CompletedPhase 3

Antecedent Metabolic Health and Metformin Aging Study

United States101 participantsStarted 2020-07-29

Plain-language summary

Aging is the number one risk factor for the majority of chronic diseases. There are no pharmaceutical treatments to slow aging and prolong healthspan. The anti-diabetic drug metformin is considered a likely pharmaceutical candidate to slow aging. In this study, the investigators hypothesize that metformin treatment in subjects free of type 2 diabetes will improve insulin sensitivity and glucoregulation in insulin resistant individuals, but will decrease insulin sensitivity and glucoregulation in insulin sensitive subjects. Further, the investigators hypothesize that long-term metformin treatment will remodel mitochondria in a way that decreases mitochondrial function in subjects that are insulin sensitive, but improves mitochondrial function in subjects that are insulin resistant. The investigators will use a dual-site, 12- week drug intervention trial performed in a double-blind, placebo-controlled manner on 148 subjects recruited from two separate sites (Oklahoma Medical Research Foundation (OMRF) and University of Wisconsin-Madison (UWM)). After consent and initial subject screening for chronic disease, subjects will be stratified to insulin sensitive (IS) or insulin resistant (IR) groups. Over a 12- week intervention, half of each group will take metformin and half will take a placebo. Pre- and post--intervention, subjects will complete a series of procedures to assess insulin sensitivity, glucose regulation, and biomarkers of aging. The same subjects will provide a skeletal muscle biopsy pre-- and post-intervention to assess the change in mitochondrial function and mitochondrial remodeling with and without metformin treatment. By completion of this project, the investigators expect to provide evidence that helps further delineate who may benefit from metformin treatment to slow aging.

Who can participate

Age range

40 Years – 75 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: * 40-75 years of age (inclusive) * Free of chronic disease * Comprehension of the protocol as indicated by an ability to respond to questions about the study after reading the consent form. * Able to use and be contacted by telephone. * Able to speak, read, and understand English, and complete a questionnaire in English * Independently mobile Exclusion Criteria: * Pregnancy * Heart disease (history, abnormal ECG, abnormal stress ECG) * Cerebrovascular disease (history) * Cancer (history) * Chronic respiratory disease (history, forced expiratory volume at one second/forced vital capacity \[FEV1/FVC\] \< 70, FEV1 \< 80% predicted) * Chronic liver disease (history, alanine transaminase \[ALT\] \> 52 IU/L) * Diabetes (history, HbA1C ≥ 6.5, fasting blood glucose≥126 mg/dl, oral glucose tolerance test \[OGTT\] ≥ 200 mg/dl at 2 hrs) * Impaired kidney function (eGFR ,45 mL/min) * B12 lab values outside of normal range (\<193 or \>982 pg/mL) * Alzheimer's (history) * Chronic kidney disease (history, abnormal blood kidney panel including serum creatinine \> 1.4) * Problems with bleeding, on medication that prolongs bleeding time (if subject cannot safely stop prior to biopsy) * Those on glucose lowering drugs * Those planning to have imaging that requires intravenous contrast dye (within 6 weeks) or are on any of the following medications since they are contraindicated with the use of metformin: Dofetilide, Lamotrigine, Pegvisomant, Somatropin, Trimethoprim, Tros…

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

Mean change in insulin sensitivity measure

Timeframe: Change from baseline to 12 weeks

Mean change in mitochondrial function of the electron transport system measured by complex I activity

Timeframe: Change from baseline to 12 weeks

Trial details

NCT IDNCT04264897

SponsorOklahoma Medical Research Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-12

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