Desmopressin Stimulation Test Performance in ACTH-Dependent Cushing Syndrome (NCT06635629) | Clinical Trial Compass
RecruitingPhase 2
Desmopressin Stimulation Test Performance in ACTH-Dependent Cushing Syndrome
United States140 participantsStarted 2024-12-12
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. A. Hypercortisolemia as evidenced by physician note or laboratory report: at least one screening modality (1 mg dexamethasone suppression test, 24-hour urinary free cortisol (UFC), bedtime or late night (2200h - 2359h) salivary or serum cortisol) within 4 weeks of screening. In patients suspected to have cyclic CS any previous abnormal result will suffice.
✓. A. Normal or increased plasma ACTH (\>20 pg/mL) as evidenced by physician note or laboratory report.
Exclusion criteria
✕. 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.
✕. A history of angina, significant coronary artery disease, congestive heart failure, or syndrome of inappropriate antidiuretic hormone secretion (SIADH), due to risk of fluid overload and/or hyponatremia.
✕
What they're measuring
1
ACTH and cortisol responses
Timeframe: -5, 0, 15, 30, 45 and 60 minutes
Trial details
NCT IDNCT06635629
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
. Uncontrolled hypertension (blood pressure \>150/95 mmHg) at screening and before desmopressin administration, due to risk of further increase if fluid overload occurs
✕. Any condition that in the opinion of the Investigator would jeopardize the participant s appropriate participation in this study.
✕. Current daily use of any of the following medications: