Long-term cardiac effects of adrenalectomy versus surveillance in mild cortisol excess: 5-year results from the prospective ITACA study.
Dario De Alcubierre, Davide Ferrari, Alessandra Tomaselli...
https://pubmed.ncbi.nlm.nih.gov/41572809Actively Recruiting
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID04127552
Impact of Adrenal Incidentalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations (ITACA Study)
Led by University of Roma La Sapienza · Updated on 2025-03-28
68
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating the effects of adrenal incidentalomas and possible autonomous cortisol secretion (pACS) on cardiovascular and metabolic health. The study focuses on patients with adrenal masses that may partially alter cortisol levels without clear symptoms of cortisol excess. It aims to understand how these conditions impact heart and metabolic functions and whether surgery or conservative management can improve patient outcomes. Participants include those with different adrenal conditions: non-functioning adrenal adenomas, pACS managed conservatively, pACS treated with adrenalectomy following 2016 European Society of Endocrinology guidelines, and healthy individuals without adrenal masses. The study follows these groups over time to compare the effects of surgical and non-surgical approaches on health markers. Participants will undergo assessments at the start, one year, and five years later. These include heart ultrasound to check for left ventricular hypertrophy, blood pressure and arterial stiffness measurements, blood tests for coagulation and lipid profiles, bone density scans, and questionnaires evaluating sleep, infections, quality of life, depression, and sexual function. Researchers will monitor changes in insulin resistance, weight, and adrenal mass size throughout the study to better understand the cardiovascular and metabolic changes associated with these adrenal conditions.
CONDITIONS
Brief Title
Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations
Who Can Participate
Age: 18Years - 80Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Incidentally detected adrenal mass
- Age between 18 and 80 years
You will not qualify if you...
- Overt Cushing's syndrome, pheochromocytoma, Conn syndrome, adrenocortical carcinoma, late-onset congenital adrenal hyperplasia, adrenal metastasis, or adrenal hemorrhage
- Taking medications that influence glucocorticoid production or metabolism
- Psychiatric diseases or alcohol abuse
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Baseline assessments on a single occasion
Participants undergo baseline assessments including blood tests, imaging of the adrenal mass, questionnaires, and other cardiovascular and metabolic measurements.
1 visit (in-person)
Long-term Monitoring
Duration - 5 years
Participants are followed longitudinally with assessments at 1 year and 5 years to evaluate cardiovascular and metabolic changes depending on their group assignment and management strategy.
2 visits (in-person) at 1 year and 5 years
Trial Site Locations
Total: 1 location
1
Department of Experimental Medicine
Rome, Italy, Italy, 00161
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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