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

Adrenal Incidentaloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05357456
• Other study ID #: LP2022
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: October 1, 2026

Study information

• Verified date: April 2022
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Dalong Zhu, MD,PhD
• Phone: 86-25-83-105302
• Email: zhudalong[@]nju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adrenal Incidentaloma
• Adrenocortical Adenoma

Intervention

Behavioral:
• Cognitive function assessment; functional magnetic resonance imaging
cognitive function measurement

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

Locations

Country	Name	City	State
China	Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants' personal information	Self-reported information(education in years)	1 day
Primary	Physical assessments	BMI(body mess index) in kg/m^2	1 day
Primary	Imaging examinations	Adrenal adenoma size in cm	1 day
Primary	Montreal Cognitive Assessment (MoCA)	The MoCA is a Global cognitive screening test designed to assist Health Professionals in detection of mild cognitive impairment.	20 minutes
Primary	Mini-Mental State Examination (MMSE)	The MMSE is a cognitive screening test designed to assist Health Professionals in detection of mild cognitive impairment.	20 minutes
Primary	Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	The RBANS is a cognitive screening test designed to assist Health Professionals in evaluation of multiple cognitive subdomains	1 hour
Primary	Rest Functional MRI of the brain function.	Rs-fMRI	40 minutes
Primary	Screening for adrenal cortisol hypersecretion	Patients were given 1 mg dexamethasone orally at 24:00 am, and the cortisol levels were measured at 8:00 am the following morning	1 day
Secondary	Changes from basline global cognitive functions	MoCA	12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]
Secondary	Changes from basline multiple cognitive subdomains	RBANS	12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]
Secondary	Change from baseline Functional magnetic resonance imagine	Rs-fMRI	12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]
Secondary	Changes from basline global cognitive functions	MoCA	12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)]
Secondary	Changes from basline multiple cognitive subdomains	RBANS	12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)]
Secondary	Change from baseline Functional magnetic resonance imagine	Rs-fMRI	12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)]