The Study of Atherosclerosis with Ramipril and Rosiglitazone

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