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โ† Trials
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Establishment and Clinical Application of Reference Intervals of Salivary Cortisol

Recruitingn/aAges 18 Years - 80 YearsAllShanghai 6th People's Hospital
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In 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.

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๐Ÿ“‹ Eligibility rules (as published)
Healthy Volunteers: Inclusion Criteria: 1. Age โ‰ฅ 18 and โ‰ค 60 years old; 2. Body mass index (BMI) โ‰ฅ 18.5 and โ‰ค 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 โ‰ฅ 37.3 โ„ƒ 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.
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What it tests

  • Not listed
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Where

1 site
Shanghai Sixth People's Hospital
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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