Actively Recruiting
Study for Reference Intervals and Optimal Cut-offs for Salivary Cortisol
Led by Shanghai 6th People's Hospital · Updated on 2025-09-11
220
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying salivary cortisol levels to develop normal reference ranges and identify optimal cut-off points for diagnosing Cushing's syndrome and adrenal insufficiency. This observational study aims to help improve the use of saliva tests, which provide a non-invasive way to measure cortisol, a hormone important for assessing endocrine health. The study uses advanced methods to measure very low cortisol levels accurately, addressing challenges in current testing techniques. Participants include three groups: healthy volunteers, patients diagnosed with Cushing's syndrome, and patients with adrenal insufficiency. The study will collect saliva samples at specific times (8:00, 16:00, and 23:00) to establish reference intervals in healthy individuals and determine diagnostic cut-offs in patients. Two new testing technologies will be evaluated for clinical use, including a simplified immunomagnetic-bead-based assay and a fluorescence immunoassay suitable for point-of-care testing. During the study, participants will provide saliva samples at specified times on the day of collection. Researchers will analyze the samples to measure cortisol levels and compare results among groups by age, sex, and body mass index. The primary outcomes include establishing normal cortisol ranges and diagnostic accuracy for the conditions studied. The study will continue until the end of 2027, with careful monitoring of results to support clinical adoption of these new saliva testing methods.
CONDITIONS
Brief Title
Establishment and Clinical Application of Reference Intervals of Salivary Cortisol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers aged 18 to 60 years
- Body mass index between 18.5 and 24.9 kg/m2
- No history of chronic diseases such as hyperglycemia, hypertension, dyslipidemia, coronary heart disease, or stroke
- Normal glucose regulation defined by fasting blood-glucose < 5.6 mmol/L, 2-hour blood-glucose after glucose load < 7.8 mmol/L, and glycated hemoglobin (HbA1c) < 5.7%
- Patients aged 18 to 80 years suspected of having Cushing's syndrome or adrenal insufficiency
You will not qualify if you...
- Liver or kidney dysfunction with elevated liver enzymes or serum creatinine > 115 µmol/L
- Pregnancy or lactation, cancer, or mental illness
- Conditions affecting cortisol levels such as hypothalamus-pituitary-adrenal axis disease, autoimmune diseases, diagnosed mental disease, Alzheimer's disease, alcoholism above specified limits, or corticosteroid therapy in the past 3 months
- Serious oral problems like ulcers or gingival bleeding
- Night shift workers awake from 11:00 PM to 7:00 AM
- Acute infection with body temperature ≥ 37.3 °C or elevated C-reactive protein > 50 mg/L
- Corticosteroid therapy within the last 6 weeks for patients
- Depression or other psychiatric disorders for patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants provide saliva samples at specific times during the day to measure cortisol levels using advanced testing methods.
1 visit (in-person) with saliva collection at 8:00, 16:00, and 23:00
Duration - Up to 5 years
Participants' salivary cortisol levels are assessed to establish reference intervals and evaluate diagnostic accuracy for endocrine conditions.
No additional visits; data collected from initial samples and clinical records
Trial Site Locations
Total: 1 location
1
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China, 200233
Actively Recruiting
Research Team
J
Jian Zhou, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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