Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Regulation of Lipoprotein Transport in Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 10, 2009
First Posted Date  ICMJE February 11, 2009
Last Update Posted Date February 11, 2009
Study Start Date  ICMJE April 2003
Actual 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 ]
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Lipid Disorders
  • Cardiovascular Disease
Intervention  ICMJE
  • Drug: GW501516
    2.5mg/day
  • Drug: placebo pill
Study Arms  ICMJE
  • 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. doi: 10.1210/jc.2011-1131. 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
Actual Enrollment  ICMJE
 (submitted: February 10, 2009)
13
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00841217
Other Study ID Numbers  ICMJE UWA_PHR022009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account 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