No registrations found.
ID
Source
Brief title
Health condition
Metabolic Syndrome
Sponsors and support
Intervention
Outcome measures
Primary outcome
Magnetic resonance (MR) assessment of the carotid artery wall, MR-measured hepatic, intra-abdominal and peripheral subcutaneous fat stores.
Secondary outcome
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.
Background summary
To study the effects of rosiglitazone on the prevention of progression of atherosclerosis, and on selected inflammatory, metabolic and anthropometric parameters in high-risk patients with visceral obesity and the metabolic syndrome, without DM2 and Cardiovascular disease.
Study objective
The metabolic syndrome and its visceral adiposity may well be beneficially influenced by PPAR-ã agonist, by redistributing fat mass from central to peripheral stores and improving insulin resistance. The inflammatory atherosclerotic response, as monitored by CRP, may also directly be beneficially influenced by PPAR-ã agonists in human subjects. In addition, we hypothesize that thiazolidinediones will beneficially influence IMT in subjects with the metabolic syndrome as defined by the inclusion criteria.
Study design
N/A
Intervention
1. Lifestyle intervention;
2. Rosiglitazone 8 mg (4 mg bd) versus placebo.
P.O. Box 9600
R. Alizadeh Dehnavi
Albinusdreef 2
Leiden 2300 RC
The Netherlands
R.Alizadehdehnavi@lumc.nl
P.O. Box 9600
R. Alizadeh Dehnavi
Albinusdreef 2
Leiden 2300 RC
The Netherlands
R.Alizadehdehnavi@lumc.nl
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 <55y; female<60y);
5. CRP > 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 (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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL269 |
| NTR-old | NTR307 |
| Other | : P04.232 |
| ISRCTN | ISRCTN54951661 |