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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24183

Enrollment

116

Registered

2005-09-09

Start date

2005-09-26

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Interventions

1. Lifestyle intervention

2. Rosiglitazone 8 mg (4 mg bd) versus placebo.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Males; 2. Age: males>=50 years; 3. Visceral obesity as determined by Wcr: males: >94cm; 4. Two other metabolic syndrome criteria (According to IDF criteria 2005) and/or a positive family history for cardiovascular disease (CHD and/or PAD in first degree family member: male 1.8 mg/L; 6. Subject who is willing and is able to provide a signed and dated written informed consent.

Exclusion criteria

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%; 3. Primary dyslipidemia; 4. A previous cardiovascular event, including Q-wave infarction on electrocardiography (ECG); 5. QTc time interval on baseline ECG > 450ms; 6. Heart failure NYSE class I or higher; 7. Hypoglycaemia; 8. Presence of clinically significant hepatic disease (i.e. subjects with ALT, total bilirubin, or alkaline phosphatase > 2.5 times the upper limit of the normal laboratory range); 9. Subjects with creatinine clearance < 40 mL/min calculated using the Cockcroft-Gault equation adjusted for ideal body weight; 10. Contraindication for MRI-assessments; 11. Risk of non-compliance.

Design outcomes

Primary

Measure	Time frame
Magnetic resonance (MR) assessment of the carotid artery wall, MR-measured hepatic, intra-abdominal and peripheral subcutaneous fat stores.	—

Secondary

Measure	Time frame
1. Assessment of the changes in selected inflammatory and metabolic parameters amongst which changes in insulin resistance & iNOS; 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; 3. The effect of Rosiglitazone on CEPs after one year of treatment in subjects with high cardiovascular risk without diabetes mellitus; 4. Optimalisation of MR assessment of (complex) atherosclerotic plaques & other cardiovascular risk markers.	—

Measure

Time frame

1. Assessment of the changes in selected inflammatory and metabolic parameters amongst which changes in insulin resistance & iNOS; 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; 3. The effect of Rosiglitazone on CEPs after one year of treatment in subjects with high cardiovascular risk without diabetes mellitus; 4. Optimalisation of MR assessment of (complex) atherosclerotic plaques & other cardiovascular risk markers.

—

Contacts

Public ContactR. Alizadeh Dehnavi

Leiden University Medical Center (LUMC), P.O. Box 9600

R.Alizadehdehnavi@lumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)