Understanding how exercise and extracellular vesicles affect insulin action in diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the role of extracellular vesicles (EVs) in insulin resistance related to type 2 diabetes and their impact on cardiovascular health. It aims to determine how exercise influences EV behavior and its subsequent effects on blood flow and metabolic health. Participants will be grouped based on their obesity and diabetes status, and various measurements will be taken to assess insulin signaling and vascular function. The findings could lead to more personalized treatment strategies for cardiovascular disease in individuals with type 2 diabetes.

Why it matters

Who can join: the full rules

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).

Where it's running

• Institute for Food, Nutrition, and Health
  New Brunswick, New Jersey, United States Recruiting
• Robert Wood Johnson University Hospital Clinical Research Center
  New Brunswick, New Jersey, United States Recruiting
• Rutgers University Loree Gymnasium
  New Brunswick, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Steven K Malin, PhD — Rutgers University - New Brunswick
• Study coordinator: Steven K Malin, PhD
• Email: steven.malin@rutgers.edu
• Phone: 848-932-7540

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.