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ACTIVE NOT RECRUITING
NCT03793114
NA

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

Sponsor: University of Bergen

View on ClinicalTrials.gov

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 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?

Official title: Residual Secretion of Adrenal Steroid Hormones in Addison's Disease

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2018-09-26

Completion Date

2029-12-31

Last Updated

2026-05-08

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Cosyntropin stimulation test

Blood samples are taken before (0 min), and 30 and 60 min after intravenously administration of 250 µg cosyntropin (tetracosactide acetate) with the patient placed in the recumbent position. The test will be performed non-fasting (but medication-fasting) between 08:00 and 10:00 a.m.

DIAGNOSTIC_TEST

Baseline blood tests

Medication-fasting morning levels of adrenocortical hormones.

DEVICE

30-hour ambulatory sampling of intestinal fluid

30-hour ambulatory sampling of intestinal fluid for analysis of adrenocortical hormones.

OTHER

Blood test

Cardiovascular and inflammatory biomarker profiles

Locations (3)

Endokrinologie in Charlottenburg

Berlin, State of Berlin, Germany

Haukeland University Hospital

Bergen, Bergen, Norway

Karolinska Institutet

Stockholm, Stockholm County, Sweden