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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