NCT02368379

Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Nationwide Children's Hospital · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prader Willi Syndrome
• Adrenal Insufficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2015-02-23
• Last updated: 2018-01-29

Locations

1 site across 1 country: United States