Circadian Gene Changes in People with Glucocorticoid Disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective interventional study enrolls adults with adrenal insufficiency or Cushing's syndrome, and matched healthy controls, to measure circadian clock gene expression in peripheral blood mononuclear cells. Participants are assessed at baseline and at 1, 3, and 6 months, with treatment decisions for Cushing's syndrome tailored to circadian rhythms. The primary outcome compares CLOCK and ARNTL gene expression between patients and controls, while secondary outcomes assess circadian gene expression timing relative to healthy controls. The study evaluates how endogenous glucocorticoid dysregulation and treatment may influence circadian biology. Eligibility includes adults with adrenal disorders or active Cushing's syndrome, with various exclusions to minimize risk and confounding factors.

Why it matters

Who can join: the full rules

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); (except for the exogenous glucocorticoid cohort)
* alcoholism and/or drug addictions;
* night-shift workers;
* 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.

Where it's running

• Department of Experimental Medicine, "Sapienza" University of Rome
  Roma, Roma, Italy Recruiting

Study contacts

• Study coordinator: Andrea Isidori, MD,PhD
• Email: andrea.isidori@uniroma1.it
• Phone: 0039649970711

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.