Adrenal Incidentaloma Clinical Trial
Official title:
A Single Center, Prospective, Observational Study to Explore and Evaluate the Differences of Cognitive Function and Brain Function Between Non-functioning Adrenal Adenomas and Autonomous Cortisol Secretion Patients, and the Different Treatments Methods on Cognitive Function and Brain Function in Patients With Autonomous Cortisol Secretion
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 |
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
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 |
Country | Name | City | State |
---|---|---|---|
China | Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
China,
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)] |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04860180 -
Effect of Surgical or Conservative Approach in Patients With Adrenal Incidentalomas
|
N/A | |
Completed |
NCT03919734 -
Morbidity and Mortality in Autonomous Cortisol Secretion
|
||
Enrolling by invitation |
NCT03474237 -
A Prospective Cohort Study for Patients With Adrenal Diseases
|
||
Completed |
NCT04682938 -
The Prevalence and Characteristics of Adrenal Incidentaloma
|
||
Recruiting |
NCT04890444 -
China Adrenal Disease Registry
|
||
Recruiting |
NCT04616703 -
Natural History of NFAI: 10 Year Follow-up Results
|
||
Recruiting |
NCT04328181 -
Comparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT)
|
N/A | |
Recruiting |
NCT02324647 -
Structured Evaluation of adRENal Tumors Discovered Incidentally - Prospectively Investigating the Testing Yield
|
||
Recruiting |
NCT04127552 -
Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations
|
||
Active, not recruiting |
NCT04917757 -
Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas
|
||
Completed |
NCT01949714 -
Effect of Chronic Catecholamine Overproduction on Brown Adipose Tissue
|
||
Recruiting |
NCT05237817 -
Association Between Stroke and Adrenal Incidentalomas
|
||
Recruiting |
NCT04833192 -
Evaluation of New Diagnostic Indicator of Subclinical Hypercortisolism
|