Exercise Dose and Metformin for Vascular Health in Metabolic Syndrome

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Metabolic Syndrome

In brief

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 diabetes and cardiovascular disease (CVD) risk. However, the optimal dose of exercise to be combined with metformin for vascular health remains unknown. The purpose of this study is to evaluate whether combining high or low intensity exercise with metformin has the potential to outperform either exercise intensity alone on blood flow across the arterial tree as well as impact insulin action in individuals with metabolic syndrome. Identification of such outcomes will indicate 1) whether and how metformin should be combined with physical activity for CVD prevention, 2) provide the first indication of whether exercise intensity reduces CVD risk via multi-level vasculature function vs. metabolic insulin action, and 3) provide a rational early treatment for people with metabolic syndrome to prevent/treat type 2 diabetes and CVD.

Key facts

Study ID: NCT03355469
Run by: Rutgers University
People needed: 91
Starts: 2017-08-07
Expected to finish: 2024-05-23
Last updated by the study team: 2025-09-22

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

Rutgers University Loree Gymnasium — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.