Regulation of Lipoprotein Transport in Metabolic Syndrome

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

Tracking Information

• First Submitted Date: February 10, 2009
• First Posted Date: February 11, 2009
• Last Update Posted Date: February 11, 2009
• Study Start Date: April 2003
• Actual Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 10, 2009): ApoB transport rate [ Time Frame: 5 weeks ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: February 10, 2009): ApoA and C-III transport rate [ Time Frame: 5 weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Regulation of Lipoprotein Transport in Metabolic Syndrome
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Obesity
• Lipid Disorders
• Cardiovascular Disease

Intervention

• Drug: GW501516
  2.5mg/day
• Drug: placebo pill

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 10, 2009): 13
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2008
• Actual Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT00841217
• Other Study ID Numbers: UWA_PHR022009
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Prof P Hugh R Barrett, University of Western Australia
• Original Responsible Party: Same as current
• Current Study Sponsor: The University of Western Australia
• Original Study Sponsor: Same as current
• Collaborators: National Heart Foundation, Australia
• Investigators: Not Provided
• PRS Account: The University of Western Australia
• Verification Date: February 2009