Clinical trial NCT04127552: Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations
Official title: Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations (ITACA Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adrenal Incidentaloma
Hypercortisolism
Adrenal Tumor
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-functioning adrenal incidentalomas or adrenal incidentalomas associated with possible autonomous cortisol secretion (subclinical hypercortisolism)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Incidentally detected adrenal mass

Exclusion Criteria:

* Patients with overt Cushing's syndrome, pheochromocytoma, Conn syndrome, adrenocortical carcinoma, late-onset congenital adrenal hyperplasia, adrenal metastasis and adrenal hemorrhage
* Patients taking medications influencing glucocorticoid production or metabolism
* Patients with psychiatric diseases or alcohol abuse
* Pregnancy

Primary outcomes:
measure: Echocardiographic Change of Left Ventricular Hypertrophy
timeFrame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Secondary outcomes:
measure: Change of arterial stiffness and blood pressure using brachial oscillometric blood pressure waves for a noninvasive estimation.
timeFrame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
measure: Change of blood pressure using ambulatory blood pressure monitoring blood pressure waves for a noninvasive estimation.
timeFrame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
measure: Change in blood Coagulation Tests
timeFrame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
measure: Change in Dual X-Ray Absorptiometry T-score
timeFrame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
measure: Radiological evaluation of adrenal mass
timeFrame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
measure: Evaluation of sleep disturbances using questionnaire (PSQI)
timeFrame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
measure: Infectious diseases frequency and severity with modified German Diseases Questionnaire
timeFrame: Baseline (T0), after 1 year (t1) and 5 years (t2)
measure: Quality of life: SF-36-Item Health Survey questionnaire
timeFrame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
measure: Psychometric Evaluation: Beck Depression Inventory questionnaire
timeFrame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
measure: Evaluation of sexual dysfunction using FSFI questionnaire in woman
timeFrame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
measure: Evaluation of sexual dysfunction using IIEF questionnaire in man
timeFrame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
measure: Change in insulin resistance calculated with HOMA index
timeFrame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
measure: Change in measurement of weight
timeFrame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
measure: Change in blood lipid profile
timeFrame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Experimental Medicine
Study officials:
affiliation: Sapienza
name: Andrea M Isidori, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: