Metformin in Pre-diabetes Patients and Stroke study

This is an off-label, randomized, open blinded end-point study to determine the safety and tolerability of Metformin XR administration starting at 500mg daily to a maximum total daily dose of 1500mg XR daily on discharge in patients with pre-diabetes (defined as an HbA1c of 5.7-6.4%) admitted with a stroke. During an acute stroke admission or following a recent stroke admission, patients who are recruited into the trial will be randomized (in a 1:1 ratio) to either the active arm, receiving Metformin or usual care for a total of 4 months. Usual care for pre-diabetes includes advice on dietary and lifestyle improvements, advice of regular physical exercise and weight loss as well as advice on smoking cessation or avoidance. At baseline, we will record clinical and biochemical characteristics, cardiovascular risk factors and medication use. One month into the study, a phone call follow up will occur and participants in both groups will be asked to complete a side effect questionnaire and compliance determined. A second follow up phone call will occur at 2.5 months and participants will again be asked to complete the questionnaire and asked about compliance. Finally a physical study visit will be scheduled at four months following randomization. At this last visit, patients will complete the same questionnaire to determine their compliance and nature of any of the side-effects of the treatment. At both physical study visits, the fasting glucose levels, HbA1c, C-peptide, fasting lipid profile, blood pressure, urine albumin to creatinine ratio, body mass index (BMI), waist circumference, blood pressure, and lipid profile will be assessed. Questions regarding side effects and completion of the side effect questionnaire during both follow up phone calls and second physical visit will be performed with a blinded investigator.