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Extracellular Vesicles, Insulin Action, and Exercise

Rutgers, The State University of New Jersey · with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Virginia · NCT06546085

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 30–80 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
60
US sites recruiting
3
Study start
February 10, 2025
Record last updated
January 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Exercise

Conditions: Type 2 Diabetes; Obesity

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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).

Recruiting US locations

  • Institute for Food, Nutrition, and Health

    New Brunswick, NJ 08901

    Site contact: Sue Shapses, PhD · 848-932-9403 · shapses@rutgers.edu

  • Robert Wood Johnson University Hospital Clinical Research Center

    New Brunswick, NJ 08901

    Site contact: Fei Chen · 732-235-5966 · chenf2@rwjms.rutgers.edu

  • Rutgers University Loree Gymnasium

    New Brunswick, NJ 08901

    Site contact: Steven K Malin, PhD · 848-932-7540 · steven.malin@rutgers.edu

Study contacts (from the official record)

  • Steven K Malin, PhD · 848-932-7540 · steven.malin@rutgers.edu
  • Emily M Heiston, PhD · 848-932-7540 · emily.heiston@rutgers.edu
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