Improving Desmopressin Stimulation Test Accuracy for ACTH-Dependent Cushing Syndrome Phase II Study Evaluating Hormonal Responses in Cushing Disease and Ectopic ACTH Syndrome

What this Trial Is About

Cushing syndrome CS is a condition caused by the body producing too much adrenocorticotropic hormone ACTH, leading to excess cortisol. This excess cortisol can cause serious health problems such as diabetes, high blood pressure, weight gain, and mood changes. Diagnosing CS early is challenging, and the desmopressin stimulation test DesmoST is a diagnostic tool whose accuracy needs further study, especially in identifying specific types of ACTH-dependent CS like Cushing disease CD and ectopic ACTH syndrome EAS. The study evaluates how well the DesmoST works under different conditions. Participants with CS will undergo three DesmoSTs spaced at least 48 hours apart, with controlled fluid intake and fasting before each test. For one test, they will take a dexamethasone pill the night before. Desmopressin is delivered intravenously, and blood samples are taken multiple times before and after administration. Healthy volunteers will have four DesmoSTs spaced 2 to 14 days apart, with follow-up visits by phone or in person 3 to 5 days after each test. During the study, participants will limit fluids before testing and undergo blood draws at six time points around desmopressin administration. Researchers will measure hormone responses, including ACTH and cortisol changes, to assess test accuracy. They will also explore factors like fluid status and biomarkers such as Factor VIII. Participation involves multiple tests and follow-up visits, with all procedures monitored by the research team. The study aims to improve diagnostic methods for ACTH-dependent CS over several years.

Desmopressin Stimulation Test Performance in ACTH-Dependent Cushing Syndrome