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 - CAMERA: Carotid Atherosclerosis: MEtformin for insulin ResistAnce study
- Conditions
- Participants must have definite coronary heart disease: either a previous myocardial infarction or positive findings on coronary angiogram. They can have normal glucose tolerance, impaired fasting glycaemia or impaired glucose tolerance but must not be diabetic. Participants will also be overweight as defined by a waist circumference >80cm in women and >94cm in men.MedDRA version: 9.1 Level: LLT Classification code 10051615 Term: Atherosclerotic cardiovascular disease
- Registration Number
- EUCTR2008-002169-30-GB
- Lead Sponsor
- Greater Glasgow Health Board, Research and Development Department
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 220
oProven coronary heart disease (prior acute coronary syndrome, prior coronary artery bypass graft or angiographically proven coronary heart disease)
oAged 35-75 years
oElevated waist circumference as per the International Diabetes Foundation criteria (94cm in men and 80cm in women)
oAttending Cardiology outpatient clinics at Glasgow Royal Infirmary, the Western Infirmary, Stobhill Hospital and Royal Alexandra Hospital ; and patients identified at volunteering GP surgeries in Glasgow as approved by the Scottish Primary Care Research Network
oAll patients will be on statin medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
oPregnancy and/or lactation at screening
oPremenopausal woman not on adequate contraception (defined as daily oral hormonal contraception or regular injectable hormonal contraception)
oKnown 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 <7.0mmol/L at screening)
oScreening results: HbA1C =7.0% and/or fasting plasma glucose =7.0mmol/L
oPatients with acute coronary syndrome within the last 3 months
oStage 3 or 4 heart failure defined according to the New York Heart Association criteria
oUncontrolled angina
oContraindications to metformin (example hepatic impairment, renal impairment [eGFR <45 mL/min/1.73m2 at screening], known hypersensitivity to metformin, acute illness [dehydration, severe infection, shock, acute cardiac failure]), and suspected tissue hypoxia will be excluded.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method