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

Nationwide Children's Hospital

Status: Completed

Conditions: Adrenal Insufficiency; Prader Willi Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02368379

293113

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Assessment of Central Adrenal Insufficiency

Other group

Description:

Patients will undergo low dose ACTH stimulation test followed by overnight metyrapone test to assess for central adrenal insufficiency.

Treatment:

Other: Overnight metyrapone test

Other: Low dose (1 mcg) ACTH stimulation test