The purpose of this study is to determine if ramipril and/or rosiglitazone retard the progression of atherosclerosis as evaluated by serial carotid intermedial thickness measurements.
Official Title
The Study of Atherosclerosis With Ramipril and Rosiglitazone.
Conditions
- Atherosclerosis
- Impaired Glucose Tolerance
- Isolated Impaired Fasting Glucose
- Cardiovascular Disease
Study Type
Interventional
Study Design
Prevention, Randomised, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study.
Further Details
Primary Outcome Measures:
- The change of the mean maximum carotid intimal medial thickness (IMT)evaluated across 12 segments involving the left and right common carotid, bifurcation and internal carotid arteries.
Secondary Outcome Measures:
- The change over time in the mean IMT across the common carotid far wall IMT of the right and the left carotid arteries.
Study Start
July 2001
Eligibility & Criteria
- Ages Eligible for Study: 30 years and older
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: Yes
Inclusion Criteria:
- Impaired glucose tolerance (FPG < 7 mmol/L or 126 mg/dL & 2hr PG between 7.8-11.0 mmol/l [140-199 mg/dl] after a 75 g OGTT
- Impaired glucose tolerance (FPG≥ 6.1 mmol/l [110 mg/dl]) and no diabetes (i.e. a FPG < 7.0 mmol/l [126 mg/dl])
- A technically adequate baseline carotid ultrasound examination
Exclusion Criteria:
- Current use of an ACE-inhibitor (ACE-I) or thiazolidinedione (TZD)
- Known hypersensitivity to ACE-I
- Prior use of anti-diabetic medications 9with the exception of during pregnancy)
- Use of systemic glucocorticoids or niacin
- Congestive heart failure or EF < 40%
- Existing cardiovascular disease (previous MI, stroke, angina, uncontrolled hypertension)
- Diabetes
- Renal or hepatic disease
- Major illness
- Use of another experimental drug
- Pregnant or unwilling to use reliable contraception
- Major psychiatric disorder
- Diseases that affect glucose tolerance
- Unwillingness to be randomized or sign informed consent
- Known uncontrolled substance abuse
- Inability to communicate with research staff
Total Enrolment
1200
Contact Details
Eva Lonn, MD
Hamilton Health Sciences
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