Study to Establish Normal Salivary Cortisol Levels and Diagnostic Cut-offs for Cushings Syndrome and Adrenal Insufficiency

What this Trial Is About

Researchers are studying salivary cortisol levels to develop normal reference ranges and identify optimal cut-off points for diagnosing Cushings 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 Cushings syndrome, and patients with adrenal insufficiency. The study will collect saliva samples at specific times 800, 1600, and 2300 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.

Establishment and Clinical Application of Reference Intervals of Salivary Cortisol