Measuring body clock genes in people with cortisol-related hormone disorders
Tests body clock gene activity in blood cells of adults with cortisol disorders.
Plain-language title generated from the registry record
Registry title: Clinical Study on Circadian Genes Dysregulation in Patients With Glucocorticoid Disorders
Key facts
- Where
- Roma, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT04374721, who can take part
Where in Italy
- Department of Experimental Medicine, "Sapienza" University of RomeRoma, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Roma La Sapienza
- Trial code
- NCT04374721
- Record updated
- 20 October 2026
- Original description
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)Read full original descriptionShow less
Clinical Study on Circadian Genes Dysregulation in Patients With Glucocorticoid Disorders
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)
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: 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; 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; acute adrenal insufficiency; 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; 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; clinical or laboratory signs of significant respiratory, hepatobiliary, or pancreatic disease; pregnancy; BMI greater than 40 kg/m²; night-shift workers.