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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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05357456
Enrollment
62
Registered
2022-05-02
Start date
2021-10-01
Completion date
2026-10-01
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Incidentaloma, Autonomous Cortisol Secretion, Non-functioning Adrenal Adenomas

Keywords

cognitive function, functional MRI, treatment

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.

Interventions

BEHAVIORALCognitive function assessment; functional magnetic resonance imaging

cognitive function measurement

PROCEDURElaparoscopic adrenal surgery

Only a subgroup of the autonomous cortisol secretion patients will have the laparoscopic adrenal surgery

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Screening for adrenal cortisol hypersecretion1 dayPatients were given 1 mg dexamethasone orally at 24:00 am, and the cortisol levels were measured at 8:00 am the following morning
Mini-Mental State Examination (MMSE)20 minutesThe MMSE is a cognitive screening test designed to assist Health Professionals in detection of mild cognitive impairment.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)1 hourThe RBANS is a cognitive screening test designed to assist Health Professionals in evaluation of multiple cognitive subdomains
Rest Functional MRI of the brain function.40 minutesRs-fMRI
Participants' personal information1 daySelf-reported information(education in years)
Physical assessments1 dayBMI(body mess index) in kg/m\^2
Imaging examinations1 dayAdrenal adenoma size in cm
Montreal Cognitive Assessment (MoCA)20 minutesThe MoCA is a Global cognitive screening test designed to assist Health Professionals in detection of mild cognitive impairment.

Secondary

MeasureTime frameDescription
Changes from basline global cognitive functions12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]MoCA
Changes from basline multiple cognitive subdomains12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]RBANS
Change from baseline Functional magnetic resonance imagine12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]Rs-fMRI

Countries

China

Contacts

Primary ContactDalong Zhu, MD,PhD
zhudalong@nju.edu.cn86-25-83-105302
Backup ContactPIng Li, MD,PhD
li78321@yeah.net86-25-83-105302

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026