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Clinical Trials in Norway / NCT03793114
Active, not recruiting Not applicable

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

NCT03793114 · tracked via the Priya Life Science Norway tracker
Sponsor
University of Bergen
Phase
Not applicable
Started
2018-09-26
Last updated
2026-05-08

Condition(s) studied

Primary Adrenal Insufficiency

Investigational drug(s) / intervention(s)

Cosyntropin stimulation testBaseline blood tests30-hour ambulatory sampling of intestinal fluidBlood 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.

Baseline blood tests: Medication-fasting morning levels of adrenocortical hormones.

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

Blood test: Cardiovascular and inflammatory biomarker profiles

Study 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?

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Endokrinologie in Charlottenburg Berlin State of Berlin
Haukeland University Hospital Bergen Bergen
Karolinska Institutet Stockholm Stockholm County

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03793114 on ClinicalTrials.gov ↗ ← All trials in Norway