Assessment of Diurnal Salivary Cortisol Production in COVID-19
NCT ID: NCT04988269
Last Updated: 2021-08-03
Study Results
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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COMPLETED
85 participants
OBSERVATIONAL
2021-04-15
2021-07-28
Brief Summary
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Detailed Description
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Age and gender matched healthy individuals without COVID-19 who had never been treated with GCs and fulfilled the exclusion criteria were also recruited from the Hospital's personnel and included in the analysis as Controls.
Blood samples were obtained immediately upon admission for the measurements of ACTH, IL-6 and aldosterone, which were performed by electrochemiluminescence assays on the cobas e 801 immunoassay analysers (Roche Diagnostics GmbH). Salivary samples for free cortisol and DHEAS were obtained during the next day using the Salivette (Sarstedt, Nümbrecht, Germany) at different time points 0800, 12.00, 18.00, and 22.00. Within 24h after saliva collection the salivettes were centrifuged at 2400 g for 20 min in 4 °C and aliquots were stored at -80 °C and analyzed by an Immunochemiluminescence assay in a Roche COBAS E411 analyzer.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients (Cases)
Adult consecutive patients that visited the Emergency Department of LAIKO General Hospital of Athens, Greece from May to July 2021 due to confirmed COVID-19 and related symptomatology.
Blood sampling on the day of admission (one time point) and saliva sampling at 4 different time points (0.800, 12.00, 18.00,22.00) the next day (all sampling in one day).
Blood sampling
Assessment of circulating levels of plasma ACTH, plasma aldosterone and serum interleukin -6 levels at day 1
Saliva sampling
Assessment of diurnal variation of cortisol and DHEA levels in the saliva at 4 different time points during the day (0.800, 12.00, 18.00, 22.00) at day 2.
Healthy Controls
Age and gender matched healthy individuals without COVID-19. Blood sampling (at day 1) and saliva sampling at different time points (0.800, 12.00, 18.00,22.00) the next day (all sampling in one day-day 2).
Blood sampling
Assessment of circulating levels of plasma ACTH, plasma aldosterone and serum interleukin -6 levels at day 1
Saliva sampling
Assessment of diurnal variation of cortisol and DHEA levels in the saliva at 4 different time points during the day (0.800, 12.00, 18.00, 22.00) at day 2.
Interventions
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Blood sampling
Assessment of circulating levels of plasma ACTH, plasma aldosterone and serum interleukin -6 levels at day 1
Saliva sampling
Assessment of diurnal variation of cortisol and DHEA levels in the saliva at 4 different time points during the day (0.800, 12.00, 18.00, 22.00) at day 2.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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National and Kapodistrian University of Athens
OTHER
Responsible Party
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Maria Yavropoulou
Senior Endocrinology Consultant
Locations
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Medical School, National and Kapodistrian University of Athens
Athens, , Greece
Countries
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References
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Yavropoulou MP, Filippa MG, Mantzou A, Ntziora F, Mylona M, Tektonidou MG, Vlachogiannis NI, Paraskevis D, Kaltsas GA, Chrousos GP, Sfikakis PP. Alterations in cortisol and interleukin-6 secretion in patients with COVID-19 suggestive of neuroendocrine-immune adaptations. Endocrine. 2022 Feb;75(2):317-327. doi: 10.1007/s12020-021-02968-8. Epub 2022 Jan 18.
Other Identifiers
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Ε.Σ 310
Identifier Type: -
Identifier Source: org_study_id
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