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Completed NCT04221750

Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors

Conditions: Frailty, Sarcopenic Obesity, Aging

Sex: All
Ages: 65 Years – 85 Years
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 114
Sponsor: VA Office of Research and Development

Location: Michael E. DeBakey VA Medical Center, Houston, TX Houston Texas

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.

Eligibility Criteria

Inclusion Criteria: * Age 65 - 85 years * BMI = or \> 30 kg/m2 * Mild to moderate frailty (score of 18 to 31 in the modified Physical Performance Test) * Stable body weight (plus/minus 2 kg) during the past 6 months * Sedentary (regular exercise \ * Terminal illness with life expectancy less than 12 months, as determined by a physician * Use of any drugs or natural products designed to induce weight loss within past three months * History of excessive alcohol consumption (e.g. 8 or more drinks a week for women and 15 or more drinks a week for men) * Positive exercise stress test for ischemia or any indication for early termination of exercise stress testing * Taking metformin or any other glucose lowering drug * Lives outside of the study site or is planning to move out of the area in the next 2 years

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04221750). StuddyBuddy aggregates publicly available trial information.