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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
  Purpose

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


Condition Intervention Phase
Obesity
Lipid Disorders
Cardiovascular Disease
 Drug: GW501516
Drug: placebo pill
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of PPAR-Delta Agonist on Lipoprotein Kinetics in Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Western Australia:

Primary Outcome Measures:
  • ApoB transport rate [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ApoA and C-III transport rate [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: April 2003
Study Completion Date: December 2008
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
placebo group
 Drug: placebo pill
Active Comparator: 2
GW501516, 2.5mg
 Drug: GW501516
2.5mg/day

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841217

Locations
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

No publications provided by The University of Western Australia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof P Hugh R Barrett, University of Western Australia
ClinicalTrials.gov Identifier: NCT00841217     History of Changes
Other Study ID Numbers: UWA_PHR022009
Study First Received: February 10, 2009
Last Updated: February 10, 2009
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by The University of Western Australia:
Drug treatment

Additional relevant MeSH terms:
Cardiovascular Diseases
Obesity
Lipid Metabolism Disorders
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Signs and Symptoms
Metabolic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 23, 2013