Salivary Cortisol Measurements by Mass Spectrometry

Endocrine Disorders Clinical Trial

Official title:

Pilot Study of Salivary Cortisol Measurements by Mass Spectrometry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162706
• Other study ID #: Salivary Cortisol
• Status: Completed
• Start date: June 2013
• Est. completion date: March 2016

Study information

• Verified date: November 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Endocrine Disorders
• Endocrine System Diseases

Intervention

Other:
• Non intervention study

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital and Stanford Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Epub 2007 Jun 5. — View Citation

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. 2019 Sep 18. doi: 10.1007/s12020-019-02084-8. [Epub ahead of print] — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary Cortisol		All collections are done within 48 hours