Establishment and Clinical Application of Reference Intervals of Salivary Cortisol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Healthy Adult, Cushing Syndrome, Adrenal Insufficiency. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study for Reference Intervals and Optimal Cut-offs for Salivary Cortisol
Overview
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.
Detailed description
Saliva testing is a non-invasive alternative to blood tests for measuring cortisol, a key hormone for assessing endocrine status and diagnosing conditions like Cushing's syndrome. It accurately reflects physiologically active free cortisol. However, its clinical use is hampered by extremely low cortisol concentrations and the lack of reliable detection methods. We have developed two advanced technologies: an immunomagnetic-bead-based LC-MS assay with simplified preparation, and a fluorescence immunoassay system for point-of-care testing. To promote their clinical adoption, this study will establish normal reference intervals of salivary cortisol for both methods in a healthy population and optimal cut-offs in cases of Cushing's sydrome and adrenal insufficiency.
Primary outcome measures
- Reference intervals of salivary cortisol [Time frame: 8:00, 16:00 and 23:00 on the day of sample collection]
- Optimal cut-off and diagnostic accuracy of salivary cortisol in Cushing's syndrome [Time frame: 23:00 on the day of sample collection]
- Optimal cut-off and diagnostic accuracy of salivary cortisol in adrenal insufficiency [Time frame: 8:00 on the day of sample collection]
- Comparison of diagnostic accuracy of salivary cortisol in Cushing's syndrome and adrenal insufficiency [Time frame: 8:00 or 23:00 on the day of sample collection]
Secondary outcome measures (4)
- Agreement in assessment of salivary cortisol [Time frame: 8:00, 16:00 and 23:00 on the day of sample collection]
- Between-groups differences in salivary cortisol of healthy volunteers with different age ranges [Time frame: 8:00, 16:00 and 23:00 on the day of sample collection]
- Between-groups differences in salivary cortisol of healthy volunteers with different sex [Time frame: 8:00, 16:00 and 23:00 on the day of sample collection]
- Between-groups differences in salivary cortisol of healthy volunteers with different body mass index ranges [Time frame: 8:00, 16:00 and 23:00 on the day of sample collection]
Eligibility criteria
Healthy Volunteers:
Inclusion criteria
- 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%.
Exclusion criteria
- 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);
- Night shift workers, who are awake from 11:00 PM to 7:00 AM;
- Acute infection (body temperature ≥ 37.3 ℃ or C-reactive protein > 50 mg/L).
Cases:
Inclusion criteria
- Aged 18 to 80 years old;
- Patients with suspected Cushing's syndrome or adrenal insufficiency.
Exclusion criteria
- Corticosteroid therapy within the last 6 weeks;
- Acute infection;
- Severe oral conditions;
- Severe liver and kidney dysfunction;
- Alcoholism, depression, or other psychiatric disorders.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Shanghai Sixth People's Hospital — Shanghai
Identifiers
NCT: NCT07168122 · 20250811