Actively Recruiting

Phase Not Applicable
Age: 30Years - 80Years
All Genders
Healthy Volunteers
NCT06546085

Extracellular Vesicles, Insulin Action, and Exercise

Led by Rutgers, The State University of New Jersey · Updated on 2026-01-23

60

Participants Needed

3

Research Sites

215 weeks

Total Duration

On this page

Sponsors

R

Rutgers, The State University of New Jersey

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Extracellular Vesicles, Insulin Action, and Exercise

Who Can Participate

Age: 30Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 30 to 80 years
  • HbA1c less than 5.7% and fasting glucose under 100 mg/dl to be considered normal glucose tolerance
  • Diagnosis of type 2 diabetes or confirmed HbA1c of 6.5% or higher and fasting glucose of 126 mg/dl or higher
  • Prescribed metformin, GLP-1 agonists, TZDs, DPP-IV inhibitors, Acarbose, or SGLT-2 inhibitors for at least 6 years
  • Body mass index between 20 and 24.99 or between 25.0 and 45 kg/m2
  • Not diagnosed with type 1 diabetes
  • Not currently doing more than 150 minutes of exercise per week
Not Eligible

You will not qualify if you...

  • Morbid obesity with BMI over 45 kg/m2 or underweight with BMI less than 18 kg/m2
  • Intolerance to insulin
  • Diagnosis of type 1 diabetes or requiring insulin therapy
  • Weight change of 2 kg or more in past 6 months
  • Recent activity of 150 minutes or more of moderate/high intensity exercise in past 6 months
  • Type 2 diabetes with HbA1c of 10.0% or higher
  • Current smokers or quit smoking within past 2 years
  • Prescribed metformin, GLP-1 agonists, TZDs, DPP-IV inhibitors, Acarbose, or SGLT-2 inhibitors within past 6 years
  • High triglycerides (400 mg/dl or more) or high cholesterol (260 mg/dl or more)
  • Kidney dysfunction based on specific lab values
  • High blood pressure (160/100 mmHg or higher) at screening
  • Abnormal liver function tests
  • History of serious metabolic, cardiac, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, endocrine diseases or cancer affecting safety or study outcomes
  • Pregnant or nursing women
  • Contraindications to exercise training
  • Known allergy to perflutren
  • Anemia confirmed by hematocrit levels
  • Possible infections at screening confirmed by blood counts

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Institute for Food, Nutrition, and Health

New Brunswick, New Jersey, United States, 08901

Actively Recruiting

2

Robert Wood Johnson University Hospital Clinical Research Center

New Brunswick, New Jersey, United States, 08901

Actively Recruiting

3

Rutgers University Loree Gymnasium

New Brunswick, New Jersey, United States, 08901

Actively Recruiting

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Research Team

S

Steven K Malin, PhD

CONTACT

E

Emily M Heiston, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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