Phase 2
N=141
Metformin for Preventing Frailty in High-risk Older Adults
Frailty
Bottom Line
View on ClinicalTrials.gov: NCT02570672 ↗Enrolled (actual)
141
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Frailty Index Based on Deficit Accumulation — -0.0002; 0.0002 Index score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Metformin (Drug); Placebo (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frailty Index Based on Deficit Accumulation |
-0.0002; 0.0002 | — |
| PRIMARY Fried Frailty Phenotype Criteria |
0.0289; 0.0164 | — |
Summary
Frailty is a geriatric syndrome which leads to poor health outcomes in older adults, such as falls, disability, hospitalization, institutionalization, and death. Due to the dramatic growth in the U.S. aging population and the health care costs associated with frailty (estimated at more than $18 billion per year), frailty is a major health care problem. There has been little research into potential pharmacologic interventions that would delay or reduce the incidence of frailty. Thus, the major goal of this study is to test metformin as a novel intervention for the prevention of frailty. The investigators propose that diabetes/insulin resistance and inflammation are major contributors to frailty, and that the use of metformin to modulate diabetes/insulin resistance and inflammation will prevent and/or ameliorate the progression of frailty.
Eligibility Criteria
Inclusion Criteria
- Men and women
- All ethnic groups
- Age 65 and older
- Community-dwelling
- Pre-diabetic based on oral glucose tolerance test with 2 hour values of 140 - 199 mg/dL after an oral glucose load, and no diagnosis of diabetes in the past 12 months
- Subjects must have the following laboratory values: Hematocrit ≥ 33%, aspartate aminotransferase 7
- Diagnosis of any disabling neurologic disease Parkinson's Disease, Amyotrophic Lateral Sclerosis, multiple sclerosis, cerebrovascular accident with residual deficits (muscle weakness or gait disorder), severe neuropathy, diagnosis of dementia or Mini-mental State Exam (MMSE) score 160 mmHg, diastolic >100 mmHg)
- Peripheral arterial disease (history of claudication)
- Moderate to severe valvular heart disease
- Subjects who have been treated with long term (>30 days) systemic steroids, anabolic steroids, growth hormone or immunosuppresants within the last 6 months. Males with a medical history of testosterone deficiency who are on a stable dose of testosterone replacement (for ≥ 3 months) are allowed.
- Subjects who have been treated with short term (<30 days) systemic steroids, anabolic steroids, growth hormone or immunosuppressants within the last 1 month.
- Chronic inflammatory condition, autoimmune disease, or infectious processes (e.g., active tuberculosis, Human Immunodeficiency Virus, rheumatoid arthritis, systemic lupus erythematosus, acute or chronic hepatitis B or C)
- Active tobacco use (within 6 months)
- Illicit drug use
- Active malignancy, non-skin
- Disease or condition likely to cause death within 5 years
- Hypersensitivity to metformin or pioglitazone
- Any disease or condition considered to be exclusionary based on the clinical opinion and discretion of the PI
Data sourced from ClinicalTrials.gov (NCT02570672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.