{ "data": { "asOf": "2026-10-30T22:24:59.909Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT02570672", "title": "Metformin for Preventing Frailty in High-risk Older Adults", "scientificTitle": "Metformin for Preventing Frailty in High-risk Older Adults", "status": "completed", "studyType": "interventional", "phase": [ "PHASE2" ], "conditions": [ "Frailty" ], "interventions": [ { "name": "Metformin", "type": "DRUG", "description": "Subjects will be randomized to metformin titrated to 1000mg twice daily as tolerated." }, { "name": "Placebo", "type": "DRUG", "description": "Subjects will randomized to placebo will receive placebo" } ], "sponsor": { "name": "The University of Texas Health Science Center at San Antonio", "type": "OTHER" }, "locations": [ { "city": "San Antonio", "country": "United States", "facility": "University of Texas Health Science Center at San Antonio" } ], "outcomes": { "other": [], "primary": [ "Fried Frailty Phenotype Criteria" ], "secondary": [ "Frailty Index Based on Deficit Accumulation" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* Men and women\n* All ethnic groups\n* Age 65 and older\n* Community-dwelling\n* 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\n* Subjects must have the following laboratory values: Hematocrit ≥ 33%, aspartate aminotransferase \\< 2 X upper limit of normal, alanine aminotransferase \\< 2 X upper limit of normal, alkaline phosphatase \\< 2 X upper limit of normal, normal urinalysis (no clinically significant white blood cells, red blood cells or bacteria), platelets ≥ 100,000, prothrombin time \\< 15 seconds and partial thromboplastin time \\< 40 seconds, glomerular filtration rate (GFR) ≥ 45ml/min and urine protein ≤ 100 mg/dL by lab urinalysis.\n\nExclusion Criteria:\n\n* Characterized as frail, defined as the presence of 3 or more of: 1) weak hand grip strength, 2) slow walking speed, 3) low physical activity, 4) unintentional weight loss of ≥ 10 pounds over the past year, 5) self-reported exhaustion\n* Resident of nursing home or long-term care facility\n* Subjects with diabetes with range fasting glucose in diabetes range (≥ 126 mg/dL), or 2-hour glucose within diabetes range on OGTT (≥ 200 mg/dL).\n* Subjects taking drugs known to affect glucose homeostasis\n* Untreated depression or Geriatric Depression Scale (GDS) score on 15-item scale \\>7\n* 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 \\<24, cognitive impairment due to any reason such that the patient is unable to provide informed consent.\n* History of moderate-severe heart disease (New York Heart Classification greater than grade II) or pulmonary disease (dyspnea on exertion upon climbing one flight of stairs or less; abnormal breath sounds on auscultation)\n* Poorly controlled hypertension (systolic \\>160 mmHg, diastolic \\>100 mmHg)\n* Peripheral arterial disease (history of claudication)\n* Moderate to severe valvular heart disease\n* Subjects who have been treated with long term (\\>30 days) systemic steroids, anabolic steroids, growth hormone or immunosuppresants within the last 6 months. 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