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 testPrescence 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
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