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VIsceral Fat Reduction Assessed by CT-scan On RImonabAnt

NCT00299325 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2016-06-06

No results posted yet for this study

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).

Conditions

  • Metabolic Syndrome

Interventions

DRUG

Rimonabant

Tablet, oral administration

DRUG

Placebo (for Rimonabant)

Tablet, oral administration

OTHER

Mild hypocaloric diet

Calculated by the dietitian based on the estimated basal metabolism rate and the physical activity

Sponsors & Collaborators

Principal Investigators

  • Valérie Pilorget, MD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States
  • Canada
  • Denmark
  • Finland
  • France
  • Italy
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00299325 on ClinicalTrials.gov