NCT00841217

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_4 obesity

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_4 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
Last Updated

February 11, 2009

Status Verified

February 1, 2009

Enrollment Period

2.3 years

First QC Date

February 10, 2009

Last Update Submit

February 10, 2009

Conditions

ObesityLipid DisordersCardiovascular Disease

Keywords

Drug treatment

Outcome Measures

Primary Outcomes (1)

  • ApoB transport rate

    5 weeks

Secondary Outcomes (1)

  • ApoA and C-III transport rate

    5 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

placebo group

Drug: placebo pill

2

ACTIVE COMPARATOR

GW501516, 2.5mg

Drug: GW501516

Interventions

GW501516DRUG

2.5mg/day

2
placebo pillDRUG
1

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Western Australia

Perth, Western Australia, 6000, Australia

Location

Related Publications (1)

  • 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.

    PMID: 21816786DERIVED

MeSH Terms

Conditions

ObesityLipid Metabolism DisordersCardiovascular Diseases

Interventions

GW 501516

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMetabolic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 11, 2009

Study Start

April 1, 2003

Primary Completion

August 1, 2005

Study Completion

December 1, 2008

Last Updated

February 11, 2009

Record last verified: 2009-02

Locations

AU(1)