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Completed

NCT Number: NCT00841217

Regulation of Lipoprotein Transport in Metabolic Syndrome

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

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Key information

Conditions

Obesity Body Weight Cardiovascular Disease Cardiovascular Diseases Lipid Disorders Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

University of Western Australia

Perth, Western Australia, 6000, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GW501516

Drug

2.5mg/day

Placebo pill

Drug

Primary outcomes

  1. ApoB transport rate

    Time frame: 5 weeks

Secondary outcomes

  1. ApoA and C-III transport rate

    Time frame: 5 weeks

Sponsors and collaborators

Lead sponsor

The University of Western Australia

Other

Collaborators

  • National Heart Foundation, Australia

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2005
Study completion
2008
First posted
Feb 11, 2009
Registry last updated
Feb 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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