Combination therapy shows promise in reversing frailty in older veterans

NCT ID NCT04221750

Completed Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed phase 3 trial tested whether a lifestyle program (diet and exercise) plus the drug metformin could reverse frailty and sarcopenic obesity in 114 older veterans aged 65-85. Participants followed a weight-loss diet and exercised three times a week, while taking metformin daily. The main goal was to see if their physical performance improved, measured by tasks like walking and climbing stairs.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Metformin hydrochloride
What this could lead to: If successful, this combination of diet, exercise, and metformin could offer a practical way to reduce frailty and improve physical function in older adults with obesity.
What could go wrong: This is a completed phase 3 trial with 114 participants, so results are limited in size. The intervention requires significant lifestyle changes, which may not be sustainable for everyone. Metformin can cause gastrointestinal side effects.

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Conditions

The condition(s) this trial relates to.

Frailty obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AGING FRAILTY SARCOPENIC OBESITY

Contacts and locations

Locations

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

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