Clinical trial NCT05357456: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autonomous Cortisol Secretion
Adrenal Incidentaloma
Non-functioning Adrenal Adenomas
Keywords: cognitive function
functional MRI
treatment
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: autonomous cortisol secretion and non-functioning adrenal adenomas patients

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Participants' personal information
timeFrame: 1 day
measure: Physical assessments
timeFrame: 1 day
measure: Imaging examinations
timeFrame: 1 day
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 20 minutes
measure: Mini-Mental State Examination (MMSE)
timeFrame: 20 minutes
measure: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: 1 hour
measure: Rest Functional MRI of the brain function.
timeFrame: 40 minutes
measure: Screening for adrenal cortisol hypersecretion
timeFrame: 1 day
Secondary outcomes:
measure: Changes from basline global cognitive functions
timeFrame: 12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]
measure: Changes from basline multiple cognitive subdomains
timeFrame: 12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]
measure: Change from baseline Functional magnetic resonance imagine
timeFrame: 12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]
measure: Changes from basline global cognitive functions
timeFrame: 12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)]
measure: Changes from basline multiple cognitive subdomains
timeFrame: 12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)]
measure: Change from baseline Functional magnetic resonance imagine
timeFrame: 12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)]
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Dalong Zhu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: