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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02368379 |
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Date of registration:
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05/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome
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Scientific title:
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Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome |
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Date of first enrolment:
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March 2014 |
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Target sample size:
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23 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02368379 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Individuals with Prader Willi Syndrome ages 2 years and older
Exclusion Criteria:
- 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).
Age minimum:
2 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Prader Willi Syndrome
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Adrenal Insufficiency
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Intervention(s)
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Other: Low dose (1 mcg) ACTH stimulation test
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Other: Overnight metyrapone test
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Primary Outcome(s)
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Presence of central adrenal insufficiency using low dose (1 mcg) ACTH stimulation test
[Time Frame: 40 minutes]
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Prescence of central adrenal insufficiency using overnight metyrapone test
[Time Frame: 8 hours]
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Secondary Outcome(s)
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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