Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

May 14, 2021

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2027

Conditions
FrailtySarcopenic ObesityAging
Interventions
BEHAVIORAL

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

DRUG

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.

DRUG

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.

BEHAVIORAL

Healthy Lifestyle

Group educational sessions that focus on healthy diet, exercise, and social support once a month

Trial Locations (1)

77030-4211

Michael E. DeBakey VA Medical Center, Houston, TX, Houston

All Listed Sponsors
collaborator

Michael E. DeBakey VA Medical Center

FED

collaborator

Baylor College of Medicine

OTHER

lead

VA Office of Research and Development

FED