An Early Phase 1 interventional study of Metformin and Placebo in Atrophy, Inflammation and Weakness, Muscle, sponsored by University of Utah. Not yet recruiting at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by University of Utah · Early Phase 1, Interventional, and Basic science
The purpose of this research study is to determine if Metformin taken after anterior cruciate ligament reconstruction (ACLR) surgery can decrease muscle fibrosis, cellular senescence and improve leg strength. ACL injury and surgery increase muscle collagen content and inflammation which slows the recovery of muscle and function and ultimately impacts the quality of life. Individuals enrolled in the study will be randomized to receive metformin (or placebo) for 4 months after surgery. The investigators will measure muscle strength and inflammatory markers in muscle biopsy samples after the intervention period. Investigators will also follow up with participants 8 months later to determine the lasting effects of the intervention.
Exclusion Criteria:
Individuals randomized to metformin group will take the intervention daily for 4 months after ACLR surgery
Drug: Metformin
Individuals randomized to placebo group will take the treatment daily for 4 months after ACLR surgery
Other: Placebo
Individuals randomized to the metformin group will take metformin daily (up to 2grams/day) for 4 months following ACLR surgery.
Individuals randomized to the placebo will take the same number of pills as the metformin group daily over a 4 month period following ACLR surgery.
Thigh Muscle Fibrosis
Muscle collagen content (% Sirius Red Stain) will be measured in muscle biopsy samples from the involved thigh after 4 months of treatment and compared between the metformin and placebo groups.
Time frame: Measured at 4 months after ACLR surgery
Thigh Muscle Cellular Senescence
Muscle cellular senescence (% SA Beta galactosidase) will be measured in muscle biopsy samples from the involved thigh after 4 months treatment and will be compared between the metformin and placebo groups
Time frame: Measured at 4 months following ACLR surgery.
Knee extensor muscle strength
Knee extensor muscle strength from the involved leg (maximal voluntary isometric contraction; force) will be measured using an isokinetic dynamometer after 4 months of treatment and compared between the metformin and placebo groups.
Time frame: Measured at 4 months following ACLR surgery
Plan to share: No — IPD can be requested by the PI, Dr. Micah Drummond.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University of Utah