About this trial
Background:
Cushing syndrome (CS) is a set of diseases that develop when the body produces too much adrenocorticotropic hormone (ACTH). ACTH stimulates the production of a hormone called cortisol. Excess cortisol can cause serious issues, such as diabetes, high blood pressure, weight gain, and mood changes. Diagnosing CS early can be difficult. One test used to diagnose CS, the desmopressin (Desmo) stimulation test (DesmoST), has not been studied in enough people to know how accurate it is.
Objective:
To find ways to improve the DesmoST. Researchers especially want to learn more about how well the DesmoST identifies people with specific ACTH CSs: Cushing disease (CD) and ectopic ACTH syndrome (EAS).
Eligibility:
People aged 18 to 70 years who have or may have CS, especially CD or EAS. Healthy volunteers are also needed.
Design:
Participants with CS will have 3 DesmoSTs at least 48 hours apart. The procedure for each is as follows:
They will limit their fluid intake the day before each test. They will have nothing to eat or drink for 12 hours before the test.
For 1 of the tests, they will take a pill that contains a hormone (dexamethasone). They will take it around 11 pm the day before the test.
Desmo is given through a tube attached to a needle inserted into a vein.
Blood will be drawn a total of 6 times before and after the desmo is given.
Healthy volunteers will have 4 DesmoSTs. These will be 2 to 14 days apart.
All participants will have follow-up visits 3 to 5 days after each test. These visits may be by phone.
Eligibility criteria
Qualifiers
Aged 18-70 years
Agreement to adhere to Lifestyle Considerations throughout the study.
Hematocrit at entry >=33 %
Plasma sodium 136-145 mmol/L (unless taking a drug that can cause hyponatremia, see below) eGFR >=60 ml/min/1.73 sq.m, calculated based on serum creatinine
Disqualifiers
Inability to comply with all study procedures and visits
Inability of subject to understand or to sign a written informed consent document.
Known allergy/hypersensitivity to desmopressin.
Pregnancy or lactation, due to alterations in measured serum cortisol and lack of data on desmopressin safety.
Trial design
Treatments tested in this trial
- Desmopressin
- Dexamethasone