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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive function assessment; functional magnetic resonance imaging | Behavioral | cognitive function measurement |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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autonomous cortisol secretion and non-functioning adrenal adenomas patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Dalong Zhu, MD,PhD | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School | Recruiting | Nanjing | Jiangsu | 210008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36263685 | Derived | 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. |
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|
| laparoscopic adrenal surgery | Procedure | Only a subgroup of the autonomous cortisol secretion patients will have the laparoscopic adrenal surgery |
|
| 1 day |
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)] |
| ID | Term |
|---|---|
| C538238 | Adrenal incidentaloma |
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