Desmopressin Stimulation Test Performance in ACTH-Dependent Cushing Syndrome

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT06635629
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cushing Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Desmopressin — DRUG
    Stimulates ACTH release in Cushing disease
  • Dexamethasone — DRUG
    Inhibits ACTH release in Cushing disease and healthy volunteers

Study Details

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.

Key Dates

Start date
Dec 12, 2024
Status verified
May 2026
Primary completion
Oct 1, 2028
Completion
Jan 1, 2029

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • Other: Desmopressin 10 mcg Ad-lib fluid
    Desmopressin 10 mcg Ad-lib fluidHealthy volunteers only
  • Active Comparator: Desmopressin 10 mcg NPO
    Desmopressin 10 mcg
  • Active Comparator: Desmopressin NPO 4 mcg
    Desmopressin 4 mcg
  • Active Comparator: Dexmopressin 10 mcg NPO + Dexamethasone
    Desmopressin 10 mcgDexamethasone 1 mg pretreatment

Primary Outcome Measure

ACTH and cortisol responses [ Time Frame: -5, 0, 15, 30, 45 and 60 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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