Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors

Part of paid clinical trials in Houston, Texas.

Sponsor
VA Office of Research and Development
Study ID
NCT04221750
Phase
PHASE3
Status
Completed

Conditions

  • Aging
  • Frailty
  • Sarcopenic Obesity

Eligibility Criteria

Sex
ALL
Age
65 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Lifestyle therapy — BEHAVIORAL
    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 — DRUG
    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 — DRUG
    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 — BEHAVIORAL
    Group educational sessions that focus on healthy diet, exercise, and social support once a month

Study Details

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.

Key Dates

Start date
May 14, 2021
Status verified
Dec 2025
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
114 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Change in the modified Physical Performance Test (PPT) [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Michael E. DeBakey VA Medical Center, Houston, TXHoustonTexas77030-4211-

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By research site
Michael E. DeBakey VA Medical Center, Houston, TX· Houston, TX

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