The Study of Atherosclerosis With Ramipril and Rosiglitazone

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gerstein, Hertzel, MD
• Collaborator: Heart and Stroke Foundation of Ontario
• Treatments: Ramipril; Rosiglitazone

Criteria

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