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
| ISRCTN | ISRCTN54951661 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54951661 |
| Secondary identifying numbers | P04.232; NTR307 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 05/04/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr R. Alizadeh Dehnavi
Scientific
Scientific
Leiden University Medical Centre (LUMC)
P.O. Box 9600
Leiden
2300 RC
Netherlands
| R.Alizadehdehnavi@lumc.nl |
Study information
| Study design | Randomised double blind placebo controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | RUBENS |
| Study hypothesis | The metabolic syndrome and its visceral adiposity may well be beneficially influenced by peroxisome proliferator-activated receptor (PPAR)-alpha agonist, by redistributing fat mass from central to peripheral stores and improving insulin resistance. The inflammatory atherosclerotic response, as monitored by C-reactive protein (CRP), may also directly be beneficially influenced by PPAR-alpha agonists in human subjects. In addition, we hypothesise that thiazolidinediones will beneficially influence intima-media thickness (IMT) in subjects with the metabolic syndrome as defined by the inclusion criteria. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Condition | Metabolic syndrome, atherosclerosis |
| Intervention | 1. Lifestyle intervention 2. Rosiglitazone 8 mg (4 mg twice daily [bd]) versus placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Rosiglitazone |
| Primary outcome measure | 1. Magnetic resonance (MR) assessment of the carotid artery wall 2. MR-measured hepatic, intra-abdominal and peripheral subcutaneous fat stores |
| Secondary outcome measures | 1. Assessment of the changes in selected inflammatory and metabolic parameters amongst which changes in insulin resistance and inducible nitric oxide synthase (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 and other cardiovascular risk markers |
| Overall study start date | 26/09/2005 |
| Overall study end date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 116 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 26/09/2005 |
| Recruitment end date | 01/04/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (Netherlands)
University/education
University/education
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/ |
|---|---|
"ROR" |
https://ror.org/027bh9e22 |
Funders
Funder type
Industry
GlaxoSmithKline (Netherlands)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- GlaxoSmithKline plc., GSK plc., GSK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/10/2011 | Yes | No |
