Performances on Cognitive Functions and Brain Function and Follow-up After Different Treatments in Patients With Autonomous Cortisol Secretion: a Single-center, Prospective, Observational Study

Nanjing University

Status: Enrolling

Conditions: Autonomous Cortisol Secretion; Non-functioning Adrenal Adenomas; Adrenal Incidentaloma

Treatments: Procedure: laparoscopic adrenal surgery; Behavioral: Cognitive function assessment; functional magnetic resonance imaging

Study type: Observational

Funder types: Other

Identifiers

NCT05357456

LP2022

Details and patient eligibility

About

This is a single center, prospective, observational study to explore and evaluate the differences on cognitive function and brain function by functional-MRI in autonomous cortisol secretion patients, and the different treatments methods on the cognitive function and brain function in patients with autonomous cortisol secretion

Full description

Glucocorticoids, mainly cortisol, play a crucial role in the allostatic process of adjustment to stressors and can determine important changes in central nervous system structures. It is well known that Cushing's syndrome (CS) is associated with neurocognitive impairment in about two-thirds of cases. In CS the most frequent reported alterations are memory impairment (about 83% of cases) and reduced concentration (66% of cases) . Unfortunately, these alterations are only partially reversible after the hypercortisolism resolution. As so far, data related to the impact of autonomous cortisol secretion (ACS) on cognitive function are scarce and lack of magnetic resonance indicators. Few studies have studied the cognitive function changes of patients with ACS by surgical and conservative treatment. In the single center, prospective and observational study we aim to explore cognitive functions and brain function by functional-MRI in adrenal incidentaloma patients in relation to the presence of ACS and, secondly, in a group of acs patients, the effect of adrenalectomy on cognitive functions and brain function.

Enrollment: 62 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 20-65 years;
• ≥ 6 years of education；
• right-handed;
• complete entire cognitive function tests;
• adrenal lesions ≥ 1 cm in diameter;
• patients with non-functioning adrenal adenomas;
• patients with autonomous cortisol secretion.

Exclusion criteria

• < 6 years of education;
• age < 20 years or > 65 years;
• maximum diameter of AI <1cm;
• active malignancies;
• with a history of thyroid disease;
• with a history of acute infection in the last month;
• central nervous system diseases, including brain trauma, intracranial hemorrhage, acute cerebral infarction, etc;
• contraindications of MRI examination: such as implantation of metal prosthesis in vivo, claustrophobia, etc;
• adrenal tuberculosis;
• suspected or diagnosed adrenocortical carcinoma;
• unable to complete entire cognitive function tests;
• current use of steroids or any drugs known to alter steroid synthesis or metabolism in the previous 3 months;
• clinical Cushing syndrome;
• Cushing disease;
• primary hyperaldosteronism;
• pheochromocytoma;
• severe impairment of heart, liver, kidney and other organs;
• pregnant and lactating women

Trial design

62 participants in 2 patient groups

autonomous cortisol secretion

Description:

Patients admitted to the hospital with adrenal incidentalomas are evaluated for adrenal function, and then ACS patients are diagnosed based on the serum cortisol ≥ 50 nmol/L following the 1 mg dexamethasone suppression test and without any other signs or symptoms of cortisol excess.Patients with ACS will undergo a physical exam, cognitive function test as well as structural and functional brain MRI at baseline and 12 months after their surgery or conservative treatment.

Treatment:

Behavioral: Cognitive function assessment; functional magnetic resonance imaging

Procedure: laparoscopic adrenal surgery

non-functioning adrenal adenomas

Description:

Patients admitted to the hospital with adrenal incidentalomas are evaluated for adrenal function, and then non-functioning adrenal adenomas patients are diagnosed based on the serum cortisol \< 50 nmol/L following the 1 mg dexamethasone suppression test .Patients with non-functioning adrenal adenomas will undergo a physical exam, cognitive function test as well as structural and functional brain MRI at baseline.

Treatment:

Behavioral: Cognitive function assessment; functional magnetic resonance imaging