Using Metformin to Improve Muscle Recovery in Older Adults

Use of Metformin to Improve Muscle Regrowth in Older Adults

This study is testing if metformin can help older adults recover their muscle strength and function after losing muscle due to inactivity.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: University of Utah (Academic / other)
• Locations: 1 site (Salt Lake City, Utah)
• Trial ID: NCT06185179 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of metformin on muscle recovery in older adults who have experienced muscle disuse atrophy. It aims to determine whether short-term metformin treatment can enhance muscle regrowth and function by improving macrophage activity and reducing cellular senescence. The study is designed as a randomized, double-blind, placebo-controlled trial, focusing on older adults aged 60 and above who are in good health and able to ambulate independently. The ultimate goal is to develop effective therapeutic strategies to combat muscle weakness and promote recovery in the aging population.

Who should consider this trial

Good fit: Ideal candidates for this study are older adults aged 60 and above, with a BMI under 30, who are generally healthy and able to ambulate independently.

Not a fit: Patients with a history of cardiovascular, endocrine, or kidney diseases, or those at risk for deep vein thrombosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatments that enhance muscle recovery and reduce the risk of falls and disability in older adults.

How similar studies have performed: While metformin has been explored for various age-related conditions, this specific application for muscle recovery in older adults is novel and has not been extensively tested.

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, proteins S and C, and antithrombine III
6. Use of anticoagulant therapy (e.g., Coumadin, heparin)
7. Uncontrolled hypertension - Elevated systolic pressure \>150 or a diastolic blood pressure \> 100
8. Implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)
9. Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma
10. Chronic systemic corticosteroid use (≥ 2 weeks) within 4 weeks of enrollment and for study duration (intra-articular/topical/inhaled therapeutic or physiologic doses of corticosteroids will be permitted)
11. Androgens or growth hormone within 6 months of enrollment and for study duration (topical physiologic androgen replacement will be permitted)
12. Inability to abstain from smoking or vaping for duration of study
13. Currently taking estrogen products (topical estrogen products will be permitted)
14. Currently on weight loss diet or medication
15. History of stroke with motor disability
16. A recent history (\<12 months) of GI bleed
17. History of liver disease or AST/ALT 2 times above the normal limit
18. History of respiratory disease (acute upper respiratory infection, history of chronic lung disease)
19. Any staff members who report directly to the principal investigators

Where this trial is running

Salt Lake City, Utah

• University of Utah — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Principal investigator: Micah Drummond — University of Utah
• Study coordinator: Micah Drummond

Conditions Muscle Atrophy or Weakness