Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT06635629

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

211 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Desmopressin Stimulation Test Performance in ACTH-Dependent Cushing Syndrome

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years
  • Willingness to follow study lifestyle guidelines
  • Acceptable lab results within 4 weeks before first test: hematocrit >=33%, plasma sodium 136-145 mmol/L, eGFR >=60 ml/min/1.73 sq.m
  • For those on drugs that may cause low sodium, normal plasma sodium within 7 days before first test
  • For patients with possible ACTH-dependent CS: documented hypercortisolemia, and normal or elevated plasma ACTH (>20 pg/mL)
  • For patients with recurrent ACTH-dependent CS: prior remission after tumor removal, current ACTH-dependent hypercortisolism, and willingness for repeat surgery
  • For healthy volunteers: good general health with no acute illness
Not Eligible

You will not qualify if you...

  • Inability to comply with study procedures or provide informed consent
  • Allergy or hypersensitivity to desmopressin
  • Pregnancy or breastfeeding
  • History of angina, significant coronary disease, heart failure, or SIADH
  • Uncontrolled high blood pressure (>150/95 mmHg) at screening
  • Use of desmopressin, systemic glucocorticoids, vasopressors, or drugs affecting desmopressin action
  • Use of strong CYP3A4 inducers or certain medications worsening hyponatremia within specified time frames
  • Chronic excessive hydration (>4 liters per day)
  • Contraindications to intravenous catheter use
  • Previous participation in this study
  • History of any type of hemophilia
  • Clinically significant abnormal lab values at screening
  • Specific exclusions for CS patients including recent use of medications blocking glucocorticoid production or action, use of mitotane, long-acting octreotide or pasireotide, or treatment of diabetes insipidus
  • For healthy volunteers: recent glucocorticoid use or hemoglobin A1c >=6.5%

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

R

Raven N McGlotten, R.N.

CONTACT

L

Lynnette K Nieman, M.D.

CONTACT

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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