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| CArdiometabolic Risk reDuctIOn by Rimonabant: the Effectiveness in Daily practice and its USE |
| ISRCTN | ISRCTN63367873 |
| ClinicalTrials.gov identifier | |
| Public title | CArdiometabolic Risk reDuctIOn by Rimonabant: the Effectiveness in Daily practice and its USE |
| Scientific title | |
| Acronym | CARDIO-REDUSE |
| Serial number at source | N/A |
| Study hypothesis | In the RIO study programme, the efficacy of rimonabant was examined. The next step is to assess the use of rimonabant, its safety and effectiveness in daily practice. In daily practice people also have other diseases, may use other medication and may be less compliant to use rimonabant than in the studies performed in research centres. All these factors could influence the use and effect of rimonabant on cardiometabolic risk reduction and therefore need to be assessed. |
| Lay summary | |
| Ethics approval | Approved by the Medical Ethics Board Maastricht University Hospital/Maastricht University (AZM/UM) on the 30th August 2006 (ref: MEC 06-3-050). |
| Study design | Randomised, placebo controlled, parallel group, double blinded trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Patient at cardiometabolic risk |
| Participants - inclusion criteria |
We aim to include people who fulfil at least the following inclusion criteria:
1. Informed consent must be obtained in writing for all subjects at enrolment into the study 2. Male or female 18 to 75 years of age 3. Willingness and ability to comply with the study protocol (including the lifestyle counselling) 4. Waist circumference more than 88 cm in women and more than 102 cm in men 5. Diabetes mellitus type two or an impaired fasting blood glucose more than 6.1 mmol/l in venous plasma |
| Participants - exclusion criteria |
Participants are excluded from participation in the study if:
1. Pregnant or breast-feeding women, or women planning to become pregnant 2. Previous use of rimonabant 3. History of surgical procedures for weight loss (e.g., stomach stapling, bypass) 4. Morbid obese patients (Body Mass Index [BMI] more than 40 kg/m^2), history of bulimia or anorexia nervosa 5. Presence of any clinically significant endocrine disease 6. Severe renal dysfunction (creatinine clearance more than 30 ml/min) or nephrotic syndrome 7. Known chronic hepatitis or clinically significant hepatic disease 8. Significant haematology abnormalities (haemoglobin less than 100 g/L and/or neutrophils less than 1.5 G/L and/or platelets less than 100 G/L) 9. Cardiac status New York Heart Association (NYHA) III or IV or Electrocardiogram (ECG) within six months showing acute changes 10. Any current malignancy or any cancer with the past five years (except adequately treated basal cell skin cancer or cervical carcinoma in situ) 11. History of seizure disorder 12. Acute psychiatric disorders or prolonged use within the last three months of neuroleptics 13. History of severe depression that could be defined as depression which necessitated the patient to be hospitalised, or patients with two or more recurrent episodes of depression or a history of suicide attempt and/or prolonged use (more than one week) within the last three months use of antidepressants (including bupropion) 14. History of alcohol or other substance abuse, use of hashish or marijuana use 15. Use of any investigational treatment (drug or device) within 30 days prior to screening 16. Prolonged use (more than one week) within the last three months of systemic corticosteroids |
| Anticipated start date | 15/09/2006 |
| Anticipated end date | 01/04/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 600 |
| Interventions | Participants in the different study groups receive no medication, rimonabant or placebo plus three life style counselling sessions. |
| Primary outcome measure(s) | Main study parameters/endpoints: Primary outcomes will be measured after three, six, and 12 months, and include waist circumference, plasma glucose, HbA1C and the use of rimonabant. |
| Secondary outcome measure(s) | Secondary outcomes will be measured during the visits and at follow-up including lipid profile, body weight, blood pressure, smoking, Quality Adjusted Life Years (QALYs) and costs. |
| Sources of funding | This trial is initiated by the principal investigator C.P. van Schayck and in part financed by the Care and Public Health Research Institute and Sanofi-Aventis (The Netherlands). |
| Trial website | |
| Publications |
James PT, Rigby N, Leach R. The obesity epidemic, metabolic syndrome and future prevention strategies. Eur J Cardiovasc Prev Rehabil 2004;11:3-8.
Health council of the Netherlands. Obesity and Overweight. The Hague: Health council of the Netherlands, 2003:1-158. Zimmet P, Alberti KGMM, Shaw J. Globac and societal implications of the diabetic epidemic. Nature 2001;414(6865):782-787. Qureshi AI, Fareed M, Sure K, Kirmani JF, Divani AA. The relative impact of inadequate primary and secondary prevention on cardiovasculair mortality in the United States. Stroke 2004;35:2346-2350. Depres J-P, Golay A, Sjostrom L. Effects of rimonabant on metabolic risk factors in overweight patients with dyslipidemia. New England Journal of Medicine 2005;353(20):2121-2133. Van Gaal LF, Rissanen AM, Ziegler O, Rossner S. Effects of the cannabinoid-1 receptor blocker rimonabant on weight reduction and cardiovascular risk factors in overweight patients: 1-year experience from the RIO-Europe study. The Lancet 2005;365:1389-1397. Kaper J, Wagena EJ, Willemsen MC, Van Schayck CP. Reimbursement for smoking cessation treatment may double the abstinence rate: Results of a randomised trial. Addiction 2005;100:1012-1020. Banga JD, Man-Van Ginkel J, Sol-De Rijk BGM, Visseren FLJ, Westra TE. Handboek Vasculair risicomanagement door de nurse practitioner. Utrecht: UMC Utrecht, 2004. |
| Contact name | Dr J Kaper |
| Address |
University Maastricht (UM)
CAPHRI Research Institute P.O. Box 616 |
| City/town | Maastricht |
| Zip/Postcode | 6200 MD |
| Country | Netherlands |
| Tel | +31 (0)43 388 2420 |
| janneke.kaper@hag.unimaas.nl | |
| Sponsor | University Maastricht (UM) (The Netherlands) |
| Address |
c/o Prof. Dr. Van Schayck
Department General Practitioner Medicine P.O.Box 616 |
| City/town | Maastricht |
| Zip/Postcode | 6200 MD |
| Country | Netherlands |
| Tel | +31 (0)43 388 2314 |
| Fax | +31 (0)43 361 9344 |
| onno.vanschayck@hag.unimaas.nl | |
| Sponsor website: | http://www.unimaas.nl/ |
| Date applied | 28/12/2006 |
| Last edited | 05/01/2007 |
| Date ISRCTN assigned | 28/12/2006 |
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