IMIT-1: Lowering the Incidence of vascular complications with Metformin in patients with Impaired glucose tolerance and a recent TIA or minor ischemic stroke: a phase 2, randomized, controlled trial

Recruiting

• Conditions: glucose intolerancemetforminTIAstroke, ischemictrial

• Registration Number: NL-OMON26223
• Lead Sponsor: S.E. Vermeer, MD, PhD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Tolerability of metformin treatment (measured as number of patients still on treatment after 3 months);<br>2. The safety of metformin treatment (which will be continuously monitored) <br>3. The adjusted difference in 2-hour post-load glucose levels at 3 months.

Secondary Outcome Measures

Name	Time	Method
1. Differences in fasting glucose levels;<br>2. Insulin resistance;<br>3. Body mass index;<br>4. Percentage of patients with a normal glucose tolerance at 3 months.