Actively Recruiting
Phase II Prospective Evaluation of Desmopressin Stimulation Test Performance in ACTH-Dependent Cushing Syndrome
Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-12
140
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying Cushing syndrome (CS), a condition caused by excess production of adrenocorticotropic hormone (ACTH) leading to high cortisol levels. This can cause serious health problems like diabetes, high blood pressure, weight gain, and mood changes. The study aims to improve the diagnostic accuracy of the desmopressin stimulation test (DesmoST) in identifying specific types of ACTH-dependent CS, including Cushing disease (CD) and ectopic ACTH syndrome (EAS). Participants with CS will undergo three DesmoSTs at least 48 hours apart, with specific procedures including limiting fluid intake before each test and fasting for 12 hours. One test involves taking a dexamethasone pill the night before. Desmopressin is given through an intravenous needle, and blood samples are collected six times around the test. Healthy volunteers will have four DesmoSTs spaced 2 to 14 days apart, following similar protocols. During the study, participants will have follow-up visits 3 to 5 days after each test, possibly by phone. Researchers will measure hormone responses at multiple time points to assess test accuracy and explore factors affecting results. The study also evaluates biomarkers like Factor VIII and examines the relationship between fluid status and hormone response. The total participation period varies with test schedules and follow-ups.
CONDITIONS
Brief Title
Desmopressin Stimulation Test Performance in ACTH-Dependent Cushing Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years
- Agree to follow lifestyle considerations during the study
- Acceptable recent lab results: hematocrit ≥33%, plasma sodium 136-145 mmol/L, eGFR ≥60 ml/min/1.73 sq.m
- For those on drugs affecting sodium levels, normal plasma sodium within 7 days of first test
- Patients with possible ACTH-dependent Cushing Syndrome: evidence of hypercortisolemia and plasma ACTH >20 pg/mL
- Patients with recurrent ACTH-dependent Cushing Syndrome: evidence of previous remission and current ACTH-dependent hypercortisolism
- Healthy volunteers in good general health and stable condition
You will not qualify if you...
- Unable to comply with study procedures or visits
- Unable to understand or sign informed consent
- Allergy or hypersensitivity to desmopressin
- Pregnancy or breastfeeding
- History of angina, significant coronary artery disease, heart failure, or SIADH
- Uncontrolled hypertension (blood pressure >150/95 mmHg) before desmopressin
- Any condition that may jeopardize participation
- Current daily use of desmopressin, systemic glucocorticoids, vasopressors, or drugs interfering with desmopressin
- Use of strong CYP3A4 inducers or recent use of drugs worsening hyponatremia
- Chronic high fluid intake (>4 liters daily)
- Contraindication to intravenous catheter use
- Previous participation in this study
- History of any type of hemophilia
- Clinically significant abnormal lab values
- Specific exclusions for patient groups, including recent use of certain medications and treatments for Cushing Syndrome or diabetes insipidus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day assessment
Participants undergo the Desmopressin stimulation test under different conditions to evaluate hormonal response and improve diagnostic accuracy for ACTH-dependent Cushing syndrome.
1 visit (in-person) with multiple timed blood samples over 60 minutes
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
R
Raven N McGlotten, R.N.
L
Lynnette K Nieman, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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