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Screening and Stimulation Testing for Residual Secretion of Adrenal Steroid Hormones in Autoimmune Addison's Disease

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion dates: Dec 2025 to Dec 31, 2029
    • Site details revised at 3 of 3 sites
    v7
  2. Primary completion date: Dec 2023 to Dec 2025
    • Study completion date: Apr 2024 to Dec 2025
    v6
  3. Primary completion date: Mar 2022 to Dec 2023v5
  4. Primary completion date: Apr 2020 to Mar 2022v4 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Apr 2020 to Apr 2024
    • Interventions: 30-hour ambulatory sampling of intestinal fluid (Device), Baseline blood tests (Diagnostic Test), Cosyntropin stimulation test (Diagnostic… to 30-hour ambulatory sampling of intestinal fluid (Device), Baseline blood tests (Diagnostic Test), Blood test (Other), Cosyntropin…
    • Site details revised at 3 of 3 sites
    • Study arms: 7 to 8
  5. Primary and study completion dates: Sep 2020 to Apr 2020v3
  6. Interventions: Cosyntropin stimulation test (Diagnostic Test) to 30-hour ambulatory sampling of intestinal fluid (Device), Baseline blood tests (Diagnostic Test), Cosyntropin stimulation test (Diagnostic…v2 Show 4 more changesShow less
    • Eligibility criteria revised
    • Secondary endpoints revised (34)
    • Study description expanded, about 74 words
    • Study arms: 3 to 7
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In autoimmune adrenal insufficiency, or Addison's disease (AD), the immune system attacks the adrenal cortex. As a result, the adrenal cells producing hormones such as cortisol and aldosterone are destroyed, leaving the body with insufficient levels to meet its needs. The common perception is that upon diagnosis of Addison's disease, basically all adrenal hormone production has ceased. There have, however, been found a few individuals who preserve some residual secretion of cortisol even years after diagnosis. The objectives of this study is to find out how common it is, and to explore if residual function have impact on patient outcome. That is, do patients with and without residual function differ when it comes to quality of life, working ability, medication dosages, and risk of adrenal crisis?
Trial Details
NCT Number NCT03793114
Lead Sponsor University of Bergen
Collaborators: Karolinska Institutet, Charite University, Berlin, Germany
Conditions
(from sponsor)		 Primary Adrenal Insufficiency
Related terms Addison Disease
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov