Carotid Atherosclerosis: MEtformin for Insulin ResistAnce Study
NCT ID: NCT00723307
Last Updated: 2012-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
173 participants
INTERVENTIONAL
2009-02-28
2012-12-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Metformin
Metformin
White film-coated tablets, 850mg tablet twice daily, 1.5 years duration
Placebo
Placebo
White coated tablet; one tablet twice daily; 1.5 years duration
Interventions
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Metformin
White film-coated tablets, 850mg tablet twice daily, 1.5 years duration
Placebo
White coated tablet; one tablet twice daily; 1.5 years duration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
35 Years
75 Years
ALL
No
Sponsors
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NHS Greater Glasgow and Clyde
OTHER
Chief Scientist Office of the Scottish Government
OTHER_GOV
Professor Naveed Sattar
OTHER
Responsible Party
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Professor Naveed Sattar
Professor of Metabolic Medicine
Principal Investigators
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Naveed Sattar, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Glasgow
Locations
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Glasgow Clinical Research Facility, NHS Greater Glasgow and Clyde
Glasgow, , United Kingdom
Countries
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References
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Preiss D, Welsh P, Sattar N. Metformin Therapy and Circulating NT-proBNP Levels: The CAMERA Trial. Diabetes Care. 2016 Aug;39(8):e114-5. doi: 10.2337/dc16-0887. Epub 2016 Jun 6. No abstract available.
Preiss D, Lloyd SM, Ford I, McMurray JJ, Holman RR, Welsh P, Fisher M, Packard CJ, Sattar N. Metformin for non-diabetic patients with coronary heart disease (the CAMERA study): a randomised controlled trial. Lancet Diabetes Endocrinol. 2014 Feb;2(2):116-24. doi: 10.1016/S2213-8587(13)70152-9. Epub 2013 Nov 7.
Other Identifiers
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Gla-Met-1 (version 5)
Identifier Type: -
Identifier Source: org_study_id