Establishment and Clinical Application of Reference Intervals of Salivary Cortisol
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorShanghai 6th People's Hospital
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.
Eligibility criteria
Qualifiers
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%.
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Not listed
Trial groups
220 Participants
are grouped into 3 trial groupsSponsors and collaborators
Source ClinicalTrials.gov