[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07699367":3,"trial-entities:NCT07699367":83,"trial-summary:NCT07699367":87},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":40,"secondary_outcomes":53,"sex":54,"minimum_age":55,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":56,"std_ages":60,"locations":63,"central_contacts":72,"overall_officials":78,"references":81,"see_also_links":82},"NCT07699367","204197","Metformin and ACLR Muscle Recovery","Metformin and Muscle Recovery Following ACL Surgery","NOT_YET_RECRUITING","2032-10-01","2026-07","2026-07-13","2026-11-01","University of Utah","OTHER",false,"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.",null,[19,20,21],"Atrophy","Inflammation","Weakness, Muscle",[],"INTERVENTIONAL","BASIC_SCIENCE",[26],"EARLY_PHASE1",{"count":28,"type":29},40,"ESTIMATED",[31,36],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Metformin","Individuals randomized to the metformin group will take metformin daily (up to 2grams\u002Fday) for 4 months following ACLR surgery.",[33],{"type":14,"name":37,"description":38,"armGroupLabels":39},"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.",[37],[41,45,49],{"measure":42,"description":43,"timeFrame":44},"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",{"measure":46,"description":47,"timeFrame":48},"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.",{"measure":50,"description":51,"timeFrame":52},"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",[],"ALL","40 Years",{"inclusion":57,"exclusion":58,"raw_text":59},[],[],"Inclusion Criteria:\n\n1. Age between 40y and older\n2. BMI: \\\u003C30 kg\u002Fm2\n3. Full thickness ACL tear\n4. Less than 6 months between ACL injury and scheduled ACLR\n\nExclusion Criteria:\n\n1. Prior ACL tear in limb scheduled for reconstruction or current bilateral ACL tear\n2. Total knee dislocation\n3. Anticipated quadriceps ACLR grafts\n4. Current infection near the lower limb\n5. Inability to attend physical therapy sessions\n6. Post-operative loading restrictions\n7. History of cardiovascular disease (e.g., CHF, CAD, MI, CVA)\n8. History of endocrine or metabolic disease such as hypo\u002Fhyperthyroidism and diabetes (Treated hypo\u002Fhyperthyroid for at least 6 months will be permitted)\n9. History of stroke with motor disability\n10. History of respiratory disease (acute upper respiratory infection, history of chronic lung disease)\n11. Self-reported pregnancy\n12. Bleeding disorder\n13. Implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)\n14. Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma\n15. Chronic systemic corticosteroid use (≥ 2 weeks) within 4 weeks of enrollment and for study duration (intra-articular\u002Ftopical\u002Finhaled therapeutic or physiologic doses of corticosteroids will be permitted)\n16. Androgens or growth hormone within 6 months of enrollment and for study duration (topical physiologic androgen replacement will be permitted)\n17. Currently taking estrogen products (topical estrogen products will be permitted)\n18. Taking anticoagulant medication (warfarin\u002FCoumadin, heparin) that may complicate the muscle biopsy\n19. Any staff members who report directly to the principal investigators",[61,62],"ADULT","OLDER_ADULT",[64],{"facility":13,"city":65,"state":66,"zip":67,"country":68,"geoPoint":69},"Salt Lake City","Utah","84112","United States",{"lat":70,"lon":71},40.76078,-111.89105,[73],{"name":74,"role":75,"phone":76,"email":77},"Micah Drummond","CONTACT","801-213-2737","micah.drummond@hsc.utah.edu",[79],{"name":74,"affiliation":13,"role":80},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":84,"biomarkers":86},[85],"Injury of anterior cruciate ligament",[],{"nct_id":4,"found":88,"summary":89,"prompt_version":98},true,{"design":90,"status":91,"heading":6,"summary":92,"follow_up":93,"word_count":94,"commitments":95,"compensation":96,"drugs_mentioned":97},"This is an interventional study with 40 planned participants. Individuals will be randomly assigned to receive either metformin or a placebo.","completed","This study is investigating whether metformin, a medication, can help improve muscle recovery after anterior cruciate ligament reconstruction (ACLR) surgery. After ACLR, some people experience increased muscle collagen (fibrosis) and inflammation, which can slow down recovery and impact leg strength. Researchers want to see if taking metformin daily for 4 months after surgery can reduce muscle fibrosis, cellular senescence (aging of cells), and improve leg strength. You might be able to join if you are 40 years or older, have a BMI under 30, a full ACL tear, and your surgery is scheduled within 6 months of your injury. Participants will be randomly assigned to receive either metformin or a placebo (an inactive pill). The study aims to see if metformin helps improve muscle strength and reduce inflammation. The current status of this study is unclear.","Participants will be followed up 8 months after the intervention period to assess lasting effects.",136,"Participants will take metformin or a placebo daily for 4 months after ACLR surgery. Muscle strength and inflammatory markers will be measured after this period.","Not stated in the trial record.",[33,37],"v2"]