Pharmacological Regulation of Fat Transport in Metabolic Syndrome
Information source: The University of Western Australia
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity; Lipid Disorders; Hypertriglyceridemia; Cardiovascular Disease
Intervention: Atorvastatin and fenofibrate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: The University of Western Australia Official(s) and/or principal investigator(s):
Dick C Chan, PhD, Principal Investigator, Affiliation: University of Western Australia
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.
Clinical Details
Official title: Regulation of Lipoprotein Kinetics by Atorvastatin and Fenofibrate With the Metabolic Syndrome
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: VLDL-apoC-III transport rate
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.
Eligibility
Minimum age: 25 Years.
Maximum age: 70 Years.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: June 2001
Ending date: December 2007
Last updated: February 29, 2008
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