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

Официальное название

A Single Center, Prospective, Observational Study to Explore and Evaluate the Differences of Cognitive Function and Brain Function Between Non-functioning Adrenal Adenomas and Autonomous Cortisol Secretion Patients, and the Different Treatments Methods on Cognitive Function and Brain Function in Patients With Autonomous Cortisol Secretion

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое Cognitive function assessment; functional magnetic resonance imaging
  cognitive function measurement
• Процедура laparoscopic adrenal surgery
  Only a subgroup of the autonomous cortisol secretion patients will have the laparoscopic adrenal surgery

Первичные конечные точки

• Participants' personal information [Срок оценки: 1 day]
• Physical assessments [Срок оценки: 1 day]
• Imaging examinations [Срок оценки: 1 day]
• Montreal Cognitive Assessment (MoCA) [Срок оценки: 20 minutes]
• Mini-Mental State Examination (MMSE) [Срок оценки: 20 minutes]
• Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [Срок оценки: 1 hour]
• Rest Functional MRI of the brain function. [Срок оценки: 40 minutes]
• Screening for adrenal cortisol hypersecretion [Срок оценки: 1 day]

Вторичные конечные точки (6)

• Changes from basline global cognitive functions [Срок оценки: 12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]]
• Changes from basline multiple cognitive subdomains [Срок оценки: 12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]]
• Change from baseline Functional magnetic resonance imagine [Срок оценки: 12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]]
• Changes from basline global cognitive functions [Срок оценки: 12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)]]
• Changes from basline multiple cognitive subdomains [Срок оценки: 12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)]]
• Change from baseline Functional magnetic resonance imagine [Срок оценки: 12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)]]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• < 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical — Нанкин

Публикации

• Liu MS, Tian ZY, Zhang Z, Yang F, Lou Y, Wang YJ, Zeng YJ, Zhang ZW, Zhu DL, Li P. Impaired Cognitive Function in Patients With Autonomous Cortisol Secretion in Adrenal Incidentalomas. J Clin Endocrinol Metab. 2023 Feb 15;108(3):633-641. doi: 10.1210/clinem/dgac603. PMID 36263685

Идентификаторы

NCT: NCT05357456 · LP2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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