Despite therapeutic advances, cardio metabolic disease still remains an important cause of death worldwide. The endocannabinoid system seems to be a new target for multiple risk factor management as it modulates food intake and adipogenesis. Selectively blocking the cannabinoid CB1 receptor with rimonabant has been shown to improve waist circumference, HDL-cholesterol, triglycerides and insulin resistance.
Conditions
Interventions
Trade Name: Accomplia
Product Name: rimonabant
Product Code: 168273-06-1
Pharmaceutical Form: Tablet
CAS Number: 168273061
Pharmaceutical form of the placebo: Coated tablet
Route of administration of
Sponsors
Maastricht University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: we aim to include males and females 18 – 70 years of age who have a waist circumference >88 cm in women or >102 cm in men and diabetes mellitus type 2 or an impaired fasting blood glucose > 6.1 mmol/l in venous plasma. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the (cost)-effectiveness of reimbursing rimonabant plus lifestyle counselling (combination of dietary and exercise advise) on the use of rimonabant. ;Secondary Objective: Secondary, we will assess the safety and effectiveness of rimonabant when used in daily practice.;Primary end point(s): Primary outcomes will be measured after 4, 6 and 12 months, and include waist circumference, plasma glucose, HbA1C and the use of rimonabant. Secondary outcomes will be measured during the visits and at follow-up including lipid profile, body weight, blood pressure, smoking, QALYs and costs. | — |
Countries
Netherlands
Outcome results
None listed