Recruiting

Extracellular Vesicles

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT06546085

Conditions

Type 2 Diabetes

Obesity

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Accepted

Interventions

Exercise

Study Details

Brief summary:

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.

Conditions

Type 2 Diabetes

Obesity

Study ID

NCT06546085

Start date

Feb 10, 2025

Status verified date

Jan, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

no intervention: Lean with Normal Glucose Tolerance

Participants will not receive the study intervention and will be healthy controls.

experimental: Obesity with Normal Glucose Tolerance

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.

experimental: Obesity with Type 2 Diabetes

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.

Interventions

Exercise

Supervised treadmill exercise at 85% VO2max, 3x/wk for 16 weeks. Exercise duration will be adjusted based on individual VO2-heart rate (HR) relationship so that \~400 kcals will be expended during each training session.

Primary outcome measure

  • Change in Extracellular Vesicles during insulin infusion [ Time Frame: From enrollment to the end of treatment at 16 weeks. ]

Central Contacts and Locations

Central contacts

Steven K Malin, PhD

848-932-7540steven.malin@rutgers.edu

Emily M Heiston, PhD

848-932-7540emily.heiston@rutgers.edu

Locations

Institute for Food, Nutrition, and Health

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Sue Shapses, PhD

848-932-9403shapses@rutgers.edu

Robert Wood Johnson University Hospital Clinical Research Center

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Fei Chen

732-235-5966chenf2@rwjms.rutgers.edu

Rutgers University Loree Gymnasium

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Steven K Malin, PhD

848-932-7540steven.malin@rutgers.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-01-23.