Criteria: * Have been diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 6 months prior to screening. * Treated with diet and exercise and metformin daily, with or without other allowed oral antihyperglycaemia medications (OAMs), 3 months prior to screening. Allowed OAMs are dipeptidyl peptidase-4 inhibitors (DPP-IV) inhibitors, sodium/glucose cotransporter 2 (SGLT2) inhibitors, glinides, and sulfonylureas. * Have a HbA1c value at screening of: * 6.5% and ≤ 9.5 % if on metformin with or without SGLT2 inhibitors, or * 6% and ≤8.5% if on metformin in combination with allowed OAMs that require washout. * Have venous access sufficient to allow for blood sampling as per the protocol. * Have clinical laboratory test results within normal reference range for the population or investigative site or results with acceptable deviations that are judged to be not clinically significant by the investigator. * Have a body mass index (BMI) between 25 kilograms per meter squared (kg/m²) and 45 kg/m², both inclusive, at screening. * Have had a stable body weight that is less than 5% change during the 3-month period prior to screening. Exclusion Criteria: * Have Type 1 Diabetes Mellitus (T1DM) * Have had more than 1 episode of severe hypoglycaemia, as defined by the American Diabetes Association criteria, within 6 months before screening or a history of hypoglycaemia unawareness or poor recognition of hypoglycaemic symptoms; any participant that cannot communicate an understanding of hypoglycaemic symptoms and the appropriate treatment of hypoglycaemia prior to the first dose of study drug should also be excluded. * Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalisation within the 6 months prior to screening. * Are currently receiving, planning to receive, or in need of treatment, that is, intravitreal injections of Vascular Endothelial Growth Factor inhibitor or corticosteroids, focal/grid macular laser surgery, panretinal photocoagulation, or vitrectomy for diabetic retinopathy at screening. * Have impaired renal estimated glomerular filtration rate \<60.0 mL/min/1.73 m² calculated by Chronic Kidney Disease-Epidemiology (2021). * Have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis. * Have elevations in: * serum aspartate aminotransferase (AST) \>2.5X the upper limit of normal (ULN) * serum alanine aminotransferase (ALT) \>2.5X ULN * total bilirubin level (TBL) \>1.5X ULN (except, participants with Gilbert's syndrome), or * Alkaline phosphatase (ALP) level ≥1.5X ULN * Show evidence of possible chronic or active hepatitis B, including hepatitis B core antibody and/or hepatitis B surface antigen positivity. * Have a positive Hepatitis C virus (HCV) antibody (Ab) test. Participants with a positive HCV Ab test at screening can be included only if a confirmatory HCV ribonucleic acid (RNA) test is negative. * Have a known clinically significant gastric emptying abnormality, have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery or chronically take drugs that directly affect GI motility. * Have had within 3 months prior to screening: * acute myocardial infarction * congestive heart failure New York Heart Association (NYHA) class III or IV, and/or * cerebrovascular accident \[stroke\] * coronary artery revascularisation * hospitalization hospitalisation for unstable angina * hospitalization hospitalisation due to congestive heart failure. * Have a history of additional risk factors for Torsades de Pointes (for example, heart failure, hypokalaemia, family history of Long QT Syndrome), as judged by the investigator. * Have a 12-lead ECG abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound electrocardiogram (ECG) data analysis. * Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome Type 2 (MEN 2). * Have an active or untreated malignancy or have been in remission from a clinically significant malignancy for \<5 years prior to screening. Exceptions: * basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years * cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline, or * in situ prostate cancer. * Have, in the opinion of the investigator, evidence of significant, uncontrolled endocrine abnormality, for example, thyrotoxicosis or adrenal crisis. * Have a prior or planned surgical treatment for obesity. * Have a prior or planned endoscopic and/or device-based therapy for obesity. * Have taken any glucose-lowering medications other than metformin, DPP IV inhibitors, sulfonylureas and/or SGLT-2 inhibitors, regardless of the indication for use, any time within the 3 months prior to screening. * Have taken prescribed or over-the-counter (OTC) medications, either approved or unapproved, or alternative remedies, including herbal or nutritional supplements, intended to promote body weight reduction, within 3 months prior to screening. * Have evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies. * Have a calcitonin level at screening of ≥35.0 nanograms per liter (ng/L), \[≥35.0 picograms per milliliter (pg/mL)\].
Primary and Secondary Prevention of Type 2 Diabetes Mellitus in Clark County
NCT06387797
Active, positions filled
Conditions At Risk for Type 2 Diabetes Mellitus, Pr...
Phase NA
Enrollment 120
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This pilot and feasibility study aims to assess the effectiveness of a nutrition education intervention using the Cooking Matters for Adults Curriculum (SNAP-Ed). The study compares this standard curriculum with an enhanced version that includes the same curriculum but has additional components, incorporating specific information related to type 2 diabetes. Additionally, participants in the enhanced group will receive continuous glucose monitors to wear during the study for 10 days. The primary outcomes of the study include evaluating the acceptability of the intervention, and the feasibility of conducting the intervention at the UNLV Nutrition Center. The investigators will also assess participants' Knowledge, Attitudes, and Intentions regarding produce consumption. Alongside feasibility and acceptability, the study aims to explore the preliminary effectiveness of the intervention in increasing fruit and vegetable consumption, reducing HbA1c, managing cardiometabolic risk, and improving gut microbiome composition and diversity among participants in the program. The investigators will also assess changes in other lifestyle behaviors from baseline to post-intervention (6 weeks) (sleep, stress, physical activity, and sedentary behavior).

Design

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

Interventions / Regimen

  • Behavioral: Cooking Matters for Adults (CMA+) — Six cooking classes + enhanced elements, such as diabetes-specific nutrition and cooking information, and online educational information as well as short assignments and activities regarding sleep, stress, physical activity, and sedentary behaviors. This arm will have the opportunity to use a continuous glucose monitor (CGM) for 10 days immediately following the baseline assessment. Each week, participants will collect their own fecal samples in the privacy of their own homes and will return them at their next cooking class. They will also complete a final fecal sample before the follow-up. Finally, 6-weeks after completion of the cooking classes, researchers will follow up via phone, email, or Zoom (participants will provide their preferred method of contact) to complete follow-up assessments of current lifestyle practices and barriers to fruit and vegetable consumption.
  • Behavioral: Cooking Matters for Adults (CMA) — Participants will attend cooking and educational sessions once per week for 6 weeks. In addition, they will receive recipes and produce boxes with instructions to prepare the recipe at some point prior to their next class. They will also be invited to the online Google Classroom site where all intervention materials will be housed for their convenience. Each week, participants will collect their own fecal samples in the privacy of their own homes and will return them at their next cooking class. They will also complete a final fecal sample before the follow-up (kits provided at the final cooking class, for a total of 6 fecal samples per participant). Finally, 6-weeks after completion of the cooking classes, researchers will follow up via phone, email, or Zoom (participants will provide their preferred method of contact) to complete follow-up assessments of current lifestyle practices and barriers to fruit and vegetable consumption.

Primary Outcomes

  • Feasibility of conducting the intervention (At one year)
  • Acceptability of the intervention (At 6-weeks)
  • Acceptability of each cooking class (week 1, week 2, week 3, week 4, week 5, and week 6)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2024-10-01
Completion: 2026-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Nevada, Las Vegas
Collaborators: University of Nevada, Reno
Principal Investigators:
  • Sara K Rosenkranz, PhD (PRINCIPAL_INVESTIGATOR) - University of Nevada, Las Vegas
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Behavioral: Cooking Matters for Adults (CMA+) — Six cooking classes + enhanced elements, such as diabetes-specific nutrition and cooking information, and online educational information as well as short assignments and activities regarding sleep, stress, physical activity, and sedentary behaviors. This arm will have the opportunity to use a continuous glucose monitor (CGM) for 10 days immediately following the baseline assessment. Each week, participants will collect their own fecal samples in the privacy of their own homes and will return them at their next cooking class. They will also complete a final fecal sample before the follow-up. Finally, 6-weeks after completion of the cooking classes, researchers will follow up via phone, email, or Zoom (participants will provide their preferred method of contact) to complete follow-up assessments of current lifestyle practices and barriers to fruit and vegetable consumption.
  • Behavioral: Cooking Matters for Adults (CMA) — Participants will attend cooking and educational sessions once per week for 6 weeks. In addition, they will receive recipes and produce boxes with instructions to prepare the recipe at some point prior to their next class. They will also be invited to the online Google Classroom site where all intervention materials will be housed for their convenience. Each week, participants will collect their own fecal samples in the privacy of their own homes and will return them at their next cooking class. They will also complete a final fecal sample before the follow-up (kits provided at the final cooking class, for a total of 6 fecal samples per participant). Finally, 6-weeks after completion of the cooking classes, researchers will follow up via phone, email, or Zoom (participants will provide their preferred method of contact) to complete follow-up assessments of current lifestyle practices and barriers to fruit and vegetable consumption.
Study Locations (1 sites)
University of Nevada, Las Vegas, Las Vegas, Nevada 89154 United States
Eligibility Criteria
Inclusion Criteria: People with pre-diabetes, or those self-identifying as at-risk for type 2 diabetes mellitus (T2DM). Risk for T2DM can be determined through indicators such as family history of T2DM, overweight or obesity, metabolic syndrome, HbA1c levels between 5.7% and 6.4%, or fasting blood glucose levels between 100 and 125 mg/dL. There is increased risk for T2DM among American Indian/Alaska Native, Black and Hispanic adults as compared with White and Asian adults; adults ages 25 and older with less than a high school education, as compared with those with higher education levels; and adults ages 25 and older with household incomes less than $25,000 as compared with those with higher income levels. Exclusion Criteria: People who have been diagnosed with T2DM or tested at an HbA1c% level that indicates T2DM. (\>6.4%) People who are non-English speaking (this is a feasibility/pilot study, if effective we will propose a fully-powered trial that we plan to translate into Spanish). The curriculum we are using has a Spanish version that we can make available if needed once a participant is enrolled. Additionally, the study coordinator is a student listed on this application who is fluent in Spanish and can help those with limited English capability to ensure participants understand the study and what is expected. People who are unable to attend in-person cooking classes at the UNLV Nutrition Center for 6 weeks using their own means of transportation. People who are unwilling to undergo multiple finger-sticks for determining HbA1c, lipids, and glucose levels. Anyone who has been diagnosed with cardiovascular or metabolic diseases, and or using medications currently to control blood glucose, including Metformin or insulin. People who have uncontrolled high blood pressure (SBP: \>=140/DBP \>=90) People who have implantable metal; (e.g., pacemaker) because body composition will be measured via bioimpedance. People who are actively trying to lose weight, or currently enrolled in a weight loss program or other dietary intervention. People who have dietary restrictions including those following a vegan diet, gluten-free diet, or with food allergies to any fruits or vegetables.
Efficacy and Safety of LID104 in the Treatment of Type II Diabetes Mellitus
NCT05886088
Not yet recruiting
Conditions Type 2 Diabetes Mellitus
Phase PHASE3
Enrollment 597
Locations 1 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-30
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study is to evaluate the efficacy and safety of LID104 in the treatment of type 2 diabetes mellitus.

Design

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

Interventions / Regimen

  • Drug: LID104 — Experimental
  • Drug: Dapagliflozin — Active comparator
  • Drug: Linagliptin — Active comparator

Primary Outcomes

  • Glycated hemoglobin (HbA1c) (120 days)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Not yet recruiting
Start Date: 2024-02
Completion: 2027-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 597 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: EMS
Contact Information
Study Contact:
Alexandra F D Alves, MSc
1938878917
pesquisa.clinica@ncfarma.com.br
Interventions
  • Drug: LID104 — Experimental
  • Drug: Dapagliflozin — Active comparator
  • Drug: Linagliptin — Active comparator
Study Locations (1 sites)
Investigational site, Hortolândia, São Paulo Brazil
Eligibility Criteria
Inclusion Criteria: * Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the consent form; * Diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goal of HbA1c with previous dietary, physical exercise and monotherapy with the maximum tolerated dose of metformin at a stable dose in the last 3 months and which, in the Investigator's discretion, may benefit from the addition of the trial drugs. * Participants with HbA1c ≥ 7.5% and ≤ 10.5% at the screening visit. * Participants with body mass index ≤ 45 kg/m2 Exclusion Criteria: * Any clinical observation or laboratory condition finding that is interpreted by the investigating physician as a risk to the participation of the research participant in the clinical trial or presence of uncontrolled chronic disease(s); * History of alcohol and/or illicit drug use disorder in the last two years; * Participants who are pregnant, nursing or planning to become pregnant, or female participants of childbearing potential who are not using reliable contraception; * Participants with known allergy or hypersensitivity to the components of the drugs used during the clinical trial; * Participants with a current medical history of cancer and/or treatment for cancer in the last five years; * Participation in a clinical trial protocols in the last 12 months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator judges that there may be a direct benefit at the same; * Type 1 Diabetes Mellitus; * Fasting glucose above 300 mg/dL; * Participants who have risk factors for severe volume depletion; * Participants on dialysis; * History of metabolic acidosis and/or using medications that may cause lactic acidosis; * Participants who have had a cardiovascular event (acute myocardial infarction, acute coronary syndrome, recent onset of stable angina, stroke, unstable congestive heart failure requiring change in treatment), who underwent a revascularization procedure or vascular surgery in the six months prior to screening; * Known heart failure, class III to IV (New York Heart Association); * Moderate or severe renal insufficiency; * Participant with altered liver function, defined by serum levels of aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase above three times the upper limit of normal or bilirubin \> 1.5 times the upper limit of normal; * Participants who underwent bariatric surgery in the last two years and/or other gastrointestinal surgeries that may cause chronic malabsorption; * Medical history of haemoglobinopathies, blood dyscrasia or any other hemolytic disorders; * Known medical history of pancreatic diseases that may suggest insulin deficiency; * Known uncontrolled hypothyroidism or hyperthyroidism or thyroid-stimulating hormone (TSH) dosage greater than 1.5 times the reference value; * Known history of sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte changes or uncontrolled seizures in the six months prior to trial screening, or any other condition that, in the judgment of the investigator, may favor clinically significant alterations in the levels of the enzyme creatine phosphokinase (CPK) or participants with CPK dosages greater than ten times the value considered for normality; * Participants who started treatment with anti-obesity drugs less than three months ago or with a dose change in the last three months; * Participants with current and prolonged treatment for more than fifteen days with systemic steroids at the time of informed consent or in the last three months prior to the screening visit; * Participants on insulin therapy or using oral antidiabetics other than metformin; * Participants using prohibited medications according to the study protocol.
A Trial on the Treatment of Bronchial Asthma With Budesonide Formoterol Combined With Immune Modulators (Staphylococcus and Neisseria Tablets)
NCT06895460
Not yet recruiting
Conditions Bronchial Asthma
Phase PHASE3
Enrollment 198
Locations 1 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-29
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial on the Treatment of Bronchial Asthma with Budesonide Formoterol Combined with Immune Modulators (Staphylococcus and Neisseria Tablets)

Design

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

Interventions / Regimen

  • Drug: Budesonide Formoterol — Investigator Selection
  • Drug: Placebo — Placebo: 0.3 mg/tablet, 4 tablets per dose, 3 times per day, for a course of 3 months
  • Drug: Immune Modulators (Staphylococcus and Neisseria Tablets) — Staphylococcus and Neisseria Tablets: 0.3 mg/tablet, 4 tablets per dose, 3 times per day, for a course of 3 months

Primary Outcomes

  • The overall asthma control rate at 12 weeks of treatment (week 12)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Not yet recruiting
Start Date: 2025-06-20
Completion: 2027-09-30
Eligibility
Age: 14 Years
Sex: ALL
Volunteers: false
Enrollment: 198 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
Contact Information
Study Contact:
Xin Yao, Chief physician
+8618651608881
xyao1998@126.com
Interventions
  • Drug: Budesonide Formoterol — Investigator Selection
  • Drug: Placebo — Placebo: 0.3 mg/tablet, 4 tablets per dose, 3 times per day, for a course of 3 months
  • Drug: Immune Modulators (Staphylococcus and Neisseria Tablets) — Staphylococcus and Neisseria Tablets: 0.3 mg/tablet, 4 tablets per dose, 3 times per day, for a course of 3 months
Study Locations (1 sites)
The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, Nanjing, Jiangsu 210000 China
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 14 years, male or female; 2. Confirmed diagnosis of asthma at least 6 months prior to screening; 3. Patients with uncontrolled asthma (according to the 2024 GINA guidelines-asthma control level classification criteria, patients with partially controlled and uncontrolled asthma); 4. Within the past 6 months, at least one of the following positive test results for lung function: * Positive bronchodilator test with an increase in FEV1 of ≥12%, and an absolute increase in FEV1 of ≥200 ml; * Positive bronchial provocation test or exercise challenge test; * Peak expiratory flow (PEF) variability over 2 weeks with a daily variation rate of ≥20% or a weekly average variation rate of ≥10%; * Significant improvement in lung function after 4 weeks of asthma treatment, with an increase in FEV1 of ≥12%, an absolute increase in FEV1 of ≥200 ml, or an improvement in PEF of ≥20%; 5. Before the first administration of the study drug, the patient has good function of major organs and no contraindications to ICS + LABA treatment; 6. The participant (or their legal representative) must sign and date the informed consent form, indicating their understanding of the study's purpose and the procedures involved, and their willingness to participate in the study. Exclusion Criteria: 1. Patients with a history of severe asthma (according to the definition in the Guidelines for the Prevention and Treatment of Bronchial Asthma (2024 Edition)); 2. Patients in the acute exacerbation phase who may require intravenous/oral corticosteroids; 3. Patients with rheumatology and immunology conditions; 4. Atypical asthma or comorbidities such as pulmonary tuberculosis, chronic obstructive pulmonary disease, bronchiectasis, pulmonary embolism, severe respiratory failure, or other respiratory system diseases; 5. Individuals with significant diseases other than bronchial asthma. Significant diseases are defined as conditions that, in the investigator's judgment, may place the participant at risk or affect the study results, such as severe cardiovascular, cerebrovascular, hepatic, renal, hematologic diseases, malignancies, psychiatric disorders, immune system diseases, or pulmonary organic functional impairments; 6. Individuals allergic to the study drug or corticosteroids; 7. Participation in another clinical trial within 30 days prior to screening or currently ongoing; 8. Use of immune modulators (including thymosin, thymopeptides, interferon, transfer factor, Bacillus Calmette-Guérin polysaccharides, any type of bacterial extracts, such as Biostim, bacterial lysate capsules) within 30 days prior to the use of the study drug or during the study period; 9. Women who are currently pregnant or breastfeeding, or women of childbearing potential who cannot use contraception during the study period; 10. The participant is deemed unsuitable for study observation by the investigator.
Registry of Asthma Characterization and Recruitment 3 (RACR3)
NCT05272241
Recruiting
Conditions Asthma
Phase Not Applicable
Enrollment 1500
Locations 7 sites
Compensation Compensation varies
Data Updated 2026-07-29
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Study Details Design, interventions, and primary outcomes

About This Study

This is a multi-center, non-interventional registry to create and maintain a database of participants to serve as a recruitment source for current and future DAIT NIAID-sponsored Childhood Asthma in Urban Settings (CAUSE) studies.

Design

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

Primary Outcomes

  • Number of participants with asthma and allergy characteristics (7 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2022-04-15
Completion: 2028-05
Eligibility
Age: No restriction
Sex: ALL
Volunteers: true
Enrollment: 1500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigators:
  • Christine A. Sorkness, RPh, PharmD (STUDY_CHAIR) - University of Wisconsin School of Medicine and Public Health; Division of Allergy & Immunology
  • Daniel J. Jackson, MD (STUDY_CHAIR) - University of Wisconsin School of Medicine and Public Health; Division of Allergy & Immunology
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (7 sites)
Children's Hospital Colorado: Allergy Program, Aurora, Colorado 80045 United States
Children's National Medical Center: Inner City Asthma Consortium (ICAC) Clinical Research Site, Washington D.C., District of Columbia 20010 United States
Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology, Chicago, Illinois 60611 United States
Boston Children's Hospital: Department of Immunology, Boston, Massachusetts 02215 United States
Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute, New York, New York 10029 United States
Columbia University Medical Center: Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine, New York, New York 10032 United States
Cincinnati Children's Hospital Medical Center: Asthma Center, Cincinnati, Ohio 45229 United States
Eligibility Criteria
Inclusion Criteria: 1. Participant is either: 1. At least 18 years old, willing and able to provide informed consent at the time of enrollment 2. Under the age of 18, accompanied by a legal guardian who is willing and able to provide informed consent at the time of enrollment 2. Participant has a primary place of residence within the Office of Management and Budget (OMB)-defined Metropolitan Statistical Area (MSA) Exclusion Criteria: 1. Participant does not speak English or Spanish and/or guardian does not speak English or Spanish 2. Participant does not have access to a phone, either personal or public, with regularity that could be used for scheduling and safety follow-up 3. Past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may affect the quality or interpretation of the data obtained from the study Participants who are pregnant or lactating will not be excluded or discontinued from the study, but will not undergo any procedures that are prohibited during pregnancy per the Childhood Asthma in Urban Settings 02 (CAUSE-02) Registry for Asthma Characterization and Recruitment 3 (RACR3) Manual of Procedures (MOP)(e.g., allergen skin testing, spirometry) during the pregnancy. Potential participants may be reassessed as outlined in the Protocol CAUSE-02 MOP.
Somatic Health Screening for Adults in Outpatient Psychiatric Care in Denmark (SomaScreen)
NCT07518446
Recruiting
Conditions Atrial Fibrillation (AF), Heart Failure,...
Phase NA
Enrollment 2800
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-29
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

People with severe mental illness have a substantially increased risk of undiagnosed and insufficiently treated somatic disease. Somatic Screening in the Capital Region Mental Health Service in Denmark (SomaScreen) is a service-level intervention implemented in psychiatric outpatient clinics in the Capital Region of Denmark to improve the detection and follow-up of somatic disease among patients with psychotic and affective disorders. This study evaluates whether integrating structured somatic screening into mental health services leads to improved identification and management of somatic disease compared with care as usual. Using a quasi-experimental controlled design with a matched cohort, outcomes among patients exposed to the SomaScreen intervention are compared with those of patients receiving usual care in comparable psychiatric outpatient clinics outside the Capital Region.

Design

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

Interventions / Regimen

  • Diagnostic Test: Somatic Health Screening for Adults in Outpatient Psychiatric Care in Denmark (SomaScreen) — SomaScreen is a structured somatic health screening program for adults in psychiatric outpatient care (F-ACT and OPUS clinics). Trained somatic nurses and general practitioner consultants systematically assess patients for cardiovascular disease, asthma, chronic obstructive pulmonary disease (COPD), diabetes, and cancer, and may detect other somatic conditions. Patients with identified conditions are referred to their own general practitioner for follow-up and management. The intervention is distinguished from usual care by its systematic, multi-condition screening and structured referral process.

Primary Outcomes

  • Previously Undiagnosed Somatic Illness (2 years from start of intervention)
  • Management of Somatic Conditions (2 years from start of intervention)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-09-01
Completion: 2028-10-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 2800 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Amager Hospital
Principal Investigators:
  • Lene F Eplov, MD, PhD, Associate Professor (PRINCIPAL_INVESTIGATOR) - Amager Hospital
Contact Information
Study Contact:
Lene F Eplov, MD, PhD, Associate Professor
+4520184687
Lene.Falgaard.Eplov@regionh.dk
Ziggi I Santini, PhD
+4524257369
ziggi.santini@regionh.dk
Interventions
  • Diagnostic Test: Somatic Health Screening for Adults in Outpatient Psychiatric Care in Denmark (SomaScreen) — SomaScreen is a structured somatic health screening program for adults in psychiatric outpatient care (F-ACT and OPUS clinics). Trained somatic nurses and general practitioner consultants systematically assess patients for cardiovascular disease, asthma, chronic obstructive pulmonary disease (COPD), diabetes, and cancer, and may detect other somatic conditions. Patients with identified conditions are referred to their own general practitioner for follow-up and management. The intervention is distinguished from usual care by its systematic, multi-condition screening and structured referral process.
Study Locations (1 sites)
Amager Hospital, Copenhagen, 2300 Denmark
Eligibility Criteria
Inclusion Criteria: * Patients aged 18 years or older. * Referred to FACT or OPUS psychiatric outpatient clinics in the Capital Region of Denmark. * Starting a new outpatient treatment episode in FACT or OPUS. * Diagnosed with psychotic or affective disorders (ICD-10 F20-F39), including those with comorbid substance use disorders (F10-F19). Exclusion Criteria: * Individuals younger than 18 years. * Patients in geriatric outpatient clinics. * Individuals not in the target diagnosis group (i.e., without psychotic or affective disorders, F20-F39). * Individuals who do not meet the inclusion criteria above.
Development of the Drug and Alcohol Respiratory Health Test
NCT06921278
Not yet recruiting
Conditions Respiratory Disease, Substance-Related D...
Phase Not Applicable
Enrollment 260
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-29
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this study is to develop a brief Drug and Alcohol Respiratory Health Test (DARHT) and offer it for routine use in clinical assessment and medical reviews

Design

Study type: Observational Observational model: Other Time perspective: Other

Primary Outcomes

  • A brief respiratory health screening questionnaire (Day 1 and Day 3-7)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2025-04-15
Completion: 2025-11-11
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 260 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: King's College London
Collaborators: South London and Maudsley NHS Foundation Trust
Contact Information
Study Contact:
John Marsden, B.Sc., M.Sc., PhD, PgDiP CBT
+44 02078365454
john.marsden@kcl.ac.uk
Francesca Small, Msc
+ 44 020 3228 1500
francesca.a.small@kcl.ac.uk
Interventions
N/A
Study Locations (1 sites)
South London & Maudsley NHS Trust, London, BR3 3BX United Kingdom
Eligibility Criteria
Inclusion Criteria: 1. \>18 (no upper age limit) 2. Inhalation (smoking) of tobacco, or cannabis, or cocaine, or opioids, or use of alcohol in the past 28 days 3. Possession of a personal mobile phone to arrange follow-up appointments Exclusion Criteria: 1. Reported physical health condition that would mean spirometry contra-indicated - including heart attack, unstable angina, pulmonary embolism, 2. Reported surgery in the past 3 months for an eye, chest, or abdominal condition that would mean spirometry contra-indicated 3. Likely inability to complete study due to criminal justice involvement with legal proceedings risking incarceration
Wessex Asthma Cohort of Difficult Asthma
NCT03996590
Active, positions filled
Conditions Asthma
Phase Not Applicable
Enrollment 566
Locations 3 sites
Compensation Compensation varies
Data Updated 2026-07-29
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Asthma is now widely recognised to be a heterogeneous disease. The last two decades have seen the identification of a number of biological targets and development of various novel therapies. Despite this, asthma still represents a significant health and economic burden worldwide. Why some individuals should continue to suffer remains unclear. The Wessex Asthma Cohort of Difficult Asthma (WATCH) is an ongoing 'real-life', prospective study of patients in the University Hospital Southampton Foundation Trust (UHSFT) Difficult Asthma service. Research data capture is aligned with the extensive clinical characterisation required of a commissioned National Health Service (NHS) Specialist Centre for Severe Asthma. Data acquisition includes detailed clinical, health and disease-related questionnaires, anthropometry, allergy and lung function testing, radiological imaging (in a small subset) and collection of biological samples (blood, urine and sputum). Prospective data are captured in parallel to clinical follow up appointments, with data entered into a bespoke database. The pragmatic ongoing nature of the WATCH study allows comprehensive assessment of the real world clinical spectrum seen in a Specialist Asthma Centre and allows a longitudinal perspective of deeply phenotyped patients. It is anticipated that the WATCH cohort would act as a vehicle for potential collaborative asthma studies and will build upon our understanding of mechanisms underlying difficult asthma.

Design

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

Primary Outcomes

  • Cohort Characterisation (35 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2015-04-22
Completion: 2050-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 566 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: University Hospital Southampton NHS Foundation Trust
Collaborators: Novartis, Boehringer Ingelheim, National Institutes of Health (NIH), Owlstone Ltd, National Institute for Health Research, United Kingdom
Principal Investigators:
  • Ramesh J Kurukulaaratchy, DM FRCP (PRINCIPAL_INVESTIGATOR) - University Hospital Southampton NHS Foundation Trust
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (3 sites)
Portsmouth Hospitals NHS Trust, Portsmouth, Hamsphire PO6 3LY United Kingdom
University Hospital Southampton NHS Foundation Trust, Southampton, Hamsphire SO16 6YD United Kingdom
Isle of Wight NHS Trust, Newport, Isle Of Wight PO30 5TG United Kingdom
Eligibility Criteria
Inclusion Criteria: * All patients referred to the Adult or Transitional Regional Asthma Clinics at participating hospitals. * On high-dose therapies, with or without the addition of continuous or frequent use of oral steroids (or steroid sparing therapies), as defined by the BTS (British Thoracic Society) Adult Asthma Management Guidelines (2016). Exclusion Criteria: * Asthma patients who are not referred to the Adult or Transitional Regional Asthma Clinics at participating hospitals. * Any patients who are not on high-dose therapies, with or without the addition of continuous or frequent use of oral steroids (or steroid sparing therapies), as per the BTS (British Thoracic Society) Adult Asthma Management Guidelines (2016).
Impact of Sarcopenia on Dyspnea in Patients With Asthma
NCT06870890
Not yet recruiting
Conditions Sarcopenia, Asthma, Dyspnea, Dyspnea; As...
Phase NA
Enrollment 100
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-29
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Dyspnea in asthma, is mainly due to airway obstruction but can be caused by several alternative diagnoses. The impact of sarcopenia on dyspnea in patients with asthma is unknown. Sarcopenic asthma had a reduced physical activity and is associated with airway obstruction compared to non-sarcopenic asthma. In patients with obstructive pulmonary disease, sarcopenia is associated with shallow breathing and diverse sensory and affective components of exertional dyspnea . The morbidity of sarcopenia is also increased by systemic inflammation and the production of inflammatory cytokines as found in inflammatory airway obstruction. The investigators will investigate the prevalence and impact of sarcopenia in asthmatics patients. This will enable to better manage sarcopenia in asthmatic patients, understand its origins and personalize treatment.

Design

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

Interventions / Regimen

  • Diagnostic Test: muscle evaluation — The investigators will evaluate the muscle mass and muscle strenght for all patients included
  • Biological: Dosage — Evaluation of the cinetic of biomarkers during exercise
  • Diagnostic Test: Cardiopulmonary exercise test — CPET
  • Combination Product: Questionnaire and Physical Exam — Evaluating dyspnea, anxiety, sleep, physical activity, quality of life

Primary Outcomes

  • Variation in the intensity of dyspnea during exercise mesured with Borg scale (0-10) according to the presence of sarcopenia (From baseline (at rest) to the end of the exercise)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2025-03-25
Completion: 2026-10
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Hospital, Clermont-Ferrand
Principal Investigators:
  • Camille ROLLAND-DEBORD (PRINCIPAL_INVESTIGATOR) - University Hospital, Clermont-Ferrand
Contact Information
Study Contact:
Lise Laclautre
334.73.754.963
promo_interne_drci@chu-clermontferrand.fr
Interventions
  • Diagnostic Test: muscle evaluation — The investigators will evaluate the muscle mass and muscle strenght for all patients included
  • Biological: Dosage — Evaluation of the cinetic of biomarkers during exercise
  • Diagnostic Test: Cardiopulmonary exercise test — CPET
  • Combination Product: Questionnaire and Physical Exam — Evaluating dyspnea, anxiety, sleep, physical activity, quality of life
Study Locations (1 sites)
CHU Clermont-Ferrand, Clermont-Ferrand, France
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Patient affiliated to a social security scheme. * Patient capable of giving free, informed, written and signed consent. * Asthmatic patients with a diagnosis made by a pulmonologist on GINA level 4 or 5 treatment * ACT asthma control score \< 20 * Patient judged by the investigator to be able to to perform a maximal exercise test. Exclusion Criteria: * Patient under guardianship/trusteeship/supervision of justice * Pregnant or breast-feeding women * Unstable heart disease * Patients who have been smoking or have stopped smoking for less than 5 years,