Status:
COMPLETED
Carotid Atherosclerosis: MEtformin for Insulin ResistAnce Study
Lead Sponsor:
Professor Naveed Sattar
Collaborating Sponsors:
NHS Greater Glasgow and Clyde
Chief Scientist Office of the Scottish Government
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
35-75 years
Phase:
PHASE4
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 imp...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT00723307
Start Date
February 1 2009
End Date
December 1 2012
Last Update
December 11 2012
Active Locations (1)
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1
Glasgow Clinical Research Facility, NHS Greater Glasgow and Clyde
Glasgow, United Kingdom, G11 6NT