Genomic Outcomes of Metformin

• Status: Completed
• Trial end date: 2018-11-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborator: National Institute on Aging (NIA)
• Treatments: Metformin

Criteria

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 be ineligible for)

• Thyroid problems the PI deems them to be ineligible for

• Gout

• Involved in another interventional study

• Hemoglobin <8 or diagnosed with anemia

• Recent unintentional weight change (+/- 10 lbs. in the last 12 months)

• BMI <18.5

• Likely to not follow the protocol

• PI deems unfit to participate

• Already taking Metformin or any other drug intended to treat diabetes