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

April 27, 2022 updated by: Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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 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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

autonomous cortisol secretion and non-functioning adrenal adenomas patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
autonomous cortisol secretion
Patients admitted to the hospital with adrenal incidentalomas are evaluated for adrenal function, and then ACS patients are diagnosed based on the serum cortisol ≥ 50 nmol/L following the 1 mg dexamethasone suppression test and without any other signs or symptoms of cortisol excess.Patients with ACS will undergo a physical exam, cognitive function test as well as structural and functional brain MRI at baseline and 12 months after their surgery or conservative treatment.
Behavioral: Cognitive function assessment; functional magnetic resonance imaging
cognitive function measurement
Other Names:
  • fMRI
Procedure: laparoscopic adrenal surgery
Only a subgroup of the autonomous cortisol secretion patients will have the laparoscopic adrenal surgery
non-functioning adrenal adenomas
Patients admitted to the hospital with adrenal incidentalomas are evaluated for adrenal function, and then non-functioning adrenal adenomas patients are diagnosed based on the serum cortisol < 50 nmol/L following the 1 mg dexamethasone suppression test .Patients with non-functioning adrenal adenomas will undergo a physical exam, cognitive function test as well as structural and functional brain MRI at baseline.
Behavioral: Cognitive function assessment; functional magnetic resonance imaging
cognitive function measurement
Other Names:
  • fMRI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participants' personal information
Time Frame: 1 day
Self-reported information(education in years)
1 day
Physical assessments
Time Frame: 1 day
BMI(body mess index) in kg/m^2
1 day
Imaging examinations
Time Frame: 1 day
Adrenal adenoma size in cm
1 day
Montreal Cognitive Assessment (MoCA)
Time Frame: 20 minutes
The MoCA is a Global cognitive screening test designed to assist Health Professionals in detection of mild cognitive impairment.
20 minutes
Mini-Mental State Examination (MMSE)
Time Frame: 20 minutes
The MMSE is a cognitive screening test designed to assist Health Professionals in detection of mild cognitive impairment.
20 minutes
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time Frame: 1 hour
The RBANS is a cognitive screening test designed to assist Health Professionals in evaluation of multiple cognitive subdomains
1 hour
Rest Functional MRI of the brain function.
Time Frame: 40 minutes
Rs-fMRI
40 minutes
Screening for adrenal cortisol hypersecretion
Time Frame: 1 day
Patients were given 1 mg dexamethasone orally at 24:00 am, and the cortisol levels were measured at 8:00 am the following morning
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)]
MoCA
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)]
RBANS
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)]
Rs-fMRI
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)]
MoCA
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)]
RBANS
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)]
Rs-fMRI
12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LP2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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