Metformin and ACLR Muscle Recovery

NCT07699367 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 204197
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrophy; Inflammation; Weakness, Muscle

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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.

  Measured at 4 months following ACLR surgery

Study Arms (2)

Metformin

EXPERIMENTAL

Individuals randomized to metformin group will take the intervention daily for 4 months after ACLR surgery

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Individuals randomized to placebo group will take the treatment daily for 4 months after ACLR surgery

Other: Placebo

Interventions

Metformin DRUG

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

Metformin

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.

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Atrophy; Inflammation; Muscle Weakness

Interventions

Metformin

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Micah Drummond

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Micah Drummond

CONTACT

801-213-2737; micah.drummond@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): October 1, 2032
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)