Phase 4 N=30 Randomized Quadruple-blind Health Services Research

Genomic Outcomes of Metformin

Coronary Artery Disease · Mild Cognitive Impairment · Obesity, Abdominal · Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT02986659 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2023

Primary outcome: Primary: Change in Eigengene Scores — .035; -0.032 Eigen Score

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Metformin (Drug); Placebo (Drug)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Nov 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Eigengene Scores	.011; -0.018	—
PRIMARY Change in Eigengene Scores	.011; -0.018	—
SECONDARY Functional Measures--macroautophagy	—	—
SECONDARY Functional Measures--microautophagy	—	—
SECONDARY Functional Measures--chaperone-mediated Autophagy	—	—
SECONDARY Mitochondria Function: Respiratory Control Ratio (RCR)	—	—
SECONDARY Mitochondria Function: State 3 (Maximal Oxygen Consumption Rate)	—	—
SECONDARY Mitochondria Function: State 4 (Oxygen Consumption Upon Inhibition of ATP Synthase)	—	—

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.

Eligibility 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 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 6.5) or type 1 diabetes
Any tobacco or nicotine product use in the past year
Low vitamin B12 Levels ( 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02986659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.