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

Not Applicable

Completed

• Conditions: Prader Willi Syndrome; Adrenal Insufficiency
• Interventions: Other: Low dose (1 mcg) ACTH stimulation test; Other: Overnight metyrapone test

• Registration Number: NCT02368379
• Lead Sponsor: Nationwide Children's Hospital

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 Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2015-02-05
• Study First Submitted QC: 2015-02-16
• Study First Posted: 2015-02-23
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Assessment of Central Adrenal Insufficiency	Low dose (1 mcg) ACTH stimulation test	Patients will undergo low dose ACTH stimulation test followed by overnight metyrapone test to assess for central adrenal insufficiency.
Assessment of Central Adrenal Insufficiency	Overnight metyrapone test	Patients will undergo low dose ACTH stimulation test followed by overnight metyrapone test to assess for central adrenal insufficiency.

Primary Outcome Measures

Name	Time	Method
Presence of central adrenal insufficiency using low dose (1 mcg) ACTH stimulation test	40 minutes
Prescence of central adrenal insufficiency using overnight metyrapone test	8 hours

Secondary Outcome Measures

Name	Time	Method
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.	0

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States