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NCT Number: NCT07699367

Metformin and ACLR Muscle Recovery

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.

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Key information

Conditions

Atrophy Inflammation Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Weakness, Muscle

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

metformin

Drug

Individuals randomized to the metformin group will take metformin daily (up to 2grams/day) for 4 months following ACLR surgery.

Placebo

Other

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.

Primary outcomes

  1. Thigh Muscle Fibrosis

    Time frame: Measured at 4 months after ACLR surgery

    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.

  2. Thigh Muscle Cellular Senescence

    Time frame: Measured at 4 months following ACLR surgery.

    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

  3. Knee extensor muscle strength

    Time frame: Measured at 4 months following ACLR surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Micah Drummond

CONTACT

[email protected]

801-213-2737

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Metformin and Muscle Recovery Following ACL Surgery

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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