Establishment and Clinical Application of Reference Intervals of Salivary Cortisol
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorShanghai 6th People's Hospital
About this trial
The goal of this observational study is to establish the normal reference intervals of salivary cortisol and optimal cut-offs for Cushing's sydrome and adrenal insufficiency.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 and ≤ 60 years old;
Body mass index (BMI) ≥ 18.5 and ≤ 24.9 kg*m^-2;
No previous history of chronic diseases such as hyperglycemia, hypertension, dyslipidemia, coronary heart disease and stroke;
Normal glucose regulation, defined as: fasting blood-glucose < 5.6 mmol/L, 2-hour blood-glucose after glucose load < 7.8 mmol/L, and glycated hemoglobin (HbA1c) < 5.7%.
Disqualifiers
Liver or kidney dysfunction, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or direct bilirubin higher than 1.5 times the upper limit of normal, or serum creatinine >115 μmol/L;
Pregnancy or lactation women, or people with cancer or mental illness;
Factors affecting cortisol levels, including hypothalamus-pituitary-adrenal axis disease, autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis, etc.), diagnosed mental disease, Alzheimer's disease, alcoholism (alcohol > 60 g/d for male, >40 g/d for women) and corticosteroid therapy in the past 3 months (females with contraceptives or estrogen);
Factors affecting saliva collection, such as serious oral problems (oral ulcers, gingival bleeding);
Trial population
The participants are enrolled from Shanghai Sixth People's Hospital, Shanghai.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
220 Participants
are grouped into 3 trial groupsGroup A: Heathy Volunteers
Group B: Cushing's sydrome
Group C: Adrenal insufficiency
Trial outcomes
Primary outcomes
1
Reference intervals of salivary cortisol
Salivary cortisol levels were evaluated by immunomagnetic-bead-based LC-MS assay and fluorescence immunoassay system to establish its reference intervals according to the 2.5th and 97.5th percentiles.
Time frame
8:00, 16:00 and 23:00 on the day of sample collection2
Optimal cut-off and diagnostic accuracy of salivary cortisol in Cushing's syndrome
The diagnostic cut-off for each analysis method was defined as either the calculated upper reference interval (97.5th percentile) or the optimal value determined by the Youden index. The sensitivity, specificity and area under curve for Cushing's syndrome was calculated using samples from all available healthy controls and cases.
Time frame
23:00 on the day of sample collection3
Optimal cut-off and diagnostic accuracy of salivary cortisol in adrenal insufficiency
The diagnostic cut-off for each analysis method was defined as either the calculated lower reference intervals (2.5th percentile) or the optimal value determined by the Youden index. The sensitivity, specificity and area under curve for adrenal insufficiency was calculated using samples from all available healthy controls and cases.
Time frame
8:00 on the day of sample collection4
Comparison of diagnostic accuracy of salivary cortisol in Cushing's syndrome and adrenal insufficiency
The diagnostic accuracies of the fluorescence immunoassay system and the immunomagnetic-bead-based LC-MS assay were compared by analyzing their areas under the receiver operating characteristic (ROC) curves using DeLong's test for paired statistics.
Time frame
8:00 or 23:00 on the day of sample collectionSecondary outcomes
1
Agreement in assessment of salivary cortisol
To assess the agreement in assessment of salivary cortisol between immunomagnetic-bead-based LC-MS assay and fluorescence immunoassay system
Time frame
8:00, 16:00 and 23:00 on the day of sample collection2
Between-groups differences in salivary cortisol of healthy volunteers with different age ranges
Comparsion of salivary cortisol levels in subgroups of age
Time frame
8:00, 16:00 and 23:00 on the day of sample collection3
Between-groups differences in salivary cortisol of healthy volunteers with different sex
Comparsion of salivary cortisol levels in subgroups of sex
Time frame
8:00, 16:00 and 23:00 on the day of sample collection4
Between-groups differences in salivary cortisol of healthy volunteers with different body mass index ranges
Comparsion of salivary cortisol levels in subgroups of body mass index
Time frame
8:00, 16:00 and 23:00 on the day of sample collectionSponsors and contacts
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Source ClinicalTrials.gov