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

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?

Conditions

• Primary Adrenal Insufficiency

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

Sponsors & Collaborators

• Karolinska Institutet

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• University of Bergen

  lead OTHER

Principal Investigators

• Eystein S Husebye, M.D, Prof · University of Bergen

Study Design

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-26

Primary Completion

2029-12-31

Completion

2029-12-31

Countries

• Germany
• Norway
• Sweden

Study Locations