Extracellular Vesicles, Insulin Action, and Exercise on Vascular Function in Type 2 Diabetes

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: t
View:

• 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 ≥1 year.

• Has a body mass index of 20-25 or 28-45 kg/m2.

• Not diagnosed with Type 1 diabetes.

• Not currently engaged in \>150 min/wk of exercise.

Locations
United States
New Jersey
Institute for Food, Nutrition, and Health
RECRUITING
New Brunswick
Robert Wood Johnson University Hospital Clinical Research Center
RECRUITING
New Brunswick
Rutgers University Loree Gymnasium
RECRUITING
New Brunswick
Contact Information
Primary
Steven K Malin, PhD
steven.malin@rutgers.edu
848-932-7540
Backup
Emily M Heiston, PhD
emily.heiston@rutgers.edu
848-932-7540
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2029-04
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Virginia
Leads: Rutgers, The State University of New Jersey

This content was sourced from clinicaltrials.gov