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Regulation of Lipoprotein Transport in Metabolic Syndrome

T

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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