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Exercise and Extracellular Vesicles in Type 2 Diabetes and Obesity

This study is looking at how exercise affects tiny particles called extracellular vesicles (EVs) in people with type 2 diabetes and obesity. EVs are thought to play a role in how the body uses insulin and in heart disease. Researchers want to understand if regular exercise can change how these EVs impact blood flow and overall metabolic health. You might be able to join if you are 30-80 years old, have type 2 diabetes or normal blood sugar, and meet certain BMI requirements. You also need to be taking specific medications for diabetes like metformin or GLP-1 agonists. The main goal is to see how EVs change during insulin infusion after 16 weeks of exercise. The study's current status is unclear.

Study design
This interventional study plans to enroll 60 participants. It will investigate the effects of exercise on extracellular vesicles.
What's involved
You would participate in supervised treadmill exercise three times a week for 16 weeks. The exercise duration will be adjusted to burn about 400 calories per session.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, change in Extracellular Vesicles, is measured from enrollment to the end of treatment at 16 weeks.

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NCT06546085

Extracellular Vesicles, Insulin Action, and Exercise

Recruiting
NAAges 30–80InterventionalBasic science
Rutgers, The State University of New Jersey
~60 participants
Updated 2026-01-23 on ClinicalTrials.gov
What's tested:Exercise

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Extracellular Vesicles during insulin infusion
Measured over From enrollment to the end of treatment at 16 weeks.

Conditions

Type 2 Diabetes
Obesity

Explore related trials

ObesityType 2 Diabetes Mellitus

Where it's being run

3 sites across 1 states
New Jersey3

Study leadership

  • Steven K Malin, PhD · PRINCIPAL_INVESTIGATOR · Rutgers University - New Brunswick

Who to contact

Steven K Malin, PhD
[email protected]
848-932-7540
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Change in Extracellular Vesicles during insulin infusionFrom enrollment to the end of treatment at 16 weeks.

    Extracellular vesicles (CD41 -CD31+, CD45, Tx, CD31, CD105) will be isolated from plasma before and during insulin stimulation.