Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors

Completed · Phase 3 · Has a placebo group

Conditions studied: Frailty, Sarcopenic Obesity, Aging

In brief

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 facts

Study ID: NCT04221750
Run by: VA Office of Research and Development
People needed: 114
Starts: 2021-05-14
Expected to finish: 2025-07-31
Last updated by the study team: 2026-01-05

Who can join

Age: 65 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Age 65 - 85 years
BMI = or > 30 kg/m2
Mild to moderate frailty (score of 18 to 31 in the modified Physical Performance Test)
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

You may not qualify if…

Any major chronic diseases, or any condition that would interfere with exercise or dietary restriction, or use of metformin, in which exercise, dietary restrictions, or metformin are contraindicated, or that would interfere with interpretation of results
Cardiopulmonary disease (e.g. recent MI, unstable angina, stroke) or unstable disease (e.g., NYHA Class III or IV congestive heart failure, severe pulmonary disease requiring steroid pills or the use of supplemental oxygen) that would contraindicate exercise or dietary restriction
Severe orthopedic (e.g. awaiting joint replacement) and/or neuromuscular (e.g. multiple sclerosis, active rheumatoid arthritis) disease or impairments that would contraindicate participation in exercise
Renal impairment as defined by an estimated glomerular filtration rate (eGFR of less than 30 mL/min/1.73 m2) in which metformin is contraindicated
Other significant co-morbid disease that would impair ability to participate in the exercise intervention (e.g. severe psychiatric disorder [e.g. bipolar, schizophrenia], excess alcohol use [>14 drinks per week])
Severe visual or hearing impairments that would interfere with following directions
Significant cognitive impairment, defined as a known diagnosis of dementia or positive screening test for dementia using the Mini-Mental State Exam (i.e. MMSE score <24)69
Uncontrolled hypertension (BP>160/90 mm Hg)
History of malignancy during the past 5 years (except non-melanoma skin cancers)
Current use of bone acting drugs (e.g. use of estrogen, or androgen containing compound,raloxifene, calcitonin, parathyroid hormone during the past year or bisphosphonates during the last two years)
Osteoporosis (T-score -2.5 and below on hip or spine scan) or history of fragility fractures
Known history of diabetes mellitus or any of the following:
Fasting blood glucose of 126 mg/dl, or HbA1c of 6.5% or >
Terminal illness with life expectancy less than 12 months, as determined by a physician
Use of any drugs or natural products designed to induce weight loss within past three months
History of excessive alcohol consumption (e.g. 8 or more drinks a week for women and 15 or more drinks a week for men)
Positive exercise stress test for ischemia or any indication for early termination of exercise stress testing
Taking metformin or any other glucose lowering drug
Lives outside of the study site or is planning to move out of the area in the next 2 years

Where it is running

Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States

Full record on ClinicalTrials.gov

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