Status:
UNKNOWN
Clinical Study on Circadian Genes Dysregulation in Patients With Glucocorticoid Disorders
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Cushing Syndrome
Adrenal Insufficiency
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 altera...
Detailed Description
This is an intervention, prospective, multicentric study. Enrolled patients will undergo 4 visits: * Adrenal insufficiency (AI) patients: patients affected by primary or secondary adrenal insufficie...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
July 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04374721
Start Date
July 4 2018
End Date
December 1 2023
Last Update
November 30 2022
Active Locations (1)
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1
Department of Experimental Medicine, "Sapienza" University of Rome
Roma, Italy, 00161