IMIT-1: Lowering the Incidence of vascular complications with Metformin in patients with Impaired glucose Tolerance and a recent transient ischaemic attack or minor ischaemic stroke: a phase II randomised, controlled trial

Completed

• Conditions: Transient ischaemic attack or minor ischaemic stroke; Circulatory System; Vascular complications

• Registration Number: ISRCTN54960762
• Lead Sponsor: Erasmus Medical Centre (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-11
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Men or women 18 years and over
2. TIA/minor ischaemic stroke (modified Rankin Score three or less) within six months
3. Impaired fasting glucose (fasting glucose level of 5.6 to 6.9 mmol/L) and/or impaired glucose tolerance (two-hour post-load glucose level of 7.8 to 11.0 mmol/L)
4. Informed consent

Exclusion Criteria

1. Known or newly diagnosed diabetes mellitus
2. Contraindication for metformin:
2.1. Renal impairment (serum creatinine greater than 135 micromol/L for men, and greater than 110 micromol/L for women)
2.2. Hepatic disease (liver enzymes increased twice the upper limit of normal)
2.3. A past history of lactic acidosis
2.4. Cardiac failure requiring pharmacological therapy
2.5. Chronic hypoxic lung disease
2.6. Pregnancy
2.7. Breast feeding
3. Severe comorbidity interfering with follow-up

Study & Design

• Study Type: Interventional
• Study Design: Not specified