Primary objective: To assess the effect of rimonabant on visceral fat area over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with metabolic syndrome Secondary objectives: * To assess the effect of rimonabant over a period of 12 months on: * Liver fat content using CT scan (Computed Tomography scan) * Anthropometric measures (weight, waist circumference, body composition using Dual Energy X-ray Absorptiometry (DEXA)) * Lipid, lipoprotein profile * Glycemia, insulinemia and HbA1c * Adipokines, inflammatory and hemostatic markers * To evaluate the percentage of patients with metabolic syndrome at 12 months * To evaluate the safety and tolerability of rimonabant in these patients In four selected US sites the effect of rimonabant at 12 months will be also assessed on: * Basal lipolysis and insulin suppressed lipolysis (euglycemic hyperinsulinemic clamp). * Resting metabolic rate and substrate oxidation at rest using indirect calorimetry. * Adipose tissue histology and expression of genes involved in glucose and lipid metabolism (superficial adipose tissue biopsy).
The total duration per patient will be approximately 15 months including a 12-month double-blind treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
254
Tablet, oral administration
Tablet, oral administration
Calculated by the dietitian based on the estimated basal metabolism rate and the physical activity
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Laval, Canada
Sanofi-Aventis Administrative Office
Hoersholm, Denmark
Sanofi-Aventis Administrative Office
Helsinki, Finland
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Milan, Italy
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sanofi-Aventis Administrative Office
Stockholm, Sweden
Sanofi-Aventis Administrative Office
Guildford, United Kingdom
Relative change in visceral fat area assessed by CT scan
Time frame: From baseline to Month 12
Absolute change in visceral fat area assessed by CT scan
Time frame: From baseline to Month 12
Change in Liver fat content measured using CT scan
Time frame: From baseline to Month 12
Change in anthropometric measures
Time frame: From baseline to Month 12
Change in specific lipid parameters
Time frame: From baseline to Month 12
Change in glucose control parameters
Time frame: From baseline to Month 12
Change in adipokines, inflammatory and hemostatic markers
Time frame: From baseline to Month 12
Percentages of patients with a metabolic syndrome
Time frame: At 12 months
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