NCT05357456

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 62 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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, and the different treatments methods on the cognitive function and brain function in patients with autonomous cortisol secretion

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 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.

Conditions

• Autonomous Cortisol Secretion
• Adrenal Incidentaloma
• Non-functioning Adrenal Adenomas

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive function assessment; functional magnetic resonance imaging	cognitive function measurement
PROCEDURE	laparoscopic adrenal surgery	Only a subgroup of the autonomous cortisol secretion patients will have the laparoscopic adrenal surgery

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-10-01
• Completion: 2026-10-01
• First posted: 2022-05-02
• Last updated: 2022-05-02

Locations

1 site across 1 country: China