Clinical Study on Circadian Genes Dysregulation in Patients With Glucocorticoid Disorders (NCT04374721) | Clinical Trial Compass
UnknownNot Applicable
Clinical Study on Circadian Genes Dysregulation in Patients With Glucocorticoid Disorders
Italy44 participantsStarted 2018-07-04
Plain-language 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 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)
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Circadian genes CLOCK and ARNTL expression evaluation