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

Tracking Information
First Received Date ^ICMJE	February 10, 2009
Last Updated Date	February 10, 2009
Start Date ^ICMJE	April 2003
Primary Completion Date	August 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 10, 2009)	ApoB transport rate [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: February 10, 2009)	ApoA and C-III transport rate [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Regulation of Lipoprotein Transport in Metabolic Syndrome
Official Title ^ICMJE	Effect of PPAR-Delta Agonist on Lipoprotein Kinetics in Metabolic Syndrome
Brief Summary	The purpose of this study is to determine whether PPAR-delta agonist (GW5015156)had favorable effect on lipoprotein metabolism.
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 ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Obesity Lipid Disorders Cardiovascular Disease
Intervention ^ICMJE	Drug: GW501516 2.5mg/day Drug: placebo pill
Study Arm (s)	Placebo Comparator: 1 placebo group Intervention: Drug: placebo pill Active Comparator: 2 GW501516, 2.5mg Intervention: Drug: GW501516
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	13
Completion Date	December 2008
Primary Completion Date	August 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Australia

Administrative Information
NCT Number ^ICMJE	NCT00841217
Other Study ID Numbers ^ICMJE	UWA_PHR022009
Has Data Monitoring Committee	No
Responsible Party	Prof P Hugh R Barrett, University of Western Australia
Study Sponsor ^ICMJE	The University of Western Australia
Collaborators ^ICMJE	National Heart Foundation, Australia
Investigators ^ICMJE	Not Provided
Information Provided By	The University of Western Australia
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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