Metformin and ACLR Muscle Recovery
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Utah
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 40y and older
BMI: <30 kg/m2
Full thickness ACL tear
Less than 6 months between ACL injury and scheduled ACLR
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Metformin
DrugIndividuals randomized to the metformin group will take metformin daily (up to 2grams/day) for 4 months following ACLR surgery.
Placebo
Other interventionIndividuals randomized to the placebo will take the same number of pills as the metformin group daily over a 4 month period following ACLR surgery.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: MetforminExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Measured at 4 months after ACLR surgery2
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
Time frame
Measured at 4 months following ACLR surgery.3
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.
Time frame
Measured at 4 months following ACLR surgerySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: