Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome
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|ClinicalTrials.gov Identifier: NCT02368379|
Recruitment Status : Completed
First Posted : February 23, 2015
Last Update Posted : January 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prader Willi Syndrome Adrenal Insufficiency||Other: Low dose (1 mcg) ACTH stimulation test Other: Overnight metyrapone test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Assessment of Central Adrenal Insufficiency
Patients will undergo low dose ACTH stimulation test followed by overnight metyrapone test to assess for central adrenal insufficiency.
Other: Low dose (1 mcg) ACTH stimulation test
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.
Other: Overnight metyrapone test
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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02368379
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|