Recruiting
Early Phase 1

Metformin

Sponsor:

University of Utah

Code:

NCT06185179

Conditions

Muscle Atrophy or Weakness

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

Metformin

Placebo

Study Details

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.

Conditions

Muscle Atrophy or Weakness

Study ID

NCT06185179

Start date

Sep 1, 2024

Status verified date

Dec, 2025

Completion date

May 31, 2030

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Metformin

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/day. 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.

placebo comparator: Placebo

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.

Interventions

Metformin

Metformin will be distributed in 500mg pills.

Placebo

Placebo will be distributed in pill form

Primary outcome measure

  • % recovery of thigh muscle volume (TMV) [ Time Frame: Thigh muscle volume will be determined at 14 days of single leg immobilization and at 14 days of recovery. ]

Central Contacts and Locations

Central contacts

Micah Drummond

801-213-2737micah.drummond@hsc.utah.edu

Rebekah Drummond

801-839-4534u6044729@umail.utah.edu

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Micah Drummond, PhD

8012132737micah.drummond@hsc.utah.edu

Rebekah Drummond

8018394524rebekah.drummond@hsc.utah.edu

More Information

Sponsor

University of Utah

Last update posted

Dec 5, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2025-12-05.