Lifestyle Intervention Plus Metformin to Treat Frailty in Older Veterans With Obesity
Who is this study for? Older veterans with obesity
Status: Active_not_recruiting
Location: See location...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 85
Healthy Volunteers: t
View:
• BMI = or \> 30 kg/m2
• Stable body weight (plus/minus 2 kg) during the past 6 months
• Sedentary (regular exercise \<1 h/wk or \<2 x/wk for the last 6 months)
• Willing to provide informed consent
Locations
United States
Texas
Michael E. DeBakey VA Medical Center, Houston, TX
Houston
Time Frame
Start Date: 2021-05-14
Completion Date: 2027-09-30
Participants
Target number of participants: 114
Treatments
Experimental: Lifestyle Therapy plus Metformin
Diet-induced weight loss and Exercise Training plus Metformin 1500 mg daily
Placebo_comparator: Lifestyle Therapy plus Placebo
Diet-induced weight loss and Exercise Training plus Placebo
Active_comparator: Healthy lifestyle plus Metformin
Healthy lifestyle and Metformin 1500 mg daily
Authors
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development
Collaborators: Michael E. DeBakey VA Medical Center, Baylor College of Medicine