Extracellular Vesicles, Insulin Action, and Exercise

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT06546085
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Exercise — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Feb 10, 2025
Status verified
Jan 2026
Primary completion
Jan 31, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Institute for Food, Nutrition, and HealthNew BrunswickNew Jersey08901
Sue Shapses, PhD
[email protected]
848-932-9403
Robert Wood Johnson University Hospital Clinical Research CenterNew BrunswickNew Jersey08901
Fei Chen
[email protected]
732-235-5966
Rutgers University Loree GymnasiumNew BrunswickNew Jersey08901
Steven K Malin, PhD
[email protected]
848-932-7540

Find similar trials in New Brunswick, NJ

By condition
Obesity / overweightType 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Institute for Food, Nutrition, and Health· New Brunswick, NJRobert Wood Johnson University Hospital Clinical Research Center· New Brunswick, NJRutgers University Loree Gymnasium· New Brunswick, NJ

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