Clinical Study on Circadian Genes Dysregulation in Patients With Glucocorticoid Disorders (CHROnOS)
Cushing Syndrome, Adrenal Insufficiency, Cushing Disease
About this trial
This is an interventional other trial for Cushing Syndrome focused on measuring circadian rhythm, circadian genes, circadian clock, glucocorticoids, cortisol
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
Sites / Locations
- Department of Experimental Medicine, "Sapienza" University of RomeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Patients with Adrenal Insufficiency
Patients with Cushing's Syndrome
Healthy Controls
Patients with Adrenal Insufficiency established or newly diagnosed, under glucocorticoid replacement therapy.
patients with adrenocorticotropic hormone (ACTH)-dependent or ACTH-independent Cushing's Syndrome diagnosis during active disease (new diagnosis or recidivating) at enrollment.
Age-, sex- and BMI- matched patients referring to our center for diagnostic procedures not affected by Adrenal Insufficiency or Cushing's Syndrome.