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Rimonabant · VICTORIA

VIsceral Fat Reduction Assessed by CT-scan On RImonabAnt

Ensayo de Sanofi en Metabolic Syndrome (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

254

previstos

Centros

9

Fin del objetivo primario

jul 2008

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en feb 2006.

Qué mide

Relative change in visceral fat area assessed by CT scan (From baseline to Month 12) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary 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).

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Ficha completa en ClinicalTrials.gov (NCT00299325), actualizada en jun 2016.