A 52 week double blind randomised 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, atherosclerosis; Atherosclerosis; Circulatory System

• Registration Number: ISRCTN54951661
• Lead Sponsor: eiden University Medical Centre (LUMC) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 116

Inclusion Criteria

1. Males
2. Age: males greater than or equal to 50 years
3. Visceral obesity as determined by Wcr: males: greater than 94 cm
4. Two other metabolic syndrome criteria (According to IDF criteria 2005) and/or a positive family history for cardiovascular disease (coronary heart disease [CHD] and/or peripheral arterial disease [PAD] in first degree family member: males less than 55 years; females less than 60 years)
5. CRP greater than 1.8 mg/L
6. Subject who is willing and is able to provide a signed and dated written informed consent

Exclusion Criteria

1. Severe obesity (body mass index [BMI] greater than 35 kg/m^2)
2. Diabetes type 2 defined as fasting venous plasma glucose greater than 70 mmol/L, or HbA1c greater than 65%
3. Primary dyslipidaemia
4. A previous cardiovascular event, including Q-wave infarction on electrocardiography (ECG)
5. QTc time interval on baseline ECG greater than 450 ms
6. Heart failure New York Heart Association (NYHA) class I or higher
7. Hypoglycaemia
8. Presence of clinically significant hepatic disease (i.e., subjects with alanine aminotransferase [ALT], total bilirubin, or alkaline phosphatase greater than 25 times the upper limit of the normal laboratory range)
9. Subjects with creatinine clearance less than 40 mL/min calculated using the Cockcroft-Gault equation adjusted for ideal body weight
10. Contraindication for magnetic resonance imaging (MRI)-assessments
11. Risk of non-compliance

Study & Design

• Study Type: Interventional
• Study Design: Not specified