Status:
RECRUITING
Establishment and Clinical Application of Reference Intervals of Salivary Cortisol
Lead Sponsor:
Shanghai 6th People's Hospital
Conditions:
Healthy Adult
Cushing Syndrome
Eligibility:
All Genders
18-80 years
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.
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 reflec...
Eligibility Criteria
Inclusion
- Healthy Volunteers:
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT07168122
Start Date
September 1 2025
End Date
December 31 2027
Last Update
September 11 2025
Active Locations (1)
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1
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China, 200233