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Regulation of Lipoprotein Transport in Metabolic Syndrome

Primary Purpose

Obesity, Lipid Disorders, Cardiovascular Disease

Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
GW501516
placebo pill
Sponsored by
The University of Western Australia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Drug treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • University of Western Australia

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

placebo group

GW501516, 2.5mg

Outcomes

Primary Outcome Measures

ApoB transport rate

Secondary Outcome Measures

ApoA and C-III transport rate

Full Information

First Posted
February 10, 2009
Last Updated
February 10, 2009
Sponsor
The University of Western Australia
Collaborators
National Heart Foundation, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT00841217
Brief Title
Regulation of Lipoprotein Transport in Metabolic Syndrome
Official Title
Effect of PPAR-Delta Agonist on Lipoprotein Kinetics in Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The University of Western Australia
Collaborators
National Heart Foundation, Australia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Lipid Disorders, Cardiovascular Disease
Keywords
Drug treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
placebo group
Arm Title
2
Arm Type
Active Comparator
Arm Description
GW501516, 2.5mg
Intervention Type
Drug
Intervention Name(s)
GW501516
Intervention Description
2.5mg/day
Intervention Type
Drug
Intervention Name(s)
placebo pill
Primary Outcome Measure Information:
Title
ApoB transport rate
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
ApoA and C-III transport rate
Time Frame
5 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Western Australia
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
21816786
Citation
Ooi EM, Watts GF, Sprecher DL, Chan DC, Barrett PH. Mechanism of action of a peroxisome proliferator-activated receptor (PPAR)-delta agonist on lipoprotein metabolism in dyslipidemic subjects with central obesity. J Clin Endocrinol Metab. 2011 Oct;96(10):E1568-76. doi: 10.1210/jc.2011-1131. Epub 2011 Aug 3.
Results Reference
derived

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Regulation of Lipoprotein Transport in Metabolic Syndrome

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