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Completed

NCT Number: NCT02368379

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

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.

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Key information

Conditions

Prader Willi Syndrome Abnormalities, Multiple Adrenal Gland Diseases Adrenal Insufficiency Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Genetic Diseases, Inborn Imprinting Disorders Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Prader-Willi Syndrome

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Low dose (1 mcg) ACTH stimulation test

Other

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

Other

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.

Primary outcomes

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

    Time frame: 40 minutes

  2. Prescence of central adrenal insufficiency using overnight metyrapone test

    Time frame: 8 hours

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 23, 2015
Registry last updated
Jan 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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