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Sponsors and Collaborators: |
University of Glasgow NHS Greater Glasgow and Clyde Chief Scientist Office |
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Information provided by: | University of Glasgow |
ClinicalTrials.gov Identifier: | NCT00723307 |
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: We 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, we will carry out ultrasound scans of the big blood vessels in the neck at the start of the study, after 1 year and after 2 years of therapy.We will then be able to assess whether metformin has had a beneficial impact.
Condition | Intervention | Phase |
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Coronary Artery Disease |
Drug: Metformin Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomised Placebo-Controlled Trial of Metformin on Progression of Carotid Atherosclerosis in Non-Diabetic Patients With Cardiovascular Disease Treated With Conventional Risk Reducing Agents |
Estimated Enrollment: | 400 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Metformin
White film-coated tablets, 850mg tablet twice daily, 2 years duration
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2: Placebo Comparator |
Drug: Placebo
White coated tablet; one tablet twice daily; 2 years duration
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Ages Eligible for Study: | 35 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Naveed Sattar, PhD | +44 141 3303419 | nsattar@clinmed.gla.ac.uk |
United Kingdom | |
Glasgow Clinical Research Facility, NHS Greater Glasgow and Clyde | |
Glasgow, United Kingdom, G11 6NT |
Principal Investigator: | Naveed Sattar, PhD | University of Glasgow |
Responsible Party: | University of Glasgow, BHF Glasgow Cardiovascular Research Centre ( Professor Naveed Sattar ) |
Study ID Numbers: | Gla-Met-1 |
Study First Received: | July 24, 2008 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00723307 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
No diabetes mellitus Elevated waist circumference |
Atherosclerosis Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Metformin Diabetes Mellitus Disease Progression Vascular Diseases Central Nervous System Diseases |
Arteriosclerosis Ischemia Brain Diseases Cerebrovascular Disorders Insulin Coronary Disease Insulin Resistance Carotid Artery Diseases Coronary Artery Disease |
Hypoglycemic Agents Physiological Effects of Drugs Nervous System Diseases Cardiovascular Diseases Pharmacologic Actions |