NCT07168122 Establishment and Clinical Application of Reference Intervals of Salivary Cortisol
| NCT ID | NCT07168122 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai 6th People's Hospital |
| Condition | Healthy Adult |
| Study Type | OBSERVATIONAL |
| Enrollment | 220 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-06-30 |
Trial Parameters
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Brief 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 Criteria
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 wo