IMIT: 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

Phase 2

Recruiting

• Conditions: impaired glucose tolerance; prediabetes; 10018424; 10007963

• Registration Number: NL-OMON30741
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

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

Inclusion Criteria

-Age > 18 years
-TIA/minor ischemic stroke < 6 months
-Non-diabetics with impaired glucose tolerance (2hr post-load glucose 7.8-11.0 mmol/L) or impaired fasting glucose (fasting glucose 5.6-6.9 mmol/L)

Exclusion Criteria

-Diabetes mellitus
-Dependency of others (mRankin >= 4)
-Contraindication metformin (severe renal failure, severe hepatic insufficiency, severe heart failure, severe hypoxic lung disease, lactic acidosis in history)
-Severe comorbidity interfering with follow-up

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcomes of this phase 2 trial will be the safety, and tolerability<br /><br>of metformin treatment and the adjusted difference in 2-hour post-load glucose<br /><br>levels at 3 months between treatment groups. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will be the difference in fasting glucose levels, insulin<br /><br>resistance, body mass index, and percentage of patients with a normal glucose<br /><br>tolerance after 3 months.</p><br>