Metformin and ACLR Muscle Recovery

Starting soon · Early Phase 1 · Has a placebo group

Conditions studied: Atrophy, Inflammation, Weakness, Muscle

In brief

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.

Key facts

Study ID

NCT07699367

Run by

University of Utah

People needed

40

Starts

2026-11-01

Expected to finish

2032-10-01

Last updated by the study team

2026-07-13

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 40y and older
• BMI: <30 kg/m2
• Full thickness ACL tear
• Less than 6 months between ACL injury and scheduled ACLR

You may not qualify if…

• Prior ACL tear in limb scheduled for reconstruction or current bilateral ACL tear
• Total knee dislocation
• Anticipated quadriceps ACLR grafts
• Current infection near the lower limb
• Inability to attend physical therapy sessions
• Post-operative loading restrictions
• History of cardiovascular disease (e.g., CHF, CAD, MI, CVA)
• History of endocrine or metabolic disease such as hypo/hyperthyroidism and diabetes (Treated hypo/hyperthyroid for at least 6 months will be permitted)
• History of stroke with motor disability
• History of respiratory disease (acute upper respiratory infection, history of chronic lung disease)
• Self-reported pregnancy
• Bleeding disorder
• Implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)
• Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma
• Chronic systemic corticosteroid use (≥ 2 weeks) within 4 weeks of enrollment and for study duration (intra-articular/topical/inhaled therapeutic or physiologic doses of corticosteroids will be permitted)
• Androgens or growth hormone within 6 months of enrollment and for study duration (topical physiologic androgen replacement will be permitted)
• Currently taking estrogen products (topical estrogen products will be permitted)
• Taking anticoagulant medication (warfarin/Coumadin, heparin) that may complicate the muscle biopsy
• Any staff members who report directly to the principal investigators

Where it is running

• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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