Clinical trial: Screening and Stimulation Testing for Residual Secretion of Adrenal Steroid Hormones in Autoimmune Addison's Disease (NCT03793114)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months.  She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs.  Physical examination shows a generalized increase in pigmentation of the skin.  Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease)

Patient description (patient's own words): I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy.

Does the patient match the trial criteria? Entailment