NCT06546085Recruiting
Extracellular Vesicles, Insulin Action, and Exercise
Extracellular Vesicles, Insulin Action, and Exercise on Vascular Function in Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
Extracellular vesicles (EVs) play a role in obesity-induced insulin resistance and likely impact the development of cardiovascular disease. However, little is known on how EVs affect vascular insulin action in people. The purpose of this study is to understand how EVs play a role in type 2 diabetes related cardiovascular disease. This research will also study if exercise can change how EVs impact blood flow and metabolic health. This study will contribute to designing precision medicine to treat/prevent cardiovascular disease in type 2 diabetes.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 6 Aug 2024
- Start date
- 10 Feb 2025
- Primary completion date
- Jan 2029
- Lead sponsor
- Rutgers, The State University of New Jersey
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06546085
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 10 Feb 2025 to the primary completion date, Jan 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants prescribed metformin, GLP-1 agonists (oral/injectable), TZDs, DPP-IV inhibitors, Acarbose, SGLT-2 inhibitors within 6 year.
Other illness
- Evidence of type 1 diabetes and diabetics requiring insulin therapy.
- 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.
- Known hypersensitivity to perflutren (contained in Definity).
Lab values
- T2D with HbA1c ≥10.0%
- 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).
- Abnormal liver function (reflective from comprehensive panel liver enzymes Alk (≥121 IU/L), AST (≥40 IU/L) and ALT (≥32 IU/L) via LabCorp).
- Suggested infections at time of screening as confirmed by WBC (≥10.8 x10E3/uL) and/or platelets (≥450 x10E3/uL).
Age
- Participants who are smokers or who have quit smoking ≤2 years ago
Other
- Participants with morbid obesity (BMI \>45 kg/m2) and underweight patients (BMI: ≤18 kg/m2).
- Intolerance to insulin
- 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)
- Hypertensive (≥160/100 mmHg) at time of screening.
- Pregnant (as evidenced by positive pregnancy test) or nursing women
- Participants with contraindications to participation in an exercise training program
- Anemic as confirmed by hematocrit (HCT) (women ≤36%, Men ≤38%) at time of screening.
Who the study is looking for
- 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.
Age in the registry: 30 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rutgers University Loree Gymnasium Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
| Institute for Food, Nutrition, and Health Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
| Robert Wood Johnson University Hospital Clinical Research Center Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.