Metformin for Muscle Health in Older Adults

Overseen By Brenda Northrup

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Utah

Must not be taking: Anticoagulants, Corticosteroids, Estrogen

Disqualifiers: Cardiovascular disease, Diabetes, Cancer, others

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how metformin, a common diabetes medication, might help older adults maintain muscle and metabolic health during bed rest. Researchers aim to determine if metformin can prevent muscle loss and improve insulin sensitivity in healthy older adults confined to bed. Participants will receive either metformin or a placebo (a non-active pill) for a short period. Suitable candidates are those aged 60 and older who are generally healthy and live independently. As an Early Phase 1 trial, this research focuses on understanding metformin's effects in people, offering participants a chance to contribute to groundbreaking insights.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop all current medications, but you cannot participate if you are using anticoagulant therapy or chronic systemic corticosteroids. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that metformin is generally well-tolerated by many people. It is commonly used to manage blood sugar levels in type 2 diabetes. Some individuals have reported side effects such as stomach pain, muscle pain, and fatigue. There is also a rare risk of lactic acidosis, a serious buildup of acid in the blood, but this is uncommon. Most people taking metformin do not experience severe side effects. Since this trial is in the early phase, it primarily focuses on understanding the treatment's safety. While metformin is widely used, the trial will closely monitor its effects on participants, especially as it is being tested for a new use in improving muscle health in older adults after bed rest. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using metformin for muscle health in older adults because it offers a potentially novel approach to maintaining muscle mass. Unlike traditional treatments that might focus on exercise or dietary supplements, metformin is a medication commonly used for diabetes that may also improve muscle function by enhancing insulin sensitivity and reducing inflammation. This dual action could help preserve muscle health during periods of inactivity, like bed rest, which is especially beneficial for older individuals who are more susceptible to muscle loss. Additionally, metformin's established safety profile makes it a promising candidate for repurposing to support muscle health.

What evidence suggests that metformin might be an effective treatment for muscle health in older adults?

Research shows that metformin, which participants in this trial may receive, might help maintain healthier muscles in older adults. Studies have found that metformin can enhance muscle function and reduce frailty, particularly in older adults with high blood pressure. One study found that metformin aids special cells crucial for muscle repair. However, not all studies agree; some found that metformin didn't improve physical performance in older adults with muscle loss. Overall, the evidence suggests possible benefits, but results can vary. ^{6 7 8 9 10}

Who Is on the Research Team?

Micah Drummond

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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.

You are unable to stop smoking for the entire study.

Subjects excluded due to positive screening results, including HIV, hepatitis B or hepatitis C, will be immediately scheduled for counseling and follow-up testing as needed, and will be advised to consult their primary physician

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Metformin Run-in

Participants receive metformin incrementally to reach a clinical dose of 2 grams per day over a 2-week period

2 weeks

Daily visits (in-person or virtual)

Bed Rest

Participants undergo 5 days of bed rest while receiving metformin or placebo to assess changes in insulin sensitivity and muscle size

5 days

Continuous monitoring during bed rest

Recovery

Participants are monitored for recovery of muscle size, strength, and insulin sensitivity after bed rest

7 days

Regular assessments (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Metformin
• Placebo

Trial Overview The 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.

How Is the Trial Designed?

Group I: Metformin (Bed Rest) Experimental Treatment 1 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 Treatment 1 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 Group 1 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 Group 1 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 European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Glucophage for:

• Type 2 diabetes

Approved in United States as Glucophage for:

• Type 2 diabetes

Approved in Canada as Glucophage for:

• Type 2 diabetes

Approved in Japan as Glucophage for:

• Type 2 diabetes

Approved in China as Glucophage for:

• Type 2 diabetes

Approved in Switzerland as Glucophage for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

Insulin therapy does not effectively prevent muscle atrophy in older diabetic patients, highlighting a need for alternative treatments.

While some anti-diabetic drugs like glitazones and AMPK agonists show promise, they may also have unfavorable effects, such as inducing muscle atrophy, particularly in older individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the antidiabetic drugs on the age-related atrophy and sarcopenia associated with diabetes type II. Cetrone, M., Mele, A., Tricarico, D.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8982084/

The Function of Metformin in Aging-Related Musculoskeletal ... In a study of non-prediabetic pre-frail elderly patients, it was found that gait speed was significantly higher in older adults taking metformin ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666756825000145

Metformin and physical performance in older people with ... We found that metformin did not improve measures of physical performance, activities of daily living or quality of life in older people with sarcopenia and ...

3. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-025-06357-x

Exploring the protective effect of metformin against sarcopenia Studies also indicate that metformin could reduce frailty and improve muscle function in older adults, particularly those with hypertension and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8965502/

Metformin in aging and aging-related diseases: clinical ... Metformin, the most widely used antidiabetic drug, has been reported to delay aging and display protective effect on attenuating progression of various aging- ...

5. withpower.com withpower.com/trial/early-phase-1-insulin-resistance-7-2019-194d1

Metformin for Muscle Health in Older Adults Research suggests that short-term metformin use in older adults can improve the function of muscle progenitor cells, which are important for muscle repair and ...

6. webmd.com webmd.com/drugs/2/drug-11285-7061/metformin-oral/metformin-oral/details

Metformin (Glucophage, Glumetza, and others): Uses, Side ... What are the serious side effects of metformin? · General ill feeling · Muscle pain · Difficulty breathing · Drowsiness · Stomach pain.

7. mayoclinic.org mayoclinic.org/drugs-supplements/metformin-oral-route/description/drg-20067074

Metformin (oral route) - Side effects & dosage Metformin is used to treat high blood sugar levels that are caused by a type of diabetes mellitus or sugar diabetes called type 2 diabetes.

8. drugs.com drugs.com/metformin.html

Metformin: Uses, Dosage, Side Effects, Warnings Metformin side effects · unusual muscle pain; · feeling cold; · trouble breathing; · feeling dizzy, light-headed, tired, or very weak; · stomach pain ...

9. medsafe.govt.nz medsafe.govt.nz/profs/datasheet/m/metformintab.pdf

metformin Diagnosis. The risk of lactic acidosis must be considered in the event of non-specific signs such as malaise, myalgia, muscle cramps, respiratory distress, ...

10. rxlist.com rxlist.com/metformin/generic-drug.htm

Metformin: Side Effects, Uses, Dosage, Interactions ... Serious side effects of Metformin include: hives,; difficulty breathing,; swelling in your face, lips, tongue, or throat,; unusual muscle pain,; feeling cold, ...