NCT07168122 Establishment and Clinical Application of Reference Intervals of Salivary Cortisol
| NCT ID | NCT07168122 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai 6th People's Hospital |
| Condition | Healthy Adult |
| Study Type | OBSERVATIONAL |
| Enrollment | 220 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 220 participants in total. It began in 2025-09-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07168122 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Healthy Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07168122 currently recruiting?
Yes, NCT07168122 is actively recruiting participants. Contact the research team at zhoujian@sjtu.edu.cn for enrollment information.
Where is the NCT07168122 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07168122 clinical trial?
NCT07168122 is sponsored by Shanghai 6th People's Hospital. The trial plans to enroll 220 participants.