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

NCT05357456 | Recruiting

• 1 other identifier: LP2022
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

cognitive function; functional MRI; treatment

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• Changes from basline global cognitive functions

  12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]

• Changes from basline multiple cognitive subdomains

  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

  12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]

• Changes from basline global cognitive functions

  12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)]

• Changes from basline multiple cognitive subdomains

  12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)]

Study Arms (2)

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; Procedure: 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

Interventions

Cognitive function assessment; functional magnetic resonance imaging BEHAVIORAL

cognitive function measurement

Also known as: fMRI

autonomous cortisol secretion; non-functioning adrenal adenomas

laparoscopic adrenal surgery PROCEDURE

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

autonomous cortisol secretion

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

autonomous cortisol secretion and non-functioning adrenal adenomas patients

You may qualify if:

• 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.

You may not qualify if:

• \< 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;

Sponsors & Collaborators

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

Study Sites (1)

Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Adrenal incidentaloma

Study Officials

• Dalong Zhu, MD,PhD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dalong Zhu, MD,PhD

CONTACT

86-25-83-105302; zhudalong@nju.edu.cn

PIng Li, MD,PhD

CONTACT

86-25-83-105302; li78321@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 2, 2022
• Study Start: October 1, 2021
• Primary Completion: October 1, 2024
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

CN (1)