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Salivary Cortisol Measurements by Mass Spectrometry

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ClinicalTrials.gov Identifier: NCT02162706
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Tandy Aye, Stanford University

Brief Summary:
Cortisol is a hormone critical for survival in times of stress. Currently most measurements are done with blood samples. The hypothesis of this study is cortisol measured from saliva using mass spectrometry can be used to replace measurements by blood.

Condition or disease Intervention/treatment
Endocrine Disorders Other: Non intervention study

Detailed Description:
Cortisol levels change depending on the time of day. Salivary samples were collected from health controls at bedtime, midnight and first morning waking on two consecutive nights and salivary cortisol levels were measured using mass spectrometry. In a patients with possible endocrine disorders who were going through an adrenocortiotropin stimulation test for adrenal insufficiency, salivary cortisol was measured prior to giving cosyntropin and 30-40 minutes after cosyntropin.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Pilot Study of Salivary Cortisol Measurements by Mass Spectrometry
Study Start Date : June 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016



Primary Outcome Measures :
  1. Salivary Cortisol [ Time Frame: All collections are done within 48 hours ]

Biospecimen Retention:   Samples Without DNA
Saliva was collected using Salivabio children's swab (SCS).


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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with possible endocrine disorders seen during outpatient pediatric endocrinology visit or inpatient consultations. Healthy controls were open to the general public in California.
Criteria

Inclusion Criteria:

  • Normal subjects
  • Subjects with possible endocrine disorder

Exclusion Criteria:

  • Tracheostomy or ventilator dependent
  • Gastrotomy tubed dependent or unable to eat/drink by mouth

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): NCT02162706


Locations
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United States, California
Lucile Packard Children's Hospital and Stanford Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Tandy Aye, MD Stanford University
Publications of Results:
Other Publications:
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Responsible Party: Tandy Aye, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02162706    
Other Study ID Numbers: Salivary Cortisol
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Endocrine System Diseases