Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors

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.

Conditions

• Frailty
• Sarcopenic Obesity
• Aging

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

Sponsors & Collaborators

• Michael E. DeBakey VA Medical Center

  collaborator FED

• Baylor College of Medicine

  collaborator OTHER

• VA Office of Research and Development

  lead FED

Principal Investigators

• Dennis T Villareal, MD · Michael E. DeBakey VA Medical Center, Houston, TX

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-14

Primary Completion

2025-07-31

Completion

2025-07-31

FDA Drug

Yes

Countries

• United States

Study Locations