Prader-Willi SyndromeNCT00932932
Cortisol Activity in Patients With Prader-Willi Syndrome and Healthy Controls
An observational study of Prader-Willi Syndrome, run by Children's Mercy Hospital Kansas City.
Trial summary
The purpose of the study is to find out if people with Prader-Willi syndrome have a difference in the protein which changes inactive cortisone to the active stress hormone cortisol. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Prader-Willi Syndrome
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Aug 2010
- Phase
- Observational
- 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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Defined population
Who may be able to join
- Prader-Willi syndrome confirmed by molecular testing, ages 6 months to adult
- Controls: Age-matched, sex-matched, developmentally normal, BMI-controlled healthy or obese subjects
Who cannot join
- PWS subjects without molecular confirmation of the diagnosis
- Subjects receiving glucocorticoid treatment within 3 months of evaluation
- Subjects receiving growth hormone within one year prior to analysis
About this study
Official title: 11 Beta Hydroxysteroid Dehydrogenase 1 (11-beta HSD 1) Activity in Patients With Prader-Willi Syndrome and in Healthy Controls
The purpose of the study is to find out if people with Prader-Willi syndrome have a difference in the protein which changes inactive cortisone to the active stress hormone cortisol.
- Conditions
- Prader-Willi Syndrome
- 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.
| Study group | Role | What they receive |
|---|---|---|
| PWS not receiving Growth Hormone | Not described | |
| Control subjects healthy or obese | Not described | |
| PWS subjects starting Growth Hormone | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startFeb 2009
- Study completionAug 2010
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Investigators
- Wayne Moore, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932932
- Sponsor's protocol ID
- 09 01-014
- Status last verified
- Jun 2011
- First submitted
- 2 Jul 2009
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 11 Beta Hydroxysteroid Dehydrogenase 1 (11-beta HSD 1) Activity in Patients With Prader-Willi Syndrome and in Healthy Controls
- ClinicalTrials.gov ID
- NCT00932932
- Acronym / sponsor ID
- 09 01-014
- Conditions
- Prader-Willi Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Feb 2009
- Study completion
- Aug 2010 (actual)
- First posted
- 7 Jul 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 the study is to find out if people with Prader-Willi syndrome have a difference in the protein which changes inactive cortisone to the active stress hormone cortisol.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PWS not receiving Growth Hormone | – | – |
| Control subjects healthy or obese | – | – |
| PWS subjects starting Growth Hormone | – | – |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Defined population
Key inclusion criteria (2 listed)
- Prader-Willi syndrome confirmed by molecular testing, ages 6 months to adult
- Controls: Age-matched, sex-matched, developmentally normal, BMI-controlled healthy or obese subjects
Key exclusion criteria (3 listed)
- PWS subjects without molecular confirmation of the diagnosis
- Subjects receiving glucocorticoid treatment within 3 months of evaluation
- Subjects receiving growth hormone within one year prior to analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 27 Jun 2011.
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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.
Wayne Moore, MD principal investigator
Children's Mercy Hospital Kansas City
Questions about this trial
What is this clinical trial studying?
An observational study of Prader-Willi Syndrome, run by Children's Mercy Hospital Kansas City.
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 2 inclusion and 3 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 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
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 27 Jun 2011.