Clinical Trial: Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome
Brief 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.
Detailed Summary:
Sponsor: Nationwide Children's Hospital
Current 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 ]
Original Primary Outcome: Same as current
Current 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 ]
Original Secondary Outcome: Same as current
Information By: Nationwide Children's Hospital
Dates:
Date Received: February 5, 2015
Date Started: March 2014
Date Completion: June 2016
Last Updated: February 16, 2015
Last Verified: February 2015
