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Recruiting 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

— Observational Autonomous Cortisol Secretion Adrenal Incidentaloma Non-functioning Adrenal Adenomas

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive function assessment; functional magnetic resonance imaging, laparoscopic adrenal surgery.
Who it may be relevant to
Registry conditions: Autonomous Cortisol Secretion, Adrenal Incidentaloma, Non-functioning Adrenal Adenomas. Basic parameters: 20 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Participants' personal information [Time frame: 1 day]
  • Physical assessments [Time frame: 1 day]
  • Imaging examinations [Time frame: 1 day]
  • Montreal Cognitive Assessment (MoCA) [Time frame: 20 minutes]
  • Mini-Mental State Examination (MMSE) [Time frame: 20 minutes]
  • Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [Time frame: 1 hour]
  • Rest Functional MRI of the brain function. [Time frame: 40 minutes]
  • Screening for adrenal cortisol hypersecretion [Time frame: 1 day]
Secondary outcome measures (6)
  • Changes from basline global cognitive functions [Time frame: 12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]]
  • Changes from basline multiple cognitive subdomains [Time frame: 12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]]
  • Change from baseline Functional magnetic resonance imagine [Time frame: 12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]]
  • Changes from basline global cognitive functions [Time frame: 12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)]]
  • Changes from basline multiple cognitive subdomains [Time frame: 12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)]]
  • Change from baseline Functional magnetic resonance imagine [Time frame: 12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)]]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical — Nanjing

Publications

  • Liu MS, Tian ZY, Zhang Z, Yang F, Lou Y, Wang YJ, Zeng YJ, Zhang ZW, Zhu DL, Li P. Impaired Cognitive Function in Patients With Autonomous Cortisol Secretion in Adrenal Incidentalomas. J Clin Endocrinol Metab. 2023 Feb 15;108(3):633-641. doi: 10.1210/clinem/dgac603. PMID 36263685

Identifiers

NCT: NCT05357456 · LP2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗