Pharmacological Regulation of Fat Transport in Metabolic Syndrome

February 29, 2008 updated by: The University of Western Australia

Regulation of Lipoprotein Kinetics by Atorvastatin and Fenofibrate With the Metabolic Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: P
placebo group
Drug: Atorvastatin and fenofibrate
atorvastatin (40mg/day) fenofibrate (200mg/day)
Other Names:
  • Lipitor
  • Lofibra
Active Comparator: Feno
Fenofibrate
Drug: Atorvastatin and fenofibrate
atorvastatin (40mg/day) fenofibrate (200mg/day)
Other Names:
  • Lipitor
  • Lofibra
Active Comparator: ATV
Atorvastatin
Drug: Atorvastatin and fenofibrate
atorvastatin (40mg/day) fenofibrate (200mg/day)
Other Names:
  • Lipitor
  • Lofibra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VLDL-apoC-III transport rate
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Western Australia

Collaborators

National Heart Foundation, Australia

Investigators

  • Principal Investigator: Dick C Chan, PhD, The University of Western Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

December 1, 2002

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

February 20, 2008

First Submitted That Met QC Criteria

February 29, 2008

First Posted (Estimate)

March 11, 2008

Study Record Updates

Last Update Posted (Estimate)

March 11, 2008

Last Update Submitted That Met QC Criteria

February 29, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UWA_DC012008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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