Evaluating cognitive and brain function in patients with autonomous cortisol secretion
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
This study is trying to see how autonomous cortisol secretion affects thinking and brain function in patients with certain adrenal tumors before and after they receive different treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 62 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05357456 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess cognitive and brain function in patients with autonomous cortisol secretion using functional MRI. It will explore the differences in cognitive performance and brain activity before and after various treatment methods, including laparoscopic adrenal surgery. The study focuses on patients with adrenal incidentalomas and non-functioning adrenal adenomas, aiming to fill the gap in understanding how autonomous cortisol secretion affects cognitive health. By analyzing these factors, the study seeks to provide insights into the neurocognitive impacts of cortisol dysregulation.
Who should consider this trial
Good fit: Ideal candidates are right-handed adults aged 20-65 with adrenal lesions of at least 1 cm and a history of autonomous cortisol secretion or non-functioning adrenal adenomas.
Not a fit: Patients with active malignancies, central nervous system diseases, or contraindications for MRI are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cognitive impairments associated with autonomous cortisol secretion.
How similar studies have performed: While there is limited data on the cognitive effects of autonomous cortisol secretion, previous studies have shown cognitive impairments in Cushing's syndrome, suggesting potential relevance for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nanjing, Jiangsu
- Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Dalong Zhu, MD,PhD — The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study coordinator: Dalong Zhu, MD,PhD
- Email: zhudalong@nju.edu.cn
- Phone: 86-25-83-105302
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.