Condition category
Circulatory System
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
05/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr R. Alizadeh Dehnavi

ORCID ID

Contact details

Leiden University Medical Centre (LUMC)
P.O. Box 9600
Leiden
2300 RC
Netherlands
R.Alizadehdehnavi@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P04.232; NTR307

Study information

Scientific title

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

Received from the local medical ethics committee

Study design

Randomised double blind placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Metabolic syndrome, atherosclerosis

Intervention

1. Lifestyle intervention
2. Rosiglitazone 8 mg (4 mg twice daily [bd]) versus placebo

Intervention type

Drug

Phase

Not Applicable

Drug names

Rosiglitazone

Primary outcome measures

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 trial start date

26/09/2005

Overall trial end date

01/04/2007

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Male

Target number of participants

116

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

Trial participating centre

Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (Netherlands)

Sponsor details

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

University/education

Website

http://www.lumc.nl/

Funders

Funder type

Industry

Funder name

GlaxoSmithKline (Netherlands)

Alternative name(s)

GlaxoSmithKline Plc., GSK

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22035351

Publication citations

  1. Results

    Roes SD, Dehnavi RA, Westenberg JJ, Lamb HJ, Mertens BJ, Tamsma JT, de Roos A, Effect of lifestyle intervention plus rosiglitazone or placebo therapy on left ventricular mass assessed with cardiovascular magnetic resonance in the metabolic syndrome., J Cardiovasc Magn Reson, 2011, 13, 65, doi: 10.1186/1532-429X-13-65.

Additional files

Editorial Notes