Regulation of Lipoprotein Transport in Metabolic Syndrome | NCT00841217

Studies
Regulation of Lipoprotein Transport in Metabolic Syndrome

NCT00841217

Sponsor

The University of Western Australia

Status

Completed

Last Update Posted

Feb 11, 2009Estimated

Enrollment

13Actual

Phase

Phase 4

Conditions

Obesity
Lipid Disorders
Cardiovascular Disease

Interventions

GW501516
placebo pill

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Aug 2005Actual

Completion Date

Dec 2008Actual

First Submitted Date

Feb 10, 2009

First Submission Date that Met QC Criteria

Feb 10, 2009

First Posted Date

Feb 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2009

Last Update Posted Date

Feb 11, 2009Estimated

Name	Class
National Heart Foundation, Australia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	placebo group	Drug: placebo pill
2	Active Comparator	GW501516, 2.5mg	Drug: GW501516

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GW501516	Drug	2.5mg/day	2
placebo pill

Measure	Description	Time Frame
ApoB transport rate		5 weeks

Measure	Description	Time Frame
ApoA and C-III transport rate		5 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Western Australia		Perth	Western Australia	6000	Australia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21816786	Derived	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.

ID	Term
D009765	Obesity
D052439	Lipid Metabolism Disorders
D002318	Cardiovascular Diseases

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases