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| Sponsor: | University of Glasgow |
|---|---|
| Collaborators: |
NHS Greater Glasgow and Clyde Chief Scientist Office of the Scottish Government |
| Information provided by: | University of Glasgow |
| ClinicalTrials.gov Identifier: | NCT00723307 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: Metformin Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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: | 200 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Metformin |
Drug: Metformin
White film-coated tablets, 850mg tablet twice daily, 1.5 years duration
Other Names:
|
| Placebo Comparator: Placebo |
Drug: Placebo
White coated tablet; one tablet twice daily; 1.5 years duration
Other Name: Dummy pill
|
Eligibility| Ages Eligible for Study: | 35 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United Kingdom | |
| Glasgow Clinical Research Facility, NHS Greater Glasgow and Clyde | |
| Glasgow, United Kingdom, G11 6NT | |
| Principal Investigator: | Naveed Sattar, PhD | University of Glasgow |
More Information
| Responsible Party: | Professor Naveed Sattar, University of Glasgow, BHF Glasgow Cardiovascular Research Centre |
| ClinicalTrials.gov Identifier: | NCT00723307 History of Changes |
| Other Study ID Numbers: | Gla-Met-1 (version 5) |
| Study First Received: | July 24, 2008 |
| Last Updated: | August 17, 2011 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
No diabetes mellitus Elevated waist circumference |
|
Atherosclerosis Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease Insulin Resistance Carotid Artery Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Heart Diseases |
Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |