Clinical trial: Objective Markers and New Indicators in AI Disease (OMNI-AID Study) (NCT03615859)

Eligibility criteria:
Inclusion Criteria:

          -  Aged 18 - 85 years

          -  Male or female

          -  Participants who are otherwise healthy enough to participate, as determined by
             pre-study medical history and physical examination

        Patient groups only:

          -  Diagnosed with AI for over 6 months according to standard diagnostic criteria or with
             a medical condition requiring acute high dose steroid therapy for anti-inflammatory
             purposes

          -  If diagnosed with AI, established on stable HC replacement or prednisolone
             replacement, dose not altered for at least 3 months

          -  Established on a stable dose of Fludrocortisone, if taking, dose not altered for at
             least 3 months

          -  Participants taking other hormone replacements (e.g. levothyroxine, testosterone or
             growth hormone in secondary adrenal insufficiency) are accepted providing that their
             replacement doses have not altered for at least 3 months

          -  Participants who are able and willing to give written informed consent to participate
             in the study.

        Exclusion Criteria:

          -  Participants with a diagnosis of Type 1 or Type 2 diabetes mellitus.

          -  Unable to give informed consent.

          -  Excessive caffeine intake above 500 mg per day.

          -  Taking supplements or herbal medications that the participant is unwilling or unable
             to stop prior to and during the study period e.g. St John's Wort (may decrease
             prednisolone levels), Cat's claw, Echinacea (immunomodulatory properties).

          -  Currently taking medications that alter CYP3A4 metabolism of glucocorticoids that the
             participant is unwilling or unable to stop prior to and during the study period e.g.
             phenytoin, phenobarbital, rifampicin, rifabutin, carbamazepine, primidone,
             aminogluethimide, itraconazole, ketoconazole, ciclosporin or ritonavir.

          -  Pregnancy, taking the oral contraceptive pill, or oral oestrogen replacement therapy
             due to the effects on cortisol binding globulin levels and determination of
             prednisolone levels. Transdermal oestrogen replacement is permitted. Females of
             child-bearing age will be asked to provide a urine sample for a pregnancy test at each
             visit.

          -  Diagnosis of growth hormone deficiency, untreated

          -  History of any medical, psychological or other condition, or use of any medications,
             including over-the-counter products, which, in the opinion of the investigators, would
             either interfere with the study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 85 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