An observational study in Adrenal Incidentaloma, Hypercortisolism and Adrenal Tumor, sponsored by University of Roma La Sapienza. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by University of Roma La Sapienza · Observational
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.
Adrenal incidentalomas are clinically silent masses discovered inadvertently during diagnostic imaging procedures performed for unrelated reasons. Depending on the criteria applied, up to 50% of patients with adrenal incidentalomas may have biochemical evidence of cortisol excess. Possible autonomous cortisol secretion (pACS), as defined in the 2016 European Society of Endocrinology Guidelines, is characterized by a partial, incomplete suppression of the hypothalamic-pituitary-adrenal (HPA) axis without the typical signs of overt cortisol hypersecretion.
Investigators will perform a prospective longitudinal study in patients with adrenal incidentalomas associated with possible autonomous cortisol secretion, aiming to assess the effect of surgical and conservative management on cardiovascular and metabolic features.
Data will be detected at baseline, at 1 and at 5 years follow-up to quantitatively identify the different cardiovascular and metabolic alterations in: (1) patients with non-functioning adrenal adenoma; (2) patients with possible autonomous cortisol secretion receiving conservative management; (3) patients with possible autonomous cortisol secretion receiving adrenalectomy according to the 2016 European Society of Endocrinology guidelines; (4) patients without adrenal masses.
27 studies on the registry are indexed under Adrenal incidentaloma; 12 are open to participants now.
This study's planned enrollment of 68 is below the median of 300 across 18 observational studies indexed under Adrenal incidentaloma.
Browse Adrenal incidentaloma studies →University of Roma La Sapienza is the lead sponsor of 398 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with non-functioning adrenal incidentalomas or adrenal incidentalomas associated with possible autonomous cortisol secretion (subclinical hypercortisolism)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with incidentally discovered adrenal mass with 1mg-DST serum cortisol levels lower than 50 nmol/L
Patients with incidentally discovered adrenal mass with 1mg-DST serum cortisol levels greater than 50 nmol/L receiving conservative management
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
Procedure: Adrenalectomy
Patients without adrenal masses
Adrenalectomy according to 2016 ESE guidelines
Echocardiographic Change of Left Ventricular Hypertrophy
Change of Left Ventricular Hypertrophy will be evaluated by transthoracic echocardiography. Patients will be examined in the left lateral decubitus position according to the American Society of Echocardiography guidelines.
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Change of arterial stiffness and blood pressure using brachial oscillometric blood pressure waves for a noninvasive estimation.
Perform non-invasive measurement of arterial stiffness
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Change of blood pressure using ambulatory blood pressure monitoring blood pressure waves for a noninvasive estimation.
Perform twenty-four-hour systolic and diastolic ambulatory blood pressure monitoring
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Change in blood Coagulation Tests
Perform blood sampling for coagulative function
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Change in Dual X-Ray Absorptiometry T-score
Bone mineral density change in spine and femur
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Radiological evaluation of adrenal mass
Perform adrenal chemical shift MRI or adrenal CT scan (if MRI is contraindicated)
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Evaluation of sleep disturbances using questionnaire (PSQI)
Perform the Pittsburgh Sleep Quality Index (PSQI). Sleep disturbances will be evaluated by The Pittsburgh Sleep Quality Index (PSQI). This questionnaire contains 19 self-related questions which are combined to create 7 component scores with a range of 0-3 points (0:no difficulty, 3: severe difficulty). Global score is the result to the addition of all component scores with a range of 0-21 points (0:no difficulty, 21: severe difficulty).
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Infectious diseases frequency and severity with modified German Diseases Questionnaire
Frequencies and severity of infectious diseases will be evaluated by modified Infectious Diseases Questionnaire (GNC). This questionnaire includes questions on infectious diseases of upper and lower respiratory tract, gastrointestinal tract, skin and urogenital tract and flu contracted during the previous 12 months. Questions investigate on the number and duration of infections, necessity of antibiotic or antifungal therapy, hospital stay and days of absence from work. Final score represents the frequency of infections.
Time frame: Baseline (T0), after 1 year (t1) and 5 years (t2)
Quality of life: SF-36-Item Health Survey questionnaire
Quality of life will be evaluated by the Physical Component score and the Mental Component score of the self-administered questionnaire SF-36-Item Health Survey questionnaire. This questionnaire measures eight scales: physical functioning, role physical, bodily pain, general health (physical component) and vitality, social functioning, role emotional, mental health (mental component). Interpretation of the score will be the following: at each item of the questionnaire corresponds a percentage value (from 0% to 100%). The average of the single items constitutes the scale total percentage (from 0% to 100%); missing data are not considered during calculation. High score defines a more favorable health state.
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Psychometric Evaluation: Beck Depression Inventory questionnaire
Psychometric evaluation will be assessed by the score of Beck depression Index: a 21-item measure of depressive symptoms. Each answer is scored on a scale value (from 0 to 3 points). The global score is obtained adding all single scores, with a range of 0-63. Higher score constitutes worse burden of symptoms (0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, 29-63: severe depression).
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Evaluation of sexual dysfunction using FSFI questionnaire in woman
Perform the Female Sexual Function Index (FSFI) questionnaire. This is a 19-item questionnaire that covers six domains: desire, arousal, lubrication, and orgasm, satisfaction, and pain. The ranges of the domain scores are as follows: for desire 1.2 - 6.0, for arousal, lubrication, orgasm and pain 0 - 6.0 and for satisfaction 0.8 - 6.0. The higher scores of the six domains indicate better sexual functioning about that domain. The overall FSFI score is obtained by summing the six domain scores. The overall FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Evaluation of sexual dysfunction using IIEF questionnaire in man
Perform the International Index of Erectile Function (IIEF) questionnaire in man. The IIEF is an internationally validated test. It is used to assign a score of erectile dysfunction: severe score 1 to 10; moderate score 11 to 16; low to moderate score 17 to 21; Low score 22 to 25; no erectile dysfunction score 26 to 30
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Change in insulin resistance calculated with HOMA index
Measurement of HOMA index calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Change in measurement of weight
Measurement of body weight (kg)
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Change in blood lipid profile
Measurement of Total Cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2019 (actual). Primary completion is estimated for Dec 2025, 83 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Roma La Sapienza →