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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05357456
Other study ID # LP2022
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)]
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