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Extracellular Vesicles, Insulin Action, and Exercise
Extracellular Vesicles, Insulin Action, and Exercise on Vascular Function in Type 2 Diabetes
Who can join
Ages 30 to 80 · All sexes · Healthy volunteers welcome
Full eligibility criteria
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).
About the study
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.
What is being tested
- Exercise (behavioral)
Sponsor: Rutgers, The State University of New Jersey · Participants: 60 · Started: Feb 10, 2025
Contact the study team
- Steven K Malin, PhD · Phone: 848-932-7540
- Emily M Heiston, PhD · Phone: 848-932-7540
Official record on ClinicalTrials.gov — NCT06546085
Locations in the U.S.
| New Jersey | Institute for Food, Nutrition, and Health, New Brunswick Robert Wood Johnson University Hospital Clinical Research Center, New Brunswick Rutgers University Loree Gymnasium, New Brunswick |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.