Regulation of Lipoprotein Transport in Metabolic Syndrome

Phase 4

Completed

• Conditions: Obesity; Lipid Disorders; Cardiovascular Disease
• Interventions: Drug: placebo pill; Drug: GW501516

• Registration Number: NCT00841217
• Lead Sponsor: The University of Western Australia

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 Timeline

• Study Start: 2003-04
• Primary Completion: 2005-08
• Study Completion: 2008-12
• Status Verified: 2009-02
• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Last Update Submitted: 2009-02-10
• Study First Posted: 2009-02-11
• Last Update Posted: 2009-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	placebo pill	placebo group
2	GW501516	GW501516, 2.5mg

Primary Outcome Measures

Name	Time	Method
ApoB transport rate	5 weeks

Secondary Outcome Measures

Name	Time	Method
ApoA and C-III transport rate	5 weeks

Trial Locations

Locations (1)

University of Western Australia; 🇦🇺 Perth, Western Australia, Australia