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Trial record 4 of 4 for:    GW501516
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Regulation of Lipoprotein Transport in Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT00841217
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : February 11, 2009
Sponsor:
Collaborator:
National Heart Foundation, Australia
Information provided by:
The University of Western Australia

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

Condition or disease Intervention/treatment Phase
Obesity Lipid Disorders Cardiovascular Disease Drug: GW501516 Drug: placebo pill Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of PPAR-Delta Agonist on Lipoprotein Kinetics in Metabolic Syndrome
Study Start Date : April 2003
Actual Primary Completion Date : August 2005
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: GW 501516

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 1
placebo group
 Drug: placebo pill
Active Comparator: 2
GW501516, 2.5mg
 Drug: GW501516
2.5mg/day


Outcome Measures
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Primary Outcome Measures :
  1. ApoB transport rate [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  1. ApoA and C-III transport rate [ Time Frame: 5 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00841217


Locations
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Australia, Western Australia
University of Western Australia
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
The University of Western Australia
National Heart Foundation, Australia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof P Hugh R Barrett, University of Western Australia
ClinicalTrials.gov Identifier: NCT00841217    
Other Study ID Numbers: UWA_PHR022009
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: February 11, 2009
Last Verified: February 2009
Keywords provided by The University of Western Australia:
Drug treatment
Additional relevant MeSH terms:
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Cardiovascular Diseases
Metabolic Syndrome
Lipid Metabolism Disorders
Insulin Resistance
 Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases