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Biguanide

Metformin for Muscle Health in Older Adults

Phase < 1

Waitlist Available

Led By Micah Drummond

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 60y and older

Be older than 18 years old

Must not have

Personal history of cardiovascular disease

Vascular disease or risk factors of peripheral atherosclerosis (e.g., uncontrolled hypertension, obesity, diabetes)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in muscle size from baseline to 5-days of bed rest will be compared between groups after 5 days of bed rest

Summary

This trial investigates whether metformin can help prevent muscle loss and insulin resistance in healthy older adults who are bedridden.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Metformin may cause side effects such as digestive upset (nausea, diarrhea), low blood sugar levels especially when combined with other diabetes medication, vitamin B12 deficiency over long-term use which could lead to anemia or neuropathy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of heart disease.

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

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My thyroid and blood sugar levels are under control.

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My kidney function is impaired (creatinine > 1.5mg/dL).

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I am currently on blood thinners like Coumadin or heparin.

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I do not have HIV or hepatitis B or C.

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I am currently on a diet to lose weight or my BMI is over 30.

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I have liver or respiratory issues.

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I have had a gastrointestinal bleed in the last year.

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I have cancer or was treated for cancer, other than skin cancer, less than a year ago.

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I have had a stroke that affected my ability to move.

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My blood pressure is not higher than 160/100.

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I have been diagnosed with depression based on the GDS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in insulin sensitivity from baseline to 5-days of bed rest will be compared between groups after 5 days of bed rest

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in insulin sensitivity from baseline to 5-days of bed rest will be compared between groups after 5 days of bed rest

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in insulin sensitivity from baseline to 5-days of bed rest will be compared between groups after 5 days of bed rest for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insulin sensitivity

Muscle size

Trial Design

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.

0 / 14Eligibility criteria met