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