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

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

Study Overview

• Status: Recruiting
• Conditions: Adrenal Incidentaloma; Autonomous Cortisol Secretion; Non-functioning Adrenal Adenomas
• Intervention / Treatment: Behavioral: Cognitive function assessment; functional magnetic resonance imaging; Procedure: laparoscopic adrenal surgery

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.

• Study Type: Observational
• Enrollment (Anticipated): 62

Contacts and Locations

• Study Contact: Name: Dalong Zhu, MD,PhD; Phone Number: 86-25-83-105302; Email: zhudalong@nju.edu.cn
• Study Contact Backup: Name: Ping Li, MD,PhD; Phone Number: 86-25-83-105302; Email: li78321@yeah.net

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School
      • Contact: Dalong Zhu, MD,PhD; Phone Number: 86-25-83-105302; Email: zhudalong@nju.edu.cn
      • Contact: Ping Li, MD,PhD; Phone Number: 86-25-83-105302; Email: li78321@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

autonomous cortisol secretion and non-functioning adrenal adenomas patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
autonomous cortisol secretion; 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.	Behavioral: Cognitive function assessment; functional magnetic resonance imaging; cognitive function measurement; Other Names: fMRI; Procedure: laparoscopic adrenal surgery; Only a subgroup of the autonomous cortisol secretion patients will have the laparoscopic adrenal surgery
non-functioning adrenal adenomas; 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.	Behavioral: Cognitive function assessment; functional magnetic resonance imaging; cognitive function measurement; Other Names: fMRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants' personal information	Self-reported information(education in years)	1 day
Physical assessments	BMI(body mess index) in kg/m^2	1 day
Imaging examinations	Adrenal adenoma size in cm	1 day
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
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
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
Rest Functional MRI of the brain function.	Rs-fMRI	40 minutes
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)]
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)]
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)]
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)]
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)]
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)]

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2021
• Primary Completion (ANTICIPATED): October 1, 2024
• Study Completion (ANTICIPATED): October 1, 2026

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (ACTUAL): May 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: treatment; cognitive function; functional MRI
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Adrenal Gland Diseases; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Adrenal Cortex Diseases; Adenoma; Adrenocortical Adenoma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: LP2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No