Impaired Cognitive Function in Patients With Autonomous Cortisol Secretion in Adrenal Incidentalomas.
Meng-Si Liu, Zhao-Yang Tian, Zhou Zhang...
https://pubmed.ncbi.nlm.nih.gov/36263685Actively Recruiting
Age: 20Years - 65Years
All Genders
Healthy Volunteers
ID05357456
A Single Center, Prospective, Observational Study to Explore and Evaluate Cognitive and Brain Function Differences in Patients With Autonomous Cortisol Secretion and Non-functioning Adrenal Adenomas, Including Treatment Effects on Autonomous Cortisol Secretion
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2022-05-02
62
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a single-center, prospective, observational study to explore how cognitive function and brain function differ between patients with autonomous cortisol secretion (ACS) and those with non-functioning adrenal adenomas. The study also evaluates how different treatments affect cognitive and brain function in patients with ACS. This research addresses a gap in understanding the impact of ACS on cognition and brain activity, using functional MRI as an important tool. Patients admitted with adrenal incidentalomas undergo evaluation for adrenal function to determine whether they have ACS or non-functioning adrenal adenomas based on serum cortisol levels after a dexamethasone suppression test. Those diagnosed with ACS will receive either laparoscopic adrenal surgery or conservative treatment. Both ACS patients and those with non-functioning adrenal adenomas will have physical exams, cognitive function tests, and brain MRI scans. ACS patients will be assessed at baseline and again 12 months after their treatment, while non-functioning adenoma patients will be assessed at baseline only. Participants will undergo multiple assessments including cognitive tests like the Montreal Cognitive Assessment (MoCA), Mini-Mental State Examination (MMSE), and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Brain function will be evaluated via resting functional MRI. Researchers will collect personal and physical data, screen adrenal cortisol secretion, and monitor changes in cognitive function and brain imaging over 12 months after treatment for ACS patients. The study aims to understand cognitive and brain changes related to ACS and the effects of treatment over time.
CONDITIONS
Brief Title
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
Who Can Participate
Age: 20Years - 65Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age between 20 and 65 years
- At least 6 years of education
- Right-handed
- Able to complete all cognitive function tests
- Have adrenal lesions 1 cm or larger in diameter
- Diagnosed with non-functioning adrenal adenomas or autonomous cortisol secretion
You will not qualify if you...
- Less than 6 years of education
- Younger than 20 years or older than 65 years
- Adrenal incidentaloma smaller than 1 cm
- Active malignancies
- History of thyroid disease
- Recent acute infection within the last month
- Central nervous system diseases such as brain trauma, intracranial hemorrhage, or acute cerebral infarction
- Contraindications to MRI, including metal implants or claustrophobia
- Adrenal tuberculosis
- Suspected or diagnosed adrenocortical carcinoma
- Unable to complete all cognitive function tests
- Use of steroids or drugs affecting steroid metabolism in the past 3 months
- Clinical Cushing syndrome
- Cushing disease
- Primary hyperaldosteronism
- Pheochromocytoma
- Severe heart, liver, kidney, or other organ impairment
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants undergo cognitive function tests and structural and functional brain MRI to assess cognitive and brain function at baseline.
1 visit (in-person)
Long-term Monitoring
Duration - 12 months
Participants with autonomous cortisol secretion are followed for 12 months after either laparoscopic adrenal surgery or conservative treatment to observe changes in cognitive functions and brain function.
1 visit at 12 months (in-person)
Trial Site Locations
Total: 1 location
1
Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Actively Recruiting
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Research Team
D
Dalong Zhu, MD,PhD
P
PIng Li, MD,PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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