Clinical Study on Circadian Genes Dysregulation in Patients With Glucocorticoid Disorders

Prior treatment

• 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;
• 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); (except for the exogenous glucocorticoid cohort)
• alcoholism and/or drug addictions;

Other illness

• \- acute adrenal insufficiency;
• 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;
• use of melatonin, antipsychotic medications, estroprogestinic preparations
  • Additional inclusion criteria introduced by Protocol Amendment Version 2.1 (approved 2026):
  • Adults with obesity (BMI ≥30 kg/m²), with or without metabolic syndrome. Adults initiating systemic glucocorticoid therapy for non-endocrine conditions, including respiratory or rheumatologic disorders.
  • Additional control participants, including euthyroid individuals with benign nodular thyroid disease, according to the amended protocol.

Lab values

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

Other

• pregnancy;
• BMI greater than 40 kg/m²;
• night-shift workers;

• 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.