Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations
Key facts
- Who runs it
- University of Roma La Sapienza
- Where
- Rome, ItalySee the site
- Trial code
- Status
- Recruiting
- People taking part
- 68 people, planned
- Started
- 2 Jan 2019
- Planned end
- 31 Dec 2025
- Type of study
- Observational, 4 groups
- Treatments tested
- Adrenalectomy
- Record updated
- 28 March 2025
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- Incidentally detected adrenal mass
Who cannot take part
- Patients taking medications influencing glucocorticoid production or metabolism
- Patients with overt Cushing's syndrome, pheochromocytoma, Conn syndrome, adrenocortical carcinoma, late-onset congenital adrenal hyperplasia, adrenal metastasis and adrenal hemorrhage
- Patients with psychiatric diseases or alcohol abuse
- Pregnancy
Check if you might fit
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?
Where in Italy
- Department of Experimental MedicineRome, ItalyContact: Andrea M Isidori, MD, PhDTaking people
About the trial
What the trial wants to find out
The investigators hypothesize that cardiovascular and metabolic alterations can occur in patients with adrenal adenomas and possible Autonomous Cortisol Secretion (pACS). Investigators hypothesize that adrenalectomy in selected patients, following the 2016 European Congress of Endocrinology (ECE) guidelines, can improve metabolic parameters and cardiovascular risks and features.
The 4 groups in the trial
- Patients with non-functioning adrenal adenoma
Patients with incidentally discovered adrenal mass with 1mg-DST serum cortisol levels lower than 50 nmol/L
- Patients with pACS receiving conservative management
Patients with incidentally discovered adrenal mass with 1mg-DST serum cortisol levels greater than 50 nmol/L receiving conservative management
- Patients with pACS receiving adrenalectomy
Patients with incidentally discovered adrenal mass with 1mg-DST serum cortisol levels greater than 50 nmol/L receiving adrenalectomy according to the 2016 European Society of Endocrinology guidelines
Treatment: Adrenalectomy
- Healthy controls
Patients without adrenal masses
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations (ITACA Study)
- Fit questions
- Built from NCT04127552, who can take part
- Record updated
- 28 March 2025