ObesityPhase 4NCT00841217
Regulation of Lipoprotein Transport in Metabolic Syndrome
A Phase 4 study testing GW501516 in people with Obesity and Lipid Disorders, run by The University of Western Australia at 1 site in Australia.
Trial summary
The purpose of this study is to determine whether PPAR-delta agonist (GW5015156)had favorable effect on lipoprotein metabolism. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Obesity, Lipid Disorders, Cardiovascular Disease
- What is being tested?
- GW501516
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2003to Dec 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Triglycerides > 500 mg/dL
- Diabetes mellitus
- CVD
- Consumption of > 30 g alcohol/day
- Use of agents affecting lipid metabolism
- APOE2/E2 genotype
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- Creatinemia (> 120 umol/L)
- Hypothyroidism
- Abnormal liver and muscle enzymes
Trial locations and contacts
1 site in 1 country.
Australia1 site
University of Western Australia
Perth, Western Australia, 6000
About this study
Official title: Effect of PPAR-Delta Agonist on Lipoprotein Kinetics in Metabolic Syndrome
The purpose of this study is to determine whether PPAR-delta agonist (GW5015156)had favorable effect on lipoprotein metabolism.
Read the 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.
- Conditions
- Obesity, Lipid Disorders, Cardiovascular Disease
- Being tested
- GW501516, placebo pill
- Keywords
- Drug treatment
- Medical subject headings
- Obesity, Lipid Metabolism Disorders, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW501516Drug
2.5mg/day
placebo pillDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | placebo group Receives: Drug: placebo pill |
| 2 | Active comparator | GW501516, 2.5mg Receives: Drug: GW501516 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ApoB transport rate
Measured: 5 weeks
Secondary outcomes (1)
ApoA and C-III transport rate
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startApr 2003
- Primary completionAug 2005
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Western Australia
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart Foundation, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841217
- Sponsor's protocol ID
- UWA_PHR022009
- Status last verified
- Feb 2009
- First submitted
- 10 Feb 2009
- Last updated
- 11 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21816786
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PPAR-Delta Agonist on Lipoprotein Kinetics in Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00841217
- Acronym / sponsor ID
- UWA_PHR022009
- Conditions
- Obesity, Lipid Disorders, Cardiovascular Disease
- Keywords
- Drug treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- The University of Western AustraliaUniversity, hospital or other
- Collaborators
- National Heart Foundation, Australia
- Study start
- Apr 2003
- Primary completion
- Aug 2005 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 11 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placebo pillplacebo group |
| 2 | Active comparator | Drug: GW501516GW501516, 2.5mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Any three of the following:
Key exclusion criteria (9 listed)
- Triglycerides > 500 mg/dL
- Diabetes mellitus
- CVD
- Consumption of > 30 g alcohol/day
- Use of agents affecting lipid metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GW5015162.5mg/day | Drug | 2 |
| placebo pill | Drug | 1 |
Primary outcome
ApoB transport rate
Time frame: 5 weeks
1 secondary outcome
ApoA and C-III transport rate
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2009.
- Derived from this study: PubMed 21816786Ooi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GW501516 in people with Obesity and Lipid Disorders, run by The University of Western Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ApoB transport rate (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00841217, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2009.