Regulation of Lipoprotein Transport in Metabolic Syndrome

Obesity Clinical Trial

Official title:

Effect of PPAR-Delta Agonist on Lipoprotein Kinetics in Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841217
• Other study ID #: UWA_PHR022009
• Status: Completed
• Phase: Phase 4
• First received: February 10, 2009
• Last updated: February 10, 2009
• Start date: April 2003
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: The University of Western Australia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2008
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Lipid Disorders
• Lipid Metabolism Disorders
• Metabolic Syndrome X
• Obesity

Intervention

Drug:
• GW501516
2.5mg/day
• placebo pill

Locations

Country	Name	City	State
Australia	University of Western Australia	Perth	Western Australia

Sponsors (2)

Lead Sponsor	Collaborator
The University of Western Australia	National Heart Foundation, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ApoB transport rate		5 weeks	No
Secondary	ApoA and C-III transport rate		5 weeks	No