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Recruiting EARLY_Phase 1 NCT06185179

Metformin and Muscle Recovery

Trial Parameters

Condition Muscle Atrophy or Weakness
Sponsor University of Utah
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 50
Sex ALL
Min Age 60 Years
Max Age N/A
Start Date 2024-09-01
Completion 2029-05-31
Interventions
MetforminPlacebo

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. Age between 60y and older 2. BMI: \<30 kg/m2 3. Good general medical health, ambulatory and in independent living setting 4. Adequate upper body strength to use assistive walking device (crutches, walker, etc) as assessed by PI/staff during screening 5. Clinical Frailty Scale score \< 3 6. Mini-Cog score \> 3 Exclusion Criteria: 1. History of cardiovascular disease (e.g., CHF, CAD, MI, CVA) 2. History of endocrine or metabolic disease such as hypo/hyperthyroidism and diabetes (Treated hypo/hyperthyroid for at least 6 months will be permitted) 3. History of kidney disease or failure (CKD \> stage 4; serum creatinine \>1.5mg/dL) 4. History of vascular disease 5. Risk of DVT including family history of thrombophilia, DVT, pulmonary emboli, myeloproliferative diseases including polycythemia (Hb\>18 g/dL) or thrombocytosis (platelets\>400x103/mL), and connective tissue diseases (positive lupus anticoagulant), hyperhomocystinemia, deficiencies of factor V Leiden, prote

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