Salivary Cortisol Measurements by Mass Spectrometry

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02162706
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Duration (Months): 33
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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	Phase
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.

Study Design

• 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: Jun 1, 2013
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Outcome Measures

Primary Outcome Measures

1. Salivary Cortisol [All collections are done within 48 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lucile Packard Children's Hospital and Stanford Clinics	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Tandy Aye, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Tandy Aye, Associate Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT02162706
• Other Study ID Numbers: Salivary Cortisol
• First Posted: Jun 13, 2014
• Last Update Posted: Nov 13, 2019
• Last Verified: Nov 1, 2019

• Additional relevant MeSH terms: Endocrine System Diseases

Study Results

No Results Posted as of Nov 13, 2019