The objective of the study is to evaluate the effect of Rimonabant 20mg in comparison to placebo, on HDL and VLDL lipoprotein kinetics, over a 12 months period. Primary objectives: * To assess effect of Rimonabant on HDL ApoA-I fractional catabolic rate (FCR). Secondary objectives: * To assess effect of Rimonabant on HDL ApoA-I production rate (PR) and on other lipoprotein kinetics. * To assess effect of Rimonabant on lipids, glycemic and inflammatory parameters * To assess effect of Rimonabant on body composition * To assess safety of Rimonabant
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
Undistinguishable placebo tablets
White film-coated, for oral administration containing 20 mg of active rimonabant
Sanofi-Aventis Administrative Office
North Ryde, Australia
Sanofi-Aventis Administrative Office
Helsinki, Finland
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Guildford, United Kingdom
The fractional catabolic rate (FCR) of HDL ApoA-I
Time frame: After 12 months of treatment.
Production Rate (PR) of HDL ApoA-I and A-II, (FCR) of HDL ApoA-II
Time frame: All across the study
PR and FCR of VLDL1 and VLDL2 Apo B, VLDL1 and VLDL2 TG, IDL Apo B and LDL Apo B
Time frame: All across the study
Variation in ApoA-I, ApoA-II, Lp-AI, Lp-AII, pre-beta-HDL HDL2a, HDL2b, HDL3a, HDL3b, HDL3c, Apo B, Apo C III, TG, LDL-C, HDL-C levels
Time frame: All across the study
Variation in Glucose, insulin, HbA1c, leptin, adiponectin
Time frame: All across the study
Variation in hs-CRP, TNF-alpha, CETP, PLTP and LCAT activities, lipoprotein and hepatic lipase activities in post-heparin plasma
Time frame: All across the study
Variation in whole body fat
Time frame: All across the study
Variation in abdominal sub-cutaneous and visceral fat
Time frame: All across the study
Variation in liver fat
Time frame: All across the study
Variation in blood pressure
Time frame: All across the study
Variation in body weight, waist circumference, waist/hip ratio
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From the beginning to the end of the study
CE/TG ratio in HDL
Time frame: All across the study
Adverse events
Time frame: From the beginning to the end of the study