glucose intolerance metformin TIA stroke, ischemic trial
Conditions
Interventions
Patients will be randomized for metformin or no oral antidiabetic drug (open-label) on top of optimal standard treatment, including lifestyle advice aimed at weight reduction and regular physical exer
Sponsors
S.E. Vermeer, MD, PhD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men or women 18 years and over; 2. TIA/minor ischemic stroke (modified Rankin Score 3 or less) within 6 months; 3. Impaired fasting glucose (fasting glucose level of 5.6 to 6.9 mmol/L) and/or impaired glucose tolerance (2-hour post-load glucose level of 7.8 to 11.0 mmol/L); 4. Informed consent
Exclusion criteria
Exclusion criteria: 1. Known or newly diagnosed diabetes mellitus; 2. Contraindication for metformin: a. renal impairment (serum creatinine >135 micromol/L for men, and >110 micromol/L for women), b. hepatic disease (liver enzymes increased twice the upper limit of normal), c. a past history of lactic acidosis, d. cardiac failure requiring pharmacological therapy, e. chronic hypoxic lung disease, f. pregnancy, g. breast feeding; 3. Severe comorbidity interfering with follow-up
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Differences in fasting glucose levels; 2. Insulin resistance; 3. Body mass index; 4. Percentage of patients with a normal glucose tolerance at 3 months. | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Tolerability of metformin treatment (measured as number of patients still on treatment after 3 months); 2. The safety of metformin treatment (which will be continuously monitored) 3. The adjusted difference in 2-hour post-load glucose levels at 3 months. | — |
Contacts
Public ContactTrial office - Section of Neurovascular Diseases
Erasmus MC Room Ee 22.42
Outcome results
None listed