Clinical Study on Circadian Genes Dysregulation in Patients With Glucocorticoid Disorders
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
Italy
Department of Experimental Medicine, Sapienza University of Rome
RECRUITING
Roma
Contact Information
Primary
Andrea Isidori, MD,PhD
andrea.isidori@uniroma1.it
0039649970711
Time Frame
Start Date: 2018-07-04
Estimated Completion Date: 2029-12-01
Participants
Target number of participants: 44
Treatments
Experimental: Patients with Adrenal Insufficiency
Patients with Adrenal Insufficiency established or newly diagnosed, under glucocorticoid replacement therapy.
Experimental: Patients with Cushing's Syndrome
patients with adrenocorticotropic hormone (ACTH)-dependent or ACTH-independent Cushing's Syndrome diagnosis during active disease (new diagnosis or recidivating) at enrollment.
Experimental: Healthy Controls
Age-, sex- and BMI- matched patients referring to our center for diagnostic procedures not affected by Adrenal Insufficiency or Cushing's Syndrome.
Experimental: Arm 4 - Participants with Obesity
Adults with obesity (BMI ≥30 kg/m²), with or without metabolic syndrome, enrolled to investigate circadian, endocrine, immune, and metabolic alterations associated with obesity.
Experimental: Arm 5 - Patients Receiving Exogenous Glucocorticoids
Adults initiating systemic glucocorticoid therapy for non-endocrine conditions, including rheumatologic or respiratory disorders. Participants will undergo baseline assessment before treatment initiation, followed by assessments after 2-3 weeks and 2-3 months, with optional follow-up at 6 and 12 months.
Related Therapeutic Areas
Sponsors
Leads: University of Roma La Sapienza