CompletedPhase 4

Genomic Outcomes of Metformin

United States30 participantsStarted 2016-08-03

Plain-language summary

Medical scientists have found that people with diabetes who take the drug Metformin have less age-related disease than those taking other treatments and researchers believe it may prevent numerous diseases and conditions that effect older people. In addition, metformin extends lifespan in some animal models of human disease. The purpose of this study is to see if taking Metformin causes changes in blood cells consistent with improved health and longevity in people who do not have diabetes. In this study Metformin will be compared to placebo. A placebo is a substance, like a sugar pill, that is not thought to have any effect on a participants disease or condition. In this study participants will either receive the active study medication, Metformin or placebo which is not active. Placebos are used in research studies to see if the drug being studied really does have an effect.

Who can participate

Age range

65 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 65 - 79 Must meet criteria from one or more of the following groups: Group 1 (Can have 1 or 2 of these, but not all 3) * History of coronary artery disease (MI/heart attack, stroke, heart failure, or peripheral artery disease) * Cancer, with no active treatment in the last year * MCI (MoCA \>18\<26 -inclusive of 1 point if \<12 years of education Group 2 * Decline physical function (walking speed \< 1 m/s) Group 3 (Either or both) * Abdominal obesity (\>88cm women, \>102cm men) AND hypertension (treated or resting blood pressure \>140/90 * Abdominal obesity (\>88cm women, \>102cm men) AND hyperlipidemia (treated or fasting total cholesterol \>240 English literacy Willing to provide informed consent Exclusion Criteria: * eGFR \<45 * Type 2 diabetes (HbA1c\>6.5) or type 1 diabetes * Any tobacco or nicotine product use in the past year * Low vitamin B12 Levels (\< 300 pg/mL) * Self-reported severe difficulty or inability to walk 400m or climb 10 steps (from Q 2 and 19 on PAT-D) * Self-reported difficulty or inability to perform basic ADL functions (from Q 10, 13, 14, 16 on PAT-D) * Excessive alcohol use (\>14 drinks/week) * Cancer requiring treatment in past year (except skin) * Dementia - diagnosed and/or MoCA score \<18 * Parkinson's or other neurological disease * Chronic liver disease or cirrhosis * End stage renal disease or on dialysis * Rheumatic conditions (Rheumatoid arthritis, lupus, and any other autoimmune disease the -PI deems them to…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Eigengene Scores

Timeframe: baseline through 12 weeks

Change in Eigengene Scores

Timeframe: baseline through 24 weeks

Trial details

NCT IDNCT02986659

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-11-15

Results submitted2022-04-29

View on ClinicalTrials.gov More Coronary Artery Disease trials