A 52 week double blind randomized controlled trial comparing the effect of Rosiglitazone versus Placebo on the prevention of progression of atherosclerosis in high risk patients without diabetes.
Completed
- Conditions
- Metabolic Syndrome
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 116
Inclusion Criteria
1. Males;
2. Age: males>=50 years;
Exclusion Criteria
1. Severe obesity (BMI>35 kg/m2);
2. Diabetes type 2 defined as fasting venous plasma glucose >7.0 mmol/L, or HbA1c >6.5%;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Magnetic resonance (MR) assessment of the carotid artery wall, MR-measured hepatic, intra-abdominal and peripheral subcutaneous fat stores.
- Secondary Outcome Measures
Name Time Method 1. Assessment of the changes in selected inflammatory and metabolic parameters amongst which changes in insulin resistance & iNOS;<br /><br>2. Cross sectional assessment of the relation between the characteristics of the Magnetic Resonance image of the carotid arterial wall and Circulating Endothelial Progenitor cells;<bR><br>3. The effect of Rosiglitazone on CEPs after one year of treatment in subjects with high cardiovascular risk without diabetes mellitus; <bR><br>4. Optimalisation of MR assessment of (complex) atherosclerotic plaques & other cardiovascular risk markers.