NCT06546085 Extracellular Vesicles, Insulin Action, and Exercise
| NCT ID | NCT06546085 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-02-10 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Steven K Malin, PhD
PRINCIPAL INVESTIGATOR
Rutgers University - New Brunswick
Frequently Asked Questions
Who can join the NCT06546085 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 80 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06546085 currently recruiting?
Yes, NCT06546085 is actively recruiting participants. Contact the research team at steven.malin@rutgers.edu for enrollment information.
Where is the NCT06546085 trial being conducted?
This trial is being conducted at New Brunswick, United States, New Brunswick, United States, New Brunswick, United States.
Who is sponsoring the NCT06546085 clinical trial?
NCT06546085 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Steven K Malin, PhD at Rutgers University - New Brunswick. The trial plans to enroll 60 participants.
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