Actively Recruiting

Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT07168122

Establishment and Clinical Application of Reference Intervals of Salivary Cortisol

Led by Shanghai 6th People's Hospital · Updated on 2025-09-11

220

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Establishment and Clinical Application of Reference Intervals of Salivary Cortisol

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 60 years for healthy volunteers
  • Body mass index (BMI) 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: fasting blood glucose below 5.6 mmol/L, 2-hour blood glucose after glucose load below 7.8 mmol/L, and glycated hemoglobin (HbA1c) below 5.7%
  • Age between 18 and 80 years for patients with suspected Cushing's syndrome or adrenal insufficiency
Not Eligible

You will not qualify if you...

  • Liver or kidney dysfunction with elevated liver enzymes or serum creatinine above 115 bcmol/L
  • Pregnancy or breastfeeding, cancer, or mental illness
  • Conditions affecting cortisol levels such as hypothalamus-pituitary-adrenal axis disease, autoimmune diseases, diagnosed mental diseases, Alzheimer's disease, alcoholism (alcohol over 60 g/day for men or over 40 g/day for women), or corticosteroid therapy in the past 3 months (including contraceptives or estrogen in females)
  • Serious oral problems affecting saliva collection such as oral ulcers or gingival bleeding
  • Night shift workers awake from 11:00 PM to 7:00 AM
  • Acute infection with body temperature 37.3 �b0C or higher or C-reactive protein over 50 mg/L
  • Corticosteroid therapy within the last 6 weeks for patients
  • Severe liver and kidney dysfunction
  • Alcoholism, depression, or other psychiatric disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China, 200233

Actively Recruiting

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Research Team

J

Jian Zhou, Doctor

CONTACT

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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Establishment and Clinical Application of Reference Intervals of Salivary Cortisol | DecenTrialz