Regulation of Lipoprotein Transport in Metabolic Syndrome

February 10, 2009 updated by: The University of Western Australia

Effect of PPAR-Delta Agonist on Lipoprotein Kinetics in Metabolic Syndrome

The purpose of this study is to determine whether PPAR-delta agonist (GW5015156)had favorable effect on lipoprotein metabolism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The metabolic syndrome (MetS) portends diabetes and cardiovascular disease (CVD). Dyslipoproteinaemia, reflected by elevated plasma triglyceride and reduced high-density lipoprotein (HDL) concentrations, is a cardinal feature of MetS that independently predicts CVD and is accordingly a therapeutic target for risk reduction. GW5015156 is a new PPAR-delta agonist that could be used to treat dyslipidemia in insulin resistance and obesity. However, the precise mechanisms of action of this agent on lipoprotein kinetics in MetS subjects have not yet fully been investigated. We therefore carried out a study to study the effect of GW5015156 on lipoprotein transport in subject with metabolic syndrome.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • University of Western Australia

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Any three of the following:

    • Waist circumference > 102 cm
    • Triglycerides > 150 mg/dL
    • HDL-cholesterol < 40 mg/dL
    • Blood glucose > 110 mhg/dL
    • Blood pressures > 130/85 mmHg

Exclusion Criteria:

  • Triglycerides > 500 mg/dL
  • Diabetes mellitus
  • CVD
  • Consumption of > 30 g alcohol/day
  • Use of agents affecting lipid metabolism
  • APOE2/E2 genotype
  • Creatinemia (> 120 umol/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: 1
placebo group
Drug: placebo pill
Active Comparator: 2
GW501516, 2.5mg
Drug: GW501516
2.5mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ApoB transport rate
Time Frame: 5 weeks
5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
ApoA and C-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

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

April 1, 2003

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

February 10, 2009

First Submitted That Met QC Criteria

February 10, 2009

First Posted (Estimate)

February 11, 2009

Study Record Updates

Last Update Posted (Estimate)

February 11, 2009

Last Update Submitted That Met QC Criteria

February 10, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UWA_PHR022009

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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