Clinical trial: Clinical Study on Circadian Genes Dysregulation in Patients With Glucocorticoid Disorders (NCT04374721)

Eligibility criteria:
Inclusion Criteria:

          -  Primary or secondary chronic adrenal insufficiency, previously or newly diagnosed.

          -  ACTH-dependent or ACTH-independent Cushing's Syndrome diagnosis during active disease
             (new diagnosis or recidivating).

               -  Signed informed consent to participate in the study.

        Exclusion Criteria:

        - acute adrenal insufficiency;

          -  clinical or laboratory signs of significant respiratory, hepatobiliary, or pancreatic
             disease;

          -  pregnancy;

          -  severe infections, surgery, trauma requiring hospitalization within 3 months before
             study entry;

          -  any active blood or rheumatic disorders, and active liver disease in the previous 5
             years;

          -  clinically significant chronic kidney disease;

          -  severe psychiatric diseases;

          -  history of neoplasms in the last 5 years (except for adrenal or pituitary adenoma in
             Cushing Syndrome, pituitary adenoma or related neolpasms in secondary adrenal
             insufficiency);

          -  heart disease with a class III or class IV functional capacity;

          -  BMI greater than 40 kg/m²;

          -  use of medication that interferes with cortisol metabolism within 1 month before study
             entry;

          -  treatment with systemic Glucocorticoid (GC) therapy other than hydrocortisone (HC), or
             cortisone acetate (CA);

          -  alcoholism and/or drug addictions;

          -  night-shift workers;

          -  use of melatonin, antipsychotic medications, estroprogestinic preparations
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 80 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? Contradiction