Taking people in United StatesNo phase

Studies how exercise affects blood vessels in type 2 diabetes

Tests whether exercise changes vesicle effects on blood flow in adults with type 2 diabetes.

Key facts

Who runs it: Rutgers, The State University of New Jersey
Where: New Brunswick, United StatesSee the 3 sites
Trial code: NCT06546085
Registry title: Extracellular Vesicles, Insulin Action, and Exercise
Status: Recruiting
People taking part: 60 people, planned
Started: 10 Feb 2025
Expected to end: Apr 2029
Type of study: Interventional, 3 groupsOne group gets no study treatment, for comparison.
Treatments tested: Exercise
Record updated: 23 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 30 to 80, with or without type 2 diabetes, who are not very active, to study how extracellular vesicles and exercise affect blood vessels.

Age: 30 to 80 years
Sex: Men and women
Disease stage: Either normal blood sugar (HbA1c under 5.7% (39 mmol/mol) and fasting glucose under 100 mg/dl (5.6 mmol/L)) or type 2 diabetes (HbA1c 6.5% (48 mmol/mol) or higher and fasting glucose 126 mg/dl (7 mmol/L) or higher). Body mass index 20 to 45 kg/m2.
Earlier treatment: People with type 2 diabetes must have been prescribed diabetes medicine such as metformin, GLP-1 agonists, TZDs, DPP-IV inhibitors, Acarbose or SGLT-2 inhibitors for 6 years or more. People must not exercise more than 150 minutes a week.

Main reasons for not taking part

Type 1 diabetes or needing insulin therapy
HbA1c of 10.0% (86 mmol/mol) or higher
Smokers, or quit smoking 2 years ago or less
Pregnant or nursing women
Kidney, liver, heart or other significant disease, or high blood pressure (160/100 mmHg or higher)

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

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

Who cannot take part

Participants prescribed metformin, GLP-1 agonists (oral/injectable), TZDs, DPP-IV inhibitors, Acarbose, SGLT-2 inhibitors within 6 year
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)
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)
Participants who are smokers or who have quit smoking ≤2 years ago
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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 30 and 80 years old?

Where in United States

Institute for Food, Nutrition, and HealthNew Brunswick, United StatesContact: Sue Shapses, PhDTaking people
Robert Wood Johnson University Hospital Clinical Research CenterNew Brunswick, United StatesContact: Fei ChenTaking people
Rutgers University Loree GymnasiumNew Brunswick, United StatesContact: Steven K Malin, PhDTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

Lean with Normal Glucose ToleranceNo study treatment, for comparison
Participants will not receive the study intervention and will be healthy controls.
Obesity with Normal Glucose ToleranceTreatment being tested
Participants with obesity and normal glucose tolerance will participate in 3 supervised exercise training sessions at 85% VO2max that expends \~400 kcal for 16 weeks.
Treatment: Exercise
Obesity with Type 2 DiabetesTreatment being tested
Participants with obesity and type 2 diabetes will participate in 3 supervised exercise training sessions at 85% VO2max that expends \~400 kcal for 16 weeks.
Treatment: Exercise