Metformin and ACLR Muscle Recovery

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT07699367
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Atrophy
  • Inflammation
  • Weakness, Muscle

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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 Dates

First listed
Jul 13, 2026
Start date
Nov 1, 2026
Status verified
Jul 2026
Primary completion
Oct 1, 2031
Completion
Oct 1, 2032

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Metformin
    Individuals randomized to metformin group will take the intervention daily for 4 months after ACLR surgery
  • Placebo Comparator: Placebo
    Individuals randomized to placebo group will take the treatment daily for 4 months after ACLR surgery

Primary Outcome Measure

Thigh Muscle Fibrosis [ Time Frame: Measured at 4 months after ACLR surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of UtahSalt Lake CityUtah84112-

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By research site
University of Utah· Salt Lake City, UT

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