VIsceral Fat Reduction Assessed by CT-scan On RImonabAnt
Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
Participant gender:
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).