RecruitingNCT07168122
Establishment and Clinical Application of Reference Intervals of Salivary Cortisol
Study for Reference Intervals and Optimal Cut-offs for Salivary Cortisol
Sponsor
Shanghai 6th People's Hospital
Enrollment
220 participants
Start Date
Sep 1, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
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
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria7
- Healthy Volunteers:
- 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 Criteria12
- 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);
- Night shift workers, who are awake from 11:00 PM to 7:00 AM;
- Acute infection (body temperature ≥ 37.3 ℃ or C-reactive protein \> 50 mg/L).
- Cases:
- Corticosteroid therapy within the last 6 weeks;
- Acute infection;
- Severe oral conditions;
- Severe liver and kidney dysfunction;
- Alcoholism, depression, or other psychiatric disorders.
Interested in this trial?
Get notified about updates and connect with the research team.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07168122
Related Trials
Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome
NCT0370890015 locations
Human Repeat Insult Patch Test to Evaluate Skin Irritation and Sensitization in Healthy Volunteers
NCT074736611 location
Investigating Specific Gait Patterns in Individuals Living With Multiple Sclerosis
NCT073889921 location
This Study Evaluates Skin Response Following Application of a Collagen-based Material in Healthy Adult Volunteers Using a Standardized Skin Prick Test. Skin Responses Will be Assessed at Multiple Time Points Following Application, and the Study is Intended to Evaluate Dermal Safety.
NCT074736741 location
Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency
NCT054357813 locations