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…
ID
Bron
Verkorte titel
Aandoening
Metabolic Syndrome
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Magnetic resonance (MR) assessment of the carotid artery wall, MR-measured hepatic, intra-abdominal and peripheral subcutaneous fat stores.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
1. Lifestyle intervention;
2. Rosiglitazone 8 mg (4 mg bd) versus placebo.
Publiek
P.O. Box 9600
R. Alizadeh Dehnavi
Albinusdreef 2
Leiden 2300 RC
The Netherlands
R.Alizadehdehnavi@lumc.nl
Wetenschappelijk
P.O. Box 9600
R. Alizadeh Dehnavi
Albinusdreef 2
Leiden 2300 RC
The Netherlands
R.Alizadehdehnavi@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL269 |
| NTR-old | NTR307 |
| Ander register | : P04.232 |
| ISRCTN | ISRCTN54951661 |