Metformin for Muscle Health in Older Adults

Recruiting in Palo Alto (17 mi)

Overseen byMicah Drummond

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of Utah

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

Muscle atrophy and insulin resistance are common after bed rest in healthy older adults. Metformin treatment has been shown to improve insulin sensitivity and attenuate muscle loss in insulin resistance adults though the mechanisms are not fully known. Metformin used as a preventive strategy to maintain muscle and metabolic health in bed ridden older adults has not been investigated.

Research Team

Micah Drummond

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for healthy older adults aged 60 and above who can consent to participate. They must not have serious health issues like uncontrolled diseases, recent cancer (except basal cell carcinoma), kidney or liver disease, respiratory problems, cardiovascular conditions, or be on certain medications like anticoagulants.

Inclusion Criteria

You are living independently before being admitted.

Ability to sign informed consent

I am 60 years old or older.

Exclusion Criteria

I have a history of heart disease.

I have vascular disease or risk factors like high blood pressure, obesity, or diabetes.

You are unable to stop smoking for the entire study.

See 19 more

Treatment Details

Interventions

Metformin (Biguanide)
Placebo (Drug)

Trial OverviewThe study tests if Metformin helps maintain muscle and metabolic health in bedridden older adults. Participants will either receive Metformin or a placebo while undergoing bed rest. Some participants will only take the assigned treatment during a two-week run-in period before bed rest.

Participant Groups

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Metformin (Bed Rest)Experimental Treatment1 Intervention

Metformin will be given to participants incrementally during a 2 week run in period such that they will receive the clinical dose (2 grams per day). During bed rest, participants will be given 1 gram of metformin two times a day (morning and evening). This dosage and frequency will occur during four consecutive days of bed rest.

Group II: Metformin (2 week run-in only)Experimental Treatment1 Intervention

Metformin will be given to participants incrementally during a 2 week run in period such that they will receive the clinical dose (2 grams per day). These participants will not participate in the bed rest portion of the protocol.

Group III: Placebo (2 week run-in only)Placebo Group1 Intervention

Placebo will be given to participants incrementally during a 2 week run in period such that they will receive the same amount of pills as the experimental group. These participants will not participate in the bed rest portion of the protocol.

Group IV: Placebo (Bed Rest)Placebo Group1 Intervention

Placebo will be given to participants incrementally during a 2 week run in period such that they will receive the same amount of pills as the experimental group. During bed rest, participants will be given the same amount of pills and given at the same time of day (morning and evening) as the experimental group. This strategy will occur during four consecutive days of bed rest.

Metformin is already approved in Canada, Japan, China, Switzerland for the following indications: