💬In plain words
What the trial is, and whether it could suit you
This is a multicentric, prospective, intervention study on circadian genes expression in peripheral blood mononuclear cells as biomarkers of circadian rhythm derangement in patients affected by alterations of endogenous glucocorticoids secretion (Cushing's Syndrome during active phase, treatment and under remission and newly or on established glucocorticoid replacement therapy adrenal insufficiency)
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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); (except for the exogenous glucocorticoid cohort)
* alcoholism and/or drug addictions;
* night-shift workers;
* 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.
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