VIsceral Fat Reduction Assessed by CT-scan On RImonabAnt

Phase 3

Completed

Interventions: Drug: Rimonabant
Drug: Placebo (for Rimonabant)
Other: Mild hypocaloric diet

Brief Summary: 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).

Detailed Description: The total duration per patient will be approximately 15 months including a 12-month double-blind treatment period.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Rimonabant	Rimonabant	Rimonabant 20 mg once daily with mild hypocaloric diet
Rimonabant	Mild hypocaloric diet	Rimonabant 20 mg once daily with mild hypocaloric diet
Placebo	Placebo (for Rimonabant)	Placebo (for Rimonabant) once daily with mild hypocaloric diet
Placebo	Mild hypocaloric diet	Placebo (for Rimonabant) once daily with mild hypocaloric diet

Primary Outcome Measures

Name	Time	Method
Relative change in visceral fat area assessed by CT scan	From baseline to Month 12

Secondary Outcome Measures

Name	Time	Method
Change in anthropometric measures	From baseline to Month 12
Change in glucose control parameters	From baseline to Month 12
Change in adipokines, inflammatory and hemostatic markers	From baseline to Month 12
Absolute change in visceral fat area assessed by CT scan	From baseline to Month 12
Change in Liver fat content measured using CT scan	From baseline to Month 12
Change in specific lipid parameters	From baseline to Month 12
Percentages of patients with a metabolic syndrome	At 12 months