Status:
RECRUITING
Extracellular Vesicles, Insulin Action, and Exercise
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Virginia
Conditions:
Type 2 Diabetes
Obesity
Eligibility:
All Genders
30-80 years
Phase:
NA
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 ...
Detailed Description
Insulin resistance is a key underlying factor promoting hyperglycemia and hypertension in people with type 2 diabetes (T2D), who have a 3-fold greater cardiovascular disease (CVD) risk when compared w...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Participants with morbid obesity (BMI \>45 kg/m2) and under-/overweight patients (BMI: ≤18 or 25-27.99 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 ≥8.0%
- Participants who are smokers or who have quit smoking ≤5 years ago
- Participants prescribed metformin, GLP-1 agonists (oral/injectable), TZDs, DPP-IV inhibitors, Acarbose, SGLT-2 inhibitors within 1 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).
Key Trial Info
Start Date :
February 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06546085
Start Date
February 10 2025
End Date
April 1 2029
Last Update
July 3 2025
Active Locations (3)
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1
Institute for Food, Nutrition, and Health
New Brunswick, New Jersey, United States, 08901
2
Robert Wood Johnson University Hospital Clinical Research Center
New Brunswick, New Jersey, United States, 08901
3
Rutgers University Loree Gymnasium
New Brunswick, New Jersey, United States, 08901