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

Adrenal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368379
• Other study ID #: 293113
• Status: Completed
• Phase: N/A
• First received: February 5, 2015
• Last updated: January 25, 2018
• Start date: March 2014
• Est. completion date: August 2016

Study information

• Verified date: January 2018
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Adrenal Insufficiency
• Hyperphagia
• Prader Willi Syndrome
• Prader-Willi Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of central adrenal insufficiency using low dose (1 mcg) ACTH stimulation test		40 minutes
Primary	Prescence of central adrenal insufficiency using overnight metyrapone test		8 hours
Secondary	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