Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 14, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT04221750). This is a study registration, not published results. Lead sponsor: VA Office of Research and Development. Recruitment status: COMPLETED. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 114 participants (ACTUAL). Conditions: Frailty, Sarcopenic Obesity, Aging. Interventions: BEHAVIORAL: Lifestyle therapy; DRUG: Metformin Hydrochloride; DRUG: Placebo; BEHAVIORAL: Healthy Lifestyle. Primary outcome measures: Change in the Modified Physical Performance Test (PPT) , 6 months. Brief summary: The continuing increase in prevalence of obesity in older adults including many older Veterans has become a major health concern. The clinical trial will test the central hypothesis that a multicomponent intervention consisting of lifestyle therapy (diet-induced weight loss and exercise training) plus metformin will be the most effective strategy for reversing sarcopenic obesity and frailty in older Veterans with obesity.