Pharmacological Regulation of Fat Transport in Metabolic Syndrome

Phase 4

Completed

• Conditions: Lipid Disorders; Hypertriglyceridemia; Cardiovascular Disease; Obesity
• Interventions: Drug: Atorvastatin and fenofibrate

• Registration Number: NCT00632840
• Lead Sponsor: The University of Western Australia

Brief Summary

The purpose of this study is to determine whether atorvastatin and fenofibrate are effective in the treatment of lipid disorders in obese, insulin resistant subjects.

Detailed Description

Insulin resistance is a heterogeneous metabolic disorder of complex etiology. It underpins dyslipoproteinemia, a key feature of the metabolic syndrome (MetS) that independently predicts cardiovascular disease (CVD). Hypertriglyceridemia, the most consistent lipid disorder in subjects with obesity and type 2 diabetes mellitus, is chiefly a consequence of overproduction and delayed clearance of triglyceride-rich lipoproteins (TRLs). Although the precise mechanisms involved are incompletely understood, experimental and clinical evidence suggests that elevated apolipoprotein (apo) C-III may play a crucial role in the dysregulation of TRL metabolism. investigating the effects of these agents on VLDL-apoC-III kinetics. In this study, we aimed to examine the effect of two lipid-regulating agents, atorvastatin and fenofibrate on VLDL-apoC-III transport. We hypothesized that atorvastatin and fenofibrate would have similar effects on apoC-III transport by decreasing the production and increasing the catabolism of VLDL-apoC-III.

Study Timeline

• Study Start: 2001-06
• Primary Completion: 2002-12
• Study Completion: 2007-12
• Status Verified: 2008-02
• Study First Submitted: 2008-02-20
• Study First Submitted QC: 2008-02-29
• Last Update Submitted: 2008-02-29
• Study First Posted: 2008-03-11
• Last Update Posted: 2008-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

Inclusion Criteria

any three of the followings

• waist circumference >102cm
• triglycerides >1.7 mmol/L
• HDL-cholesterol <1.05 mmol/L
• blood glucose >6.1 mmol/L
• blood pressure >130/85mmHg

Exclusion Criteria

• plasma cholesterol >7mmo/L
• triglycerides >4.5mmo/L
• diabetes mellitus (defined by oral glucose tolerance test)
• CVD
• consumption of >30g alcohol/day
• use of agents affecting lipid metabolism
• APOE2/E2 genotype, macroproteinuria
• creatinaemia (>120umol/L)
• hypothyroidism
• abnormal liver and muscle enzymes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ATV	Atorvastatin and fenofibrate	Atorvastatin
P	Atorvastatin and fenofibrate	placebo group
Feno	Atorvastatin and fenofibrate	Fenofibrate

Primary Outcome Measures

Name	Time	Method
VLDL-apoC-III transport rate	5 weeks