114
Participants
Start Date
May 14, 2021
Primary Completion Date
September 30, 2026
Study Completion Date
September 30, 2027
Lifestyle therapy
Weight management program, in which participants are prescribed a balanced diet that provides and energy deficit of 500 to 750 kcal per day to induced \~10% weight loss plus Supervised combined aerobic and resistance exercise training three times weekly
Metformin Hydrochloride
Given orally starting at 500 mg (one tablet) taken orally once a day with meals. After a week, the dose of metformin will be increased to 1000 mg (two tablets) daily. After another week, the dose of metformin will be increased to 1500 mg (three tablets) daily.
Placebo
Given orally starting at 500 mg (one tablet) taken orally once a day with meals. After a week, the dose of placebo will be increased to 1000 mg (two tablets) daily. After another week, the dose of placebo will be increased to 1500 mg (three tablets) daily.
Healthy Lifestyle
Group educational sessions that focus on healthy diet, exercise, and social support once a month
Michael E. DeBakey VA Medical Center, Houston, TX, Houston
Michael E. DeBakey VA Medical Center
FED
Baylor College of Medicine
OTHER
VA Office of Research and Development
FED