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Regulation of Lipoprotein Transport in Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborator:
National Heart Foundation, Australia
Information provided by:
The University of Western Australia
ClinicalTrials.gov Identifier:
NCT00841217
First received: February 10, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

February 10, 2009
February 10, 2009
April 2003
August 2005   (final data collection date for primary outcome measure)
ApoB transport rate [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
ApoA and C-III transport rate [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Regulation of Lipoprotein Transport in Metabolic Syndrome
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Obesity
  • Lipid Disorders
  • Cardiovascular Disease
  • Drug: GW501516
    2.5mg/day
  • Drug: placebo pill
  • Placebo Comparator: 1
    placebo group
    Intervention: Drug: placebo pill
  • Active Comparator: 2
    GW501516, 2.5mg
    Intervention: Drug: GW501516
Ooi EM, Watts GF, Sprecher DL, Chan DC, Barrett PH. Mechanism of action of a peroxisome proliferator-activated receptor (PPAR)-delta agonist on lipoprotein metabolism in dyslipidemic subjects with central obesity. J Clin Endocrinol Metab. 2011 Oct;96(10):E1568-76. Epub 2011 Aug 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
December 2008
August 2005   (final data collection date for primary outcome measure)

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
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00841217
UWA_PHR022009
No
Prof P Hugh R Barrett, University of Western Australia
The University of Western Australia
National Heart Foundation, Australia
Not Provided
The University of Western Australia
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP