RecruitingPrediabetic StateAtherosclerosisMetformin

Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes

Eligible age

18+ yrs

Accepts

All genders

Locations

28 states

Healthy volunteers

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About this study

This research will help us to learn if the medicine called metformin reduces the risk of death, heart attacks, and/or strokes in Veterans who have pre-diabetes and heart or blood vessel problems.

Sponsor: VA Office of Research and Development

You may qualify if…

✓ 1. Pre-diabetes: This condition is fulfilled by HbA1c of at least 5.7%, but less than 6.5%; or two measurements of fasting plasma glucose (on separate days) of 100-125 mg/dL; or a 2-hour plasma glucose level of 140-199 mg/dL following a 75 g glucose load oral glucose tolerance test.
✓ 2. Established atherosclerotic cardiovascular disease: Qualifying participants must have evidence of atherosclerotic disease in at least one of the following vascular beds: coronary, cerebrovascular, or peripheral arterial circulation.
✓ Coronary artery disease is fulfilled by at least one of (1), (2), or (3):
✓ 1. History of myocardial infarction at least one month prior to randomization.
✓ 2. History of percutaneous coronary intervention or coronary artery bypass surgery at least one month prior to randomization.
✓ 3. Angiographic evidence of coronary stenosis of at least 50% in at least two major epicardial coronary arteries.
✓ Cerebrovascular disease is fulfilled by at least one of criteria (1) through (4):
✓ 1. Documented prior ischemic stroke (at least one month prior to randomization),

You may not qualify if…

✕ 1. Treatment with metformin or other anti-diabetic medication within 12 months of randomization. Note: In the absence of a diagnosis of diabetes, inpatient treatment with insulin or treatment with an SGLT2 inhibitor (e.g., for heart failure) or a GLP-1 receptor agonist (e.g., for obesity) is not exclusionary.
✕ 2. Treatment with systemic glucocorticoids within 3 months of randomization
✕ 3. Fasting plasma glucose greater than 130 mg/dL measured between screening and randomization visits, or any plasma glucose 180 mg/dL or HbA1c 7.0% measured within 12 months of randomization.
✕ 4. Total CO2 below the local laboratory lower limit of normal on most recent blood chemistry panel
✕ 5. Current treatment with cimetidine, vandetanib, or a systemic treatment with a carbonic anhydrase inhibitor.
✕ 6. Cirrhosis, active hepatitis, or jaundice at time of randomization, or total bilirubin \> 2 times upper limit of normal
✕ 7. Binge or heavy alcohol consumption within 6 months of randomization
✕ 8. Severe anemia (hemoglobin \< 10 g/dL)