Prader-Willi SyndromeNCT00551343
Gut Derived Hormones, Body Composition and Metabolism in Prader-Willi Syndrome
A study testing Exenatide in people with Prader-Willi Syndrome, run by Garvan Institute of Medical Research at 1 site in Australia.
Trial summary
The purpose of this study is to investigate the effects of a GLP-1 agonist on satiety hormones in patients with Prader-Willi Syndrome (genetic defect causing obesity). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Prader-Willi Syndrome
- What is being tested?
- Exenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2007to Sep 2008
- Phase
- Interventional
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- see below
Who cannot join
- Diabetes mellitus, acute infections
Trial locations and contacts
1 site in 1 country.
Australia1 site
Garvan Institute of Medical Research
Sydney, New South Wales, 2010
About this study
Official title: Contribution of a GLP-1 Agonist to Appetite Regulation, Metabolism and Body Composition in Subjects With Prader-Willi Syndrome.
The purpose of this study is to investigate the effects of a GLP-1 agonist on satiety hormones in patients with Prader-Willi Syndrome (genetic defect causing obesity).
Read the detailed description
Prader-Willi Syndrome (PWS) is the most frequent known genetic disorder of obesity. Hyperphagia is the main barrier to independent living in adults with PWS, and hitherto behavioural restraints and environmental modification are the only effective management measure. The emerging costs for professional care are immense. Thus, there is an urgent need for treatment which reduce appetite and food intake in this patient group. Agonists of the gut derived hormone GLP-1 which reduces food intake and causes weight loss due to slowed gastric emptying and through direct central effects. The aim of this pilot drug trial is to analyse the effect of a GLP-1 agonist on appetite regulating hormones, insulin secretion and energy expenditure before and after a meal.
- Conditions
- Prader-Willi Syndrome
- Being tested
- Exenatide
- Medical subject headings
- Prader-Willi Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
10ug Exenatide single s.c. injection
| Study group | Role | What they receive |
|---|---|---|
| PWS | Other | Not described Receives: Drug: Exenatide |
| Controls | Other | Not described Receives: Drug: Exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
satiety hormones
Measured: 1 day
Secondary outcomes (1)
appetite (visual analogue scale) insulin secretion
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prader-Willi SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Garvan Institute of Medical Research
- Sponsor type
- University, hospital or other
- Investigators
- Lesley V Campbell, Prof, Principal investigator, Garvan Institute of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551343
- Sponsor's protocol ID
- H07/045
- Other IDs
- X07-0178
- Status last verified
- Oct 2007
- First submitted
- 29 Oct 2007
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of a GLP-1 Agonist to Appetite Regulation, Metabolism and Body Composition in Subjects With Prader-Willi Syndrome.
- ClinicalTrials.gov ID
- NCT00551343
- Acronym / sponsor ID
- H07/045
- Conditions
- Prader-Willi Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Garvan Institute of Medical ResearchUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 30 Oct 2007 (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 investigate the effects of a GLP-1 agonist on satiety hormones in patients with Prader-Willi Syndrome (genetic defect causing obesity).
Detailed description
Prader-Willi Syndrome (PWS) is the most frequent known genetic disorder of obesity. Hyperphagia is the main barrier to independent living in adults with PWS, and hitherto behavioural restraints and environmental modification are the only effective management measure. The emerging costs for professional care are immense. Thus, there is an urgent need for treatment which reduce appetite and food intake in this patient group. Agonists of the gut derived hormone GLP-1 which reduces food intake and causes weight loss due to slowed gastric emptying and through direct central effects. The aim of this pilot drug trial is to analyse the effect of a GLP-1 agonist on appetite regulating hormones, insulin secretion and energy expenditure before and after a meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PWS | Other | Drug: Exenatide |
| Controls | Other | Drug: Exenatide |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- see below
Key exclusion criteria (1 listed)
- Diabetes mellitus, acute infections
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 |
|---|---|---|
| Exenatide10ug Exenatide single s.c. injection | Drug | Controls, PWS |
Primary outcome
satiety hormones
Time frame: 1 day
1 secondary outcome
appetite (visual analogue scale) insulin secretion
Time frame: 1 day
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 7 Jul 2020.
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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.
Lesley V Campbell, Prof principal investigator
Garvan Institute of Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exenatide in people with Prader-Willi Syndrome, run by Garvan Institute of Medical Research 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 1 inclusion and 1 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 7 Jul 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
satiety hormones (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2020.