Status:
COMPLETED
Exercise Dose and Metformin for Vascular Health in Metabolic Syndrome
Lead Sponsor:
Rutgers University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
PHASE3
Brief Summary
Health organizations recommend exercise in an intensity based manner to promote cardiovascular adaptation and prevent disease. Metformin is a common anti-diabetes medication that reduces future type 2...
Eligibility Criteria
Inclusion
- Male or female ≥40 and ≤80 years old.
- Has a body mass index ≥25 and ≤47 kg/m2.
- Not diagnosed with Type 2 or Type 1 diabetes
- Not currently engaged in \> 150 min/wk of exercise
- Weight stable (\<2kg weight change in past 3 months)
- Non-smoking \>5 years
- At minimum, subject will have abdominal obesity (increased waist circumference as defined below) and may have any additional National Cholesterol Education Adult Treatment Panel III Metabolic Syndrome criteria:
- Increased waist circumference (≥102 cm in men; ≥88 cm in women)
- Elevated triglycerides (≥150 mg/dl), or on medication for treating the condition
- Reduced HDL-cholesterol (\<40mg/dl in men, \<50 mg/dl in women), or on medication for treating the condition
- High blood pressure (≥130 mmHg systolic or ≥85mmHg diastolic), or on medication for treating the condition
- Elevated fasting glucose (≥100 mg/dl), or on medication for treating the condition
- Other major risk factors to be noted based on the Framingham Risk Score
- HbA1c 5.7-6.4%
- LDL \> 130 mg/dL
- Family history of type 2 diabetes (immediate family, i.e. parent/sibling)
- History of gestational diabetes
- History of Polycystic Ovarian Syndrome
- Family history of pre-mature cardiovascular disease (immediate family i.e. parent/sibling) before 55 for males or 65 for females that can include heart attack, peripheral arterial disease, abdominal aortic aneurysm, symptomatic carotid artery disease or clinical coronary heart disease)
- Age ( \> 45 years old for men; \> 55 years old for women)
- Black/African American, Mexican, Asian, and/or Hispanic
- Subjects currently taking medications that affect heart rate and rhythm (i.e. Ca++ channel blockers, nitrates, alpha- or beta-blockers)
Exclusion
- Subjects prescribed metformin or have taken metformin within 1 year.
- Subjects with abnormal estimated glomerular filtration rate (eGFR).
- Hypertriglyceridemic (\>400 mg/dl) and hypercholesterolemic (\>260 mg/dl) subjects
- Hypertensive (\>160/100 mmHg)
- Subjects with a history of significant metabolic, cardiac, congestive heart failure, 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
- Subjects with contraindications to participation in an exercise training program
- Currently taking active weight suppression medication (e.g. phentermine,orlistat, lorcaserin, naltrexone-bupropion in combination, liraglutide, benzphetamine, diethylpropion, phendimetrazine)
- Known hypersensitivity to perflutren (contained in Definity)
- Subjects who are considered non-English speaking individuals
Key Trial Info
Start Date :
August 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2024
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT03355469
Start Date
August 7 2017
End Date
May 23 2024
Last Update
September 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rutgers University Loree Gymnasium
New Brunswick, New Jersey, United States, 08901