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
- Conditions
- Autonomous Cortisol SecretionNon-functioning Adrenal AdenomasAdrenal Incidentaloma
- Interventions
- Behavioral: Cognitive function assessment; functional magnetic resonance imagingProcedure: laparoscopic adrenal surgery
- Registration Number
- NCT05357456
- Lead Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- 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
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 62
- 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.
- < 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description autonomous cortisol secretion Cognitive function assessment; functional magnetic resonance imaging 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 Cognitive function assessment; functional magnetic resonance imaging 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. autonomous cortisol secretion laparoscopic adrenal surgery 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.
- Primary Outcome Measures
Name Time Method Participants' personal information 1 day Self-reported information(education in years)
Screening for adrenal cortisol hypersecretion 1 day Patients were given 1 mg dexamethasone orally at 24:00 am, and the cortisol levels were measured at 8:00 am the following morning
Mini-Mental State Examination (MMSE) 20 minutes The MMSE is a cognitive screening test designed to assist Health Professionals in detection of mild cognitive impairment.
Rest Functional MRI of the brain function. 40 minutes Rs-fMRI
Physical assessments 1 day BMI(body mess index) in kg/m\^2
Montreal Cognitive Assessment (MoCA) 20 minutes The MoCA is a Global cognitive screening test designed to assist Health Professionals in detection of mild cognitive impairment.
Imaging examinations 1 day Adrenal adenoma size in cm
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) 1 hour The RBANS is a cognitive screening test designed to assist Health Professionals in evaluation of multiple cognitive subdomains
- Secondary Outcome Measures
Name Time Method Change from baseline Functional magnetic resonance imagine 12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)] Rs-fMRI
Changes from basline global cognitive functions 12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)] MoCA
Changes from basline multiple cognitive subdomains 12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)] RBANS
Trial Locations
- Locations (1)
Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China