Cardiovascular Disease, Lipid Disorders, Obesity
Conditions
Keywords
Drug treatment
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.
Interventions
DRUGGW501516
2.5mg/day
DRUGplacebo pill
Sponsors
National Heart Foundation, Australia
The University of Western Australia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ApoB transport rate | 5 weeks |
Secondary
| Measure | Time frame |
|---|---|
| ApoA and C-III transport rate | 5 weeks |
Countries
Australia
Outcome results
None listed