CArdiometabolic Risk reDuctIOn by Rimonabant: the Effectiveness in Daily practice and its USE.
- Registration Number
- NL-OMON20796
- Lead Sponsor
- Maastricht University
- Brief Summary
James PT, Rigby N, Leach R. The obesity epidemic, metabolic syndrome and future prevention strategies. Eur J Cardiovasc Prev Rehabil 2004;11:3-8.<br> Health council of the Netherlands. Obesity and Overweight. The Hague: Health council of the Netherlands, 2003:1-158.<br> Zimmet P, Alberti KGMM, Shaw J. Globac and societal implications of the diabetic epidemic. Nature 2001;414(6865):782-787.<br> 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.<br> 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.<br> 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.<br> 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.<br> 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.<br>
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 600
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 enrollment into the study
Participants are excluded from participation in the study if:
1. Pregnant or breast-feeding women, or women planning to become pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main study parameters/endpoints: Primary outcomes will be measured after 3, 6, and 12 months, and include waist circumference, plasma glucose, HbA1C and the use of rimonabant.
- Secondary Outcome Measures
Name Time Method Secondary outcomes will be measured during the visits and at follow-up including lipid profile, body weight, blood pressure, smoking, QALYs and costs.<br>