Carotid Atherosclerosis: MEtformin for Insulin ResistAnce Study

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Placebo; Drug: Metformin

• Registration Number: NCT00723307
• Lead Sponsor: Professor Naveed Sattar

Brief Summary

Hypothesis: Treatment with metformin in overweight non-diabetic individuals with coronary heart disease and on standard cardiovascular risk reducing agents including statins will have a beneficial impact on carotid artery atherosclerosis compared to placebo.

Rationale: Once subjects have a heart attack, they remain at much higher than average risk of another heart attack and stroke, despite the best current therapies to lower their cholesterol and blood pressure and thin their blood. Many subjects with heart disease also have problems metabolising (i.e. processing) sugar even if they do not have diabetes. There is some evidence that metformin, a drug which improves sugar metabolism, decreases the risk of future heart attacks in diabetic patients. However, whether metformin further reduces the risk of heart disease beyond established treatments in people without diabetes is unknown.

Method: The investigators will test the ability metformin, a drug with proven safety, to slow the progression of furring up (known as atherosclerosis) of blood vessels in non-diabetic subjects with heart disease. This will be achieved by treating 2 groups of subjects with metformin and placebo pills respectively. To measure atherosclerosis, the investigators will carry out ultrasound scans of the big blood vessels in the neck at the start of the study, after 1 year and after 1.5 years of therapy.The investigators will then be able to assess whether metformin has had a beneficial impact.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-24
• Study First Submitted QC: 2008-07-24
• Study First Posted: 2008-07-28
• Study Start: 2009-02
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-07
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

• Proven coronary heart disease (prior acute coronary syndrome, prior CABG or angiographically proven CHD)
• Aged 35-75 years
• Elevated waist circumference as per the International Diabetes Foundation criteria (94 cm in men and 80 cm in women)
• All patients will be on statin

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Exclusion Criteria

• Pregnancy and/or lactation at screening
• Premenopausal woman not on contraception
• Known or newly diagnosed diabetes mellitus on oral glucose tolerance testing (OGTT will be performed on subjects with HbA1C 6.0-6.9% and fasting plasma glucose [FPG] < 7.0 mmol/L at screening18)
• Screening results: HbA1C ≥ 7.0% and/or fasting plasma glucose ≥ 7.0 mmol/L
• Patients with Acute Coronary Syndrome within the last 3 months
• Clinically unstable heart failure
• Uncontrolled angina
• Contraindications to metformin

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Metformin	Metformin	-

Primary Outcome Measures

Name	Time	Method
Difference in progression of carotid intima-media thickness (measured in millimetres) between groups treated with metformin and placebo	1.5 years

Secondary Outcome Measures

Name	Time	Method
Difference in progression of carotid total plaque area (measured in square millimetres) between groups treated with metformin and placebo	1.5 years
Difference in progression of carotid total plaque volume (measured in cubic millimetres) between groups treated with metformin and placebo	1.5 years
Correlation of HbA1C, t-PA, CRP, IL-6, HOMA-IR and ICAM-1 with change in carotid IMT in metformin- and placebo-treated groups will be evaluated.	1.5 years

Trial Locations

Locations (1)

Glasgow Clinical Research Facility, NHS Greater Glasgow and Clyde; 🇬🇧 Glasgow, United Kingdom