Clinical Trials in China / NCT07168122
Recruiting
Observational
Establishment and Clinical Application of Reference Intervals of Salivary Cortisol
NCT07168122 · tracked via the Priya Life Science China tracker
Condition(s) studied
Healthy AdultCushing SyndromeAdrenal Insufficiency
Study summary
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
Healthy Volunteers:
Inclusion Criteria:
1. Age ≥ 18 and ≤ 60 years old;
2. Body mass index (BMI) ≥ 18.5 and ≤ 24.9 kg\*m\^-2;
3. No previous history of chronic diseases such as hyperglycemia, hypertension, dyslipidemia, coronary heart disease and stroke;
4. 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:
1. 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;
2. Pregnancy or lactation women, or people with cancer or mental illness;
3. 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);
4. Factors affecting saliva collection, such as serious oral problems (oral ulcers, gingival bleeding);
5. Night shift workers, who are awake from 11:00 PM to 7:00 AM;
6. Acute infection (body temperature ≥ 37.3 ℃ or C-reactive protein \> 50 mg/L).
Cases:
Inclusion Criteria:
1. Aged 18 to 80 years old;
2. Patients with suspected Cushing's syndrome or adrenal insufficiency.
Exclusion Criteria:
1. Corticosteroid therapy within the last 6 weeks;
2. Acute infection;
3. Severe oral conditions;
4. Severe liver and kidney dysfunction;
5. Alcoholism, depression, or other psychiatric disorders.
Primary outcome measure(s)
- Reference intervals of salivary cortisol — 8:00, 16:00 and 23:00 on the day of sample collection
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. - Optimal cut-off and diagnostic accuracy of salivary cortisol in Cushing's syndrome — 23:00 on the day of sample collection
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. - Optimal cut-off and diagnostic accuracy of salivary cortisol in adrenal insufficiency — 8:00 on the day of sample collection
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. - Comparison of diagnostic accuracy of salivary cortisol in Cushing's syndrome and adrenal insufficiency — 8:00 or 23:00 on the day of sample collection
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07168122 on ClinicalTrials.gov ↗ ← All trials in China