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

Information source: Nationwide Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prader Willi Syndrome; Adrenal Insufficiency

Intervention: Low dose (1 mcg) ACTH stimulation test (Other); Overnight metyrapone test (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Nationwide Children's Hospital

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.

Clinical Details

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

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome:

Presence of central adrenal insufficiency using low dose (1 mcg) ACTH stimulation test

Prescence of central adrenal insufficiency using overnight metyrapone test

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.

Eligibility

Minimum age: 2 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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).

Locations and Contacts

Nationwide Children's Hospital, Columbus, Ohio 43205, United States; Recruiting
Kathryn S. Obrynba, MD, Phone: 614-722-4425, Email: kathryn.obrynba@nationwidechildrens.org
Kathryn S. Obrynba, MD, Sub-Investigator
Manmohan Kamboj, MD, Principal Investigator
Additional Information

Starting date: March 2014
Last updated: February 16, 2015

Page last updated: August 23, 2015

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