๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Healthy Volunteers:
Inclusion Criteria:
1. Age โฅ 18 and โค 60 years old;
2. Body mass index (BMI) โฅ 18.5 and โค 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 ฮผmol/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 โฅ 37.3 โ 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.