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Trial record 6 of 19 for:    "Secondary Adrenal Insufficiency" | "Respiratory System Agents"

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

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ClinicalTrials.gov Identifier: NCT02368379
Recruitment Status : Completed
First Posted : February 23, 2015
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Manmohan Kamboj, Nationwide Children's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Prader Willi Syndrome Adrenal Insufficiency Other: Low dose (1 mcg) ACTH stimulation test Other: Overnight metyrapone test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome
Study Start Date : March 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016


Arm Intervention/treatment
Assessment of Central Adrenal Insufficiency
Patients will undergo low dose ACTH stimulation test followed by overnight metyrapone test to assess for central adrenal insufficiency.
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.

Other: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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. [ Time Frame: 0 ]


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02368379


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital

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Responsible Party: Manmohan Kamboj, Associate Professor of Pediatrics, Section of Endocrinology, Metabolism and Diabetes, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02368379     History of Changes
Other Study ID Numbers: 293113
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Keywords provided by Manmohan Kamboj, Nationwide Children's Hospital:
Metyrapone
ACTH stimulation test
Additional relevant MeSH terms:
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Respiratory System Agents
Prader-Willi Syndrome
Adrenal Insufficiency
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders
Adrenal Gland Diseases
Endocrine System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Metyrapone
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists