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Establishment and Clinical Application of Reference Intervals of Salivary Cortisol

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Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Source: NCT07168122, who can take part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
Shanghai 6th People's Hospital
Trial code
NCT07168122
Record updated
11 September 2025
Original description
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.Read full original descriptionShow less

Study for Reference Intervals and Optimal Cut-offs for Salivary Cortisol

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.

Inclusion: 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%; Aged 18 to 80 years old; Patients with suspected Cushing's syndrome or adrenal insufficiency.

Exclusion: Corticosteroid therapy within the last 6 weeks; 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); Acute infection (body temperature ≥ 37.3 ℃ or C-reactive protein > 50 mg/L); Cases:; Acute infection; Severe oral conditions; Alcoholism, depression, or other psychiatric disorders; 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; Night shift workers, who are awake from 11:00 PM to 7:00 AM; Severe liver and kidney dysfunction.

Healthy Volunteers:.

ClinicalTrials.gov NCT07168122