[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530315":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":47,"responsibleParty":68,"collaborators":33,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":33,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":33,"enrollmentInfo":80,"targetDuration":33,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":33,"overallStatus":49,"whyStopped":33,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of Utah","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin","EXPERIMENTAL","Metformin pills will be given orally and daily during the 2-week recovery period following single leg immobilization Metformin will be titrated up to a dose 2g\u002Fday. 1g dose (two 500 mg pills) will be taken in the morning and a 1g dose will be taken in the evening. This will take place over each day for 14 days during the recovery period.",[13],"Drug: Metformin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo pills will be given orally and daily during the 2-week recovery period following single leg immobilization. Two pills will be taken in the morning and two pills will be taken in the evening. This will take place over each day for 14 days during the recovery period.",[19],"Other: Placebo",[21,30],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Metformin will be distributed in 500mg pills.",[9],[26,27,28,29],"Glucophage","Fortamet","Glumetza","Riomet",{"type":6,"name":15,"description":31,"armGroupLabels":32,"otherNames":33},"Placebo will be distributed in pill form",[15],null,[35],{"name":36,"affiliation":5,"role":37},"Micah Drummond","PRINCIPAL_INVESTIGATOR",[39,43],{"name":36,"role":40,"phone":41,"phoneExt":33,"email":42},"CONTACT","801-213-2737","micah.drummond@hsc.utah.edu",{"name":44,"role":40,"phone":45,"phoneExt":33,"email":46},"Rebekah Drummond","801-839-4534","u6044729@umail.utah.edu",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Salt Lake City","Utah","84112","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-111.89105,40.76078,{"lat":59,"lon":58},[62,65],{"name":63,"role":40,"phone":64,"phoneExt":33,"email":42},"Micah Drummond, PhD","8012132737",{"name":44,"role":40,"phone":66,"phoneExt":33,"email":67},"8018394524","rebekah.drummond@hsc.utah.edu",{"type":37,"investigatorFullName":36,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Professor, Physical Therapy and Athletic Training","100530315","early-phase-1-metformin-and-muscle-recovery-100530315",false,"NCT06185179","Metformin and Muscle Recovery","Use of Metformin to Improve Muscle Regrowth in Older Adults","Inclusion Criteria:\n\n1. Age between 60y and older\n2. BMI: \\\u003C30 kg\u002Fm2\n3. Good general medical health, ambulatory and in independent living setting\n4. Adequate upper body strength to use assistive walking device (crutches, walker, etc) as assessed by PI\u002Fstaff during screening\n5. Clinical Frailty Scale score \\\u003C 3\n6. Mini-Cog score \\> 3\n\nExclusion Criteria:\n\n1. History of cardiovascular disease (e.g., CHF, CAD, MI, CVA)\n2. History of endocrine or metabolic disease such as hypo\u002Fhyperthyroidism and diabetes (Treated hypo\u002Fhyperthyroid for at least 6 months will be permitted)\n3. History of kidney disease or failure (CKD \\> stage 4; serum creatinine \\>1.5mg\u002FdL)\n4. History of vascular disease\n5. Risk of DVT including family history of thrombophilia, DVT, pulmonary emboli, myeloproliferative diseases including polycythemia (Hb\\>18 g\u002FdL) or thrombocytosis (platelets\\>400x103\u002FmL), and connective tissue diseases (positive lupus anticoagulant), hyperhomocystinemia, deficiencies of factor V Leiden, proteins S and C, and antithrombine III\n6. Use of anticoagulant therapy (e.g., Coumadin, heparin)\n7. Uncontrolled hypertension - Elevated systolic pressure \\>150 or a diastolic blood pressure \\> 100\n8. Implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)\n9. Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma\n10. 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)\n11. Androgens or growth hormone within 6 months of enrollment and for study duration (topical physiologic androgen replacement will be permitted)\n12. Inability to abstain from smoking or vaping for duration of study\n13. Currently taking estrogen products (topical estrogen products will be permitted)\n14. Currently on weight loss diet or medication\n15. History of stroke with motor disability\n16. A recent history (\\\u003C12 months) of GI bleed\n17. History of liver disease or AST\u002FALT 2 times above the normal limit\n18. History of respiratory disease (acute upper respiratory infection, history of chronic lung disease)\n19. Any staff members who report directly to the principal investigators",true,"ALL","60 Years",{"count":81,"type":82},50,"ESTIMATED","INTERVENTIONAL",[85],"EARLY_PHASE1","A hallmark of aging is an impaired ability to adequately recover following a stressor, such as muscle disuse, resulting in muscle fibrosis and weakness thereby increasing the risk for falls and loss of independence. Mechanistic-based therapeutic strategies to enhance muscle recovery in older adults do not exist. Metformin has been implicated to have positive effects on muscle size and function through non-glycemic mechanisms. Metformin has been shown to enhance macrophage function and lessen cellular senescence burden by targeting SASP in a variety of muscle interstitial cells. However, the role of metformin to improve muscle recovery in older adults following disuse atrophy through immunomodulating and senomorphic mechanisms have not been examined. Therefore, the purpose of this study is to conduct a randomized, double blind, placebo-controlled clinical trial in older adult participants to determine if short-term metformin delivery (vs placebo) during the recovery phase following disuse atrophy can improve muscle regrowth.",[88],"Muscle Atrophy or Weakness","2025-12-01",{"date":91,"type":92},"2025-12-05","ACTUAL",{"date":94,"type":92},"2024-09-01",{"date":96,"type":82},"2030-05-31",{"name":5,"class":6},1]