Phase 2
N=120
Metformin and Muscle in Insulin-resistant Older Veterans
Prediabetes
Bottom Line
View on ClinicalTrials.gov: NCT01804049 ↗Enrolled (actual)
120
Serious AEs
64.2%
Results posted
Feb 2020
Primary outcome: Primary: Change in Total Lean Mass From Baseline — 322.8; 697.6; 392.4; 548.0 grams lean mass — p=0.45
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- metformin (Drug); placebo (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Lean Mass From Baseline |
322.8; 697.6; 392.4; 548.0 | 0.45 |
| SECONDARY Change in Physical Performance - 400 Meter Walk Speed |
-2.82; 0.46 | 0.48 |
| SECONDARY Change in Muscle Characteristics |
— | — |
Summary
Sarcopenia is the loss of muscle mass, strength and function with aging and is associated with increased disability, falls and fractures. Older adults with diabetes and prediabetes are insulin resistant and have a higher risk of developing sarcopenia. This study examines the use of metformin, an antidiabetic drug, for preventing the development of sarcopenia in older adults with prediabetes.
Eligibility Criteria
Inclusion Criteria
- The investigators will enroll 120 sedentary, weight-stable, ambulatory Veterans aged 65 years and older with prediabetes identified with fasting glucose values 100 mg/dL or greater but under 126 mg/dL with no use of diabetes medications.
- Participants must demonstrate that they are able to ambulate 400 meters without assistance.
Exclusion Criteria
- Chronic medical conditions affecting muscle mass or function like active non-skin cancer and hypogonadism
- Medications affecting muscle mass or function like glucocorticoids and androgen/antiandrogens
- Contraindications to metformin such as renal dysfunction defined as creatinine >= 1.5 mg/dL for men or >=1.4 mg/dL for women or estimated glomerular filtration rate (eGFR) 48 U/L, aspart aminotransferase (AST)>41 U/L or alkaline phosphatase (AlkPhos)>141 U/L; B12 deficiency defined as B12 level 1.2 or activated partial thromboplastin time (aPTT)>36 seconds
- Allergy to lidocaine
Data sourced from ClinicalTrials.gov (NCT01804049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.