Regulation of Lipoprotein Transport in Metabolic Syndrome

The University of Western Australia

Status and phase: Completed; Phase 4

Conditions: Obesity; Lipid Disorders; Cardiovascular Disease

Treatments: Drug: placebo pill; Drug: GW501516

Study type: Interventional

Funder types: Other

Identifiers

NCT00841217

UWA_PHR022009

Details and patient eligibility

About

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

Full 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.

Enrollment: 13 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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13 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

placebo group

Treatment:

Drug: placebo pill

2

Active Comparator group

Description:

GW501516, 2.5mg

Treatment:

Drug: GW501516