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RECRUITINGOBSERVATIONAL

Establishment and Clinical Application of Reference Intervals of Salivary Cortisol

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Healthy Volunteers: Who May Qualify: 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%. Who Should NOT Join This Trial: 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 conditions (where your immune system attacks your own body) (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: Who May Qualify: 1. Aged 18 to 80 years old; 2. Patients with suspected Cushing's syndrome or adrenal insufficiency. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Locations (1)

Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China