An observational study in Autonomous Cortisol Secretion, Adrenal Incidentaloma and Non-functioning Adrenal Adenomas, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Recruiting at 1 site in China. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-02.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Observational
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.
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's planned enrollment of 62 is below the median of 300 across 226 observational studies indexed under Adenoma.
Browse Adenoma studies →The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.
Counted across the registry records on this site, refreshed daily.
autonomous cortisol secretion and non-functioning adrenal adenomas patients
Exclusion Criteria:
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
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
cognitive function measurement
Also known as: fMRI
Only a subgroup of the autonomous cortisol secretion patients will have the laparoscopic adrenal surgery
Participants' personal information
Self-reported information(education in years)
Time frame: 1 day
Physical assessments
BMI(body mess index) in kg/m\^2
Time frame: 1 day
Imaging examinations
Adrenal adenoma size in cm
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 1 hour
Rest Functional MRI of the brain function.
Rs-fMRI
Time frame: 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
Time frame: 1 day
Changes from basline global cognitive functions
MoCA
Time frame: 12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]
Changes from basline multiple cognitive subdomains
RBANS
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)]
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School