Status:
RECRUITING
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
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Autonomous Cortisol Secretion
Adrenal Incidentaloma
Eligibility:
All Genders
20-65 years
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, ...
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 th...
Eligibility Criteria
Inclusion
- 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
- \< 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
Key Trial Info
Start Date :
October 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT05357456
Start Date
October 1 2021
End Date
October 1 2026
Last Update
May 2 2022
Active Locations (1)
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1
Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School
Nanjing, Jiangsu, China, 210008