Status:
UNKNOWN
Screening and Stimulation Testing for Residual Secretion of Adrenal Steroid Hormones in Autoimmune Addison's Disease
Lead Sponsor:
University of Bergen
Collaborating Sponsors:
Karolinska Institutet
Charite University, Berlin, Germany
Conditions:
Primary Adrenal Insufficiency
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 des...
Detailed Description
Autoimmune destruction of the adrenal cortex is the main cause of primary adrenal insufficiency (Addison's disease, AD). Autoimmune AD (AAD) becomes clinically manifest when 90 % of cortex of adrenal ...
Eligibility Criteria
Inclusion
- Men and women with AAD, age 18-70 years old. This requires documented adrenal insufficiency and a positive test for 21-hydroxylase autoantibodies (biomarker for autoimmune cause) on at least one occasion.
- Provided written informed consent
- In case of concomitant endocrine/autoimmune diseases, the patients should be on stable adequate treatment at least the last 3 months prior to the study period.
- For Norwegian AD patients: enrolled in ROAS
- For Swedish AD patients: enrolled in the Swedish Addison registry
Exclusion
- Antihypertensive treatment, with the exception of doxazosin, verapamil, and moxonidine.
- Active malignant disease, severe heart, kidney or liver failure.
- Diabetes mellitus type 1.
- Pregnancy or breast feeding.
- Pharmacological treatment with glucocorticoids (except their usual cortisone or hydrocortisone replacement therapy) or drugs that interfere with cortisol and catecholamine metabolism (antiepileptics, rifampicin, St. Johns wart).
- Use of other glucocorticoid replacement medication than cortisone acetate or hydrocortisone.
- Intake of grapefruit, grapefruit juice, or and liquorice juice the last week before or during the study period.
Key Trial Info
Start Date :
September 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03793114
Start Date
September 26 2018
End Date
December 1 2025
Last Update
November 29 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Endokrinologie in Charlottenburg
Berlin, Germany, 10627
2
Haukeland University Hospital
Bergen, Norway, 5021
3
Karolinska Institutet
Stockholm, Sweden, 171 77