Salivary Cortisol Measurements by Mass Spectrometry

NCT ID: NCT02162706

Last Updated: 2019-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Endocrine Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Non intervention study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Tandy Aye

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tandy Aye, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Lucile Packard Children's Hospital and Stanford Clinics

Stanford, California, United States

Site Status

Countries

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United States

References

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Deutschbein T, Unger N, Mann K, Petersenn S. Diagnosis of secondary adrenal insufficiency: unstimulated early morning cortisol in saliva and serum in comparison with the insulin tolerance test. Horm Metab Res. 2009 Nov;41(11):834-9. doi: 10.1055/s-0029-1225630. Epub 2009 Jul 7.

Reference Type BACKGROUND
PMID: 19585406 (View on PubMed)

Baid SK, Sinaii N, Wade M, Rubino D, Nieman LK. Radioimmunoassay and tandem mass spectrometry measurement of bedtime salivary cortisol levels: a comparison of assays to establish hypercortisolism. J Clin Endocrinol Metab. 2007 Aug;92(8):3102-7. doi: 10.1210/jc.2006-2861. Epub 2007 Jun 5.

Reference Type BACKGROUND
PMID: 17550962 (View on PubMed)

Chao CS, Shi RZ, Kumar RB, Aye T. Salivary cortisol levels by tandem mass spectrometry during high dose ACTH stimulation test for adrenal insufficiency in children. Endocrine. 2020 Jan;67(1):190-197. doi: 10.1007/s12020-019-02084-8. Epub 2019 Sep 18.

Reference Type RESULT
PMID: 31535345 (View on PubMed)

Other Identifiers

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Salivary Cortisol

Identifier Type: -

Identifier Source: org_study_id

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