Understanding how exercise and extracellular vesicles affect insulin action in diabetes
Extracellular Vesicles, Insulin Action, and Exercise on Vascular Function in Type 2 Diabetes
NA · Rutgers, The State University of New Jersey · NCT06546085
This study is testing how exercise affects tiny particles in the body that may influence insulin action and heart health in people with type 2 diabetes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey (other) |
| Locations | 3 sites (New Brunswick, New Jersey and 2 other locations) |
| Trial ID | NCT06546085 on ClinicalTrials.gov |
What this trial studies
This study investigates the role of extracellular vesicles (EVs) in insulin resistance related to type 2 diabetes and their impact on cardiovascular health. It aims to determine how exercise influences EV behavior and its subsequent effects on blood flow and metabolic health. Participants will be grouped based on their obesity and diabetes status, and various measurements will be taken to assess insulin signaling and vascular function. The findings could lead to more personalized treatment strategies for cardiovascular disease in individuals with type 2 diabetes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40-70 with type 2 diabetes or normal glucose tolerance who are not currently engaged in regular exercise.
Not a fit: Patients with morbid obesity, type 1 diabetes, or those requiring insulin therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved strategies for preventing cardiovascular disease in patients with type 2 diabetes.
How similar studies have performed: While the role of EVs in insulin resistance is being explored, this specific approach combining exercise and EVs in humans is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female 30 - 80 years old. * HbA1c \<5.7% and fasting glucose \<100mg/dl to be considered NGT * T2D diagnosis or confirmation HbA1c ≥6.5% and fasting glucose ≥126 mg/dl * Prescribed metformin, GLP-1 agonists (oral/injectable), TZDs, DPP-IV inhibitors, Acarbose, SGLT-2 inhibitors ≥6 year. * Has a body mass index of 20-24.99 or 25.0-45 kg/m2. * Not diagnosed with Type 1 diabetes. * Not currently engaged in \>150 min/wk of exercise. Exclusion Criteria: * Participants with morbid obesity (BMI \>45 kg/m2) and underweight patients (BMI: ≤18 kg/m2). * Intolerance to insulin * Evidence of type 1 diabetes and diabetics requiring insulin therapy. * Participants who have not been weight stable (≥2 kg weight change in past 6 months) * Participants who have been recently active in past 6 months via health screening questions (≥150 min of moderate/high intensity exercise) * T2D with HbA1c ≥10.0% * Participants who are smokers or who have quit smoking ≤2 years ago * Participants prescribed metformin, GLP-1 agonists (oral/injectable), TZDs, DPP-IV inhibitors, Acarbose, SGLT-2 inhibitors within 6 year. * Hypertriglyceridemic (≥400 mg/dl) and hypercholesterolemic (≥260 mg/dl) participants as determined from LabCorp samples. * Kidney dysfunction as determined from LabCorp biochemical outcomes (e.g. creatinine (≥1.0 mg/dl), eGFR (≤59 ml/min/1.73), BUN (≥24 mg/dl) as derived from comprehensive metabolic panels). * Hypertensive (≥160/100 mmHg) at time of screening. * Abnormal liver function (reflective from comprehensive panel liver enzymes Alk (≥121 IU/L), AST (≥40 IU/L) and ALT (≥32 IU/L) via LabCorp). * History of significant metabolic, cardiac, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or cancer that in the investigator's opinion would interfere with or alter the outcome measures, or impact subject safety. * Pregnant (as evidenced by positive pregnancy test) or nursing women * Participants with contraindications to participation in an exercise training program * Known hypersensitivity to perflutren (contained in Definity). * Anemic as confirmed by hematocrit (HCT) (women ≤36%, Men ≤38%) at time of screening. * Suggested infections at time of screening as confirmed by WBC (≥10.8 x10E3/uL) and/or platelets (≥450 x10E3/uL).
Where this trial is running
New Brunswick, New Jersey and 2 other locations
- Institute for Food, Nutrition, and Health — New Brunswick, New Jersey, United States (RECRUITING)
- Robert Wood Johnson University Hospital Clinical Research Center — New Brunswick, New Jersey, United States (RECRUITING)
- Rutgers University Loree Gymnasium — New Brunswick, New Jersey, United States (RECRUITING)
Study contacts
- Principal investigator: Steven K Malin, PhD — Rutgers University - New Brunswick
- Study coordinator: Steven K Malin, PhD
- Email: steven.malin@rutgers.edu
- Phone: 848-932-7540
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes, Obesity