Metformin and Muscle Recovery

NCT06185179 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 086328
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• % recovery of thigh muscle volume (TMV)

  recovery of thigh muscle volume will be defined as the percentage of TMV at recovery when comparing to the TMV immobilization time point ((TMV recovery - TMV immobilization)/TMV immobilization)\*100. Thigh muscle volume will be determined by MRI.

  Thigh muscle volume will be determined at 14 days of single leg immobilization and at 14 days of recovery.

Study Arms (2)

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/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.

Drug: Metformin

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.

Other: Placebo

Interventions

Metformin DRUG

Metformin will be distributed in 500mg pills.

Also known as: Glucophage, Fortamet, Glumetza, Riomet

Metformin

Placebo OTHER

Placebo will be distributed in pill form

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)
• Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma
• 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)
• Androgens or growth hormone within 6 months of enrollment and for study duration (topical physiologic androgen replacement will be permitted)
• Inability to abstain from smoking or vaping for duration of study
• Currently taking estrogen products (topical estrogen products will be permitted)
• Currently on weight loss diet or medication
• History of stroke with motor disability

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Muscular Atrophy; Asthenia

Interventions

Metformin

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Micah Drummond

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Micah Drummond

CONTACT

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

Rebekah Drummond

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Metformin and Placebo pills will be encapsulated by the pharmacy in order to protect treatment assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Physical Therapy and Athletic Training

Model Details: 2-weeks single leg immobilization followed by 2-weeks of recovery

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 29, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2030
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)