Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of Roma La Sapienza

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Incidentally detected adrenal mass

Disqualifiers

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

Trial population

Patients with non-functioning adrenal incidentalomas or adrenal incidentalomas associated with possible autonomous cortisol secretion (subclinical hypercortisolism)

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Adrenalectomy

    Procedure/Surgery

    Adrenalectomy according to 2016 ESE guidelines

Treatment groups

68 Participants
are divided into 4 treatment groups
Group A: Patients with non-functioning adrenal adenoma0 interventions
Group B: Patients with pACS receiving conservative management0 interventions
Group C: Patients with pACS receiving adrenalectomy1 intervention
Group D: Healthy controls0 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

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