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Not yet recruiting NCT07699367

Metformin and ACLR Muscle Recovery

Early Phase I Interventional Atrophy Inflammation Weakness, Muscle

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metformin, Placebo.
Who it may be relevant to
Registry conditions: Atrophy, Inflammation, Weakness, Muscle. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Metformin and Muscle Recovery Following ACL Surgery

Overview

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.

Interventions

  • Drug Metformin
    Individuals randomized to the metformin group will take metformin daily (up to 2grams/day) for 4 months following ACLR surgery.
  • Other Placebo
    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 outcome measures

  • Thigh Muscle Fibrosis [Time frame: Measured at 4 months after ACLR surgery]
  • Thigh Muscle Cellular Senescence [Time frame: Measured at 4 months following ACLR surgery.]
  • Knee extensor muscle strength [Time frame: Measured at 4 months following ACLR surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Utah — Salt Lake City

Identifiers

NCT: NCT07699367 · 204197

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗