Metformin and Muscle Recovery

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Utah

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Metformin

    Drug

    Metformin will be distributed in 500mg pills.

  • Placebo

    Other intervention

    Placebo will be distributed in pill form

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: MetforminExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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