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This study investigated how the drug Metformin, compared with placebo, affects mitochondria-related gene expression levels in platelets of people with prediabetes (a pre-diabetes condition). It enrolled people aged 18 and older with a body mass index above 25 and blood sugar values in the prediabetic range. It was conducted in Phase 1 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * age≥18 years * BMI\>25 kg/m2 * fasting plasma glucose 100-125 mg/dL, AND/OR Hemoglobin-A1C between 5.5 and 6.4%, AND/OR post-load glucose between 140 and 199 mg/dL on a 2-hour Oral Glucose Tolerance Test (OGTT) * All inclusion criteria will be checked on participants' first in-person visits. Exclusion Criteria: * unwilling to accept treatment assignment by randomization * participation in another clinical research trial * history of myocardial infarction or stroke * significant arrhythmia (e.g. atrial fibrillation) * active thromboembolic disease * inflammatory bowel disease * serum creatinine levels greater than or equal to 1.5 mg/dL in males or greater than or equal to 1.4 mg/dL in females * known hypersensitivity to metformin hydrochloride or any of its components * acute or chronic metabolic acidosis * inability to participate in lifestyle modifications * pregnancy; other glucose-lowering or diabetic therapy * systemic glucocorticoids * prescription weight loss medications * or otherwise deemed unsuitable by study investigators (e.g. unable to complete follow-up visits, alcohol abuse, etc).