Prader Willi SyndromeNCT02368379
Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome
A study testing Low dose (1 mcg) ACTH stimulation test and Overnight metyrapone test in people with Prader Willi Syndrome and Adrenal Insufficiency, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine presence of central adrenal insufficiency in children with Prader Willi Syndrome using low dose (1 mcg) ACTH stimulation test compared to results of overnight metyrapone test. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prader Willi Syndrome, Adrenal Insufficiency
- What is being tested?
- Low dose (1 mcg) ACTH stimulation test and Overnight metyrapone test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Aug 2016
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Individuals with Prader Willi Syndrome ages 2 years and older
Who cannot join
- Individuals who are ill at the time of study
- Individuals who are pregnant at the time of study
- Individuals who it is deemed unsafe to stop taking medications known to affect the results of they study (hydrocortisone, phenytoin, estrogen, acetaminophen, oral anti-diabetic agents).
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
The purpose of this study is to determine presence of central adrenal insufficiency in children with Prader Willi Syndrome using low dose (1 mcg) ACTH stimulation test compared to results of overnight metyrapone test.
- Conditions
- Prader Willi Syndrome, Adrenal Insufficiency
- Being tested
- Low dose (1 mcg) ACTH stimulation test, Overnight metyrapone test
- Keywords
- Metyrapone, ACTH stimulation test
- Medical subject headings
- Prader-Willi Syndrome, Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose (1 mcg) ACTH stimulation testOther
Subjects will have baseline cortisol and ACTH drawn followed by administration of 1 mcg/m2 (max 1 mcg) of cortrosyn. Blood will be drawn at 20 and 40 minutes post cortrosyn for peak cortisol assessment of central adrenal insufficiency.
Overnight metyrapone testOther
Subjects will receive metyrapone 30 mg/kg (max 3 grams) by mouth at midnight. Blood will be drawn at 0800 AM the following morning for ACTH, cortisol and 11 deoxycortisol for assessment of central adrenal insufficiency.
| Study group | Role | What they receive |
|---|---|---|
| Assessment of Central Adrenal Insufficiency | Other | Patients will undergo low dose ACTH stimulation test followed by overnight metyrapone test to assess for central adrenal insufficiency. Receives: Other: Low dose (1 mcg) ACTH stimulation test; Other: Overnight metyrapone test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of central adrenal insufficiency using low dose (1 mcg) ACTH stimulation test
Measured: 40 minutes
Prescence of central adrenal insufficiency using overnight metyrapone test
Measured: 8 hours
Secondary outcomes (1)
Determine peak cortisol value on low dose (1 mcg) ACTH stimulation test that can accurately predict central adrenal insufficiency based on overnight metyrapone test with good sensitivity and specificity.
Measured: 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startMar 2014
- Primary completionAug 2016
- Study completionAug 2016
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.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manmohan Kamboj, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368379
- Sponsor's protocol ID
- 293113
- Status last verified
- Jan 2018
- First submitted
- 5 Feb 2015
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT02368379
- Acronym / sponsor ID
- 293113
- Conditions
- Prader Willi Syndrome, Adrenal Insufficiency
- Keywords
- Metyrapone, ACTH stimulation test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 23 Feb 2015 (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 presence of central adrenal insufficiency in children with Prader Willi Syndrome using low dose (1 mcg) ACTH stimulation test compared to results of overnight metyrapone test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment of Central Adrenal Insufficiency | Other | Other: Low dose (1 mcg) ACTH stimulation test, Other: Overnight metyrapone testPatients will undergo low dose ACTH stimulation test followed by overnight metyrapone test to assess for central adrenal insufficiency. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with Prader Willi Syndrome ages 2 years and older
Key exclusion criteria (3 listed)
- Individuals who are ill at the time of study
- Individuals who are pregnant at the time of study
- Individuals who it is deemed unsafe to stop taking medications known to affect the results of they study (hydrocortisone, phenytoin, estrogen, acetaminophen, oral anti-diabetic agents).
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 |
|---|---|---|
| Low dose (1 mcg) ACTH stimulation testSubjects will have baseline cortisol and ACTH drawn followed by administration of 1 mcg/m2 (max 1 mcg) of cortrosyn. Blood will be drawn at 20 and 40 minutes post cortrosyn for peak cortisol assessment of central adrenal insufficiency. | Other | Assessment of Central Adrenal Insufficiency |
| Overnight metyrapone testSubjects will receive metyrapone 30 mg/kg (max 3 grams) by mouth at midnight. Blood will be drawn at 0800 AM the following morning for ACTH, cortisol and 11 deoxycortisol for assessment of central adrenal insufficiency. | Other | Assessment of Central Adrenal Insufficiency |
Primary outcome
Presence of central adrenal insufficiency using low dose (1 mcg) ACTH stimulation test
Time frame: 40 minutes
Prescence of central adrenal insufficiency using overnight metyrapone test
Time frame: 8 hours
1 secondary outcome
Determine peak cortisol value on low dose (1 mcg) ACTH stimulation test that can accurately predict central adrenal insufficiency based on overnight metyrapone test with good sensitivity and specificity.
Time frame: 0
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 29 Jan 2018.
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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 study testing Low dose (1 mcg) ACTH stimulation test and Overnight metyrapone test in people with Prader Willi Syndrome and Adrenal Insufficiency, run by Nationwide Children's Hospital at 1 site in United States.
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 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 29 Jan 2018. 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 United States. 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?
Presence of central adrenal insufficiency using low dose (1 mcg) ACTH stimulation test (time frame: 40 minutes). The study lists 2 primary outcomes in all. 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 29 Jan 2018.