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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.


- candidate number1503
- NTR NumberNTR307
- ISRCTNISRCTN54951661
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsP04.232 
- Public TitleA 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.
- Scientific TitleA 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.
- ACRONYMRUBENS
- hypothesisThe metabolic syndrome and its visceral adiposity may well be beneficially influenced by PPAR- 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- 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.
- Healt Condition(s) or Problem(s) studiedAtherosclerose, Metabolic syndrome
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 26-sep-2005
- planned closingdate1-apr-2007
- Target number of participants116
- Interventions1. Lifestyle intervention;
2. Rosiglitazone 8 mg (4 mg bd) versus placebo.
- Primary outcomeMagnetic resonance (MR) assessment of the carotid artery wall, MR-measured hepatic, intra-abdominal and peripheral subcutaneous fat stores.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES R. Alizadeh Dehnavi
- CONTACT for SCIENTIFIC QUERIES R. Alizadeh Dehnavi
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
GlaxoSmithKline
- PublicationsN/A
- Brief summaryTo 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.
- Main changes (audit trail)
- RECORD9-sep-2005 - 24-nov-2009


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