Metabolic Syndrome Clinical Trial
Official title:
A Randomized, Double Blind, Two-arm Placebo Controlled, 12-Month Study of the Effects of Rimonabant 20mg Once Daily on the Amount and the Activity of Visceral Fat in Abdominally Obese Patients With Metabolic Syndrome.
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).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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