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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	20 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05357456
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Dalong Zhu, MD,PhD
Principal Investigator Affiliation	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Autonomous Cortisol Secretion, Adrenal Incidentaloma, Non-functioning Adrenal Adenomas

Additional Details

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.

Arms & Interventions

Arms

: 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.

: 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.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Nanjing, Jiangsu, China

Status

Recruiting

Address

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

Nanjing, Jiangsu, 210008

Site Contact

Dalong Zhu, MD,PhD

[email protected]

86-25-83-105302

Clinical Trial Finder