Metformin and Muscle Recovery (NCT06185179) | Clinical Trial Compass
RecruitingEarly Phase 1
Metformin and Muscle Recovery
United States50 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range60 Years
SexALL
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Inclusion criteria
✓. Age between 60y and older
✓. BMI: \<30 kg/m2
✓. Good general medical health, ambulatory and in independent living setting
✓. Adequate upper body strength to use assistive walking device (crutches, walker, etc) as assessed by PI/staff during screening
✓. Clinical Frailty Scale score \< 3
✓. Mini-Cog score \> 3
Exclusion criteria
✕. 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 kidney disease or failure (CKD \> stage 4; serum creatinine \>1.5mg/dL)
✕. History of vascular disease
What they're measuring
1
% recovery of thigh muscle volume (TMV)
Timeframe: Thigh muscle volume will be determined at 14 days of single leg immobilization and at 14 days of recovery.
. 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, proteins S and C, and antithrombine III
✕. Use of anticoagulant therapy (e.g., Coumadin, heparin)
✕. Uncontrolled hypertension - Elevated systolic pressure \>150 or a diastolic blood pressure \> 100