AzTrials
AzTrials

Autonomous Cortisol SecretionNCT05357456

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

An observational study of Autonomous Cortisol Secretion and Adrenal Incidentaloma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
What is being tested?
Cognitive function assessment; functional magnetic resonance imaging and laparoscopic adrenal surgery
How many people
62 participants
Where
1 siteChina
Study dates
1 Oct 2021to 1 Oct 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: autonomous cortisol secretion and non-functioning adrenal adenomas patients

Who may be able to join

  • 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.

Who cannot join

  • < 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;
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Dalong Zhu, MD,PhD contact

86-25-83-105302

zhudalong@nju.edu.cn

PIng Li, MD,PhD contact

86-25-83-105302

li78321@yeah.net

China1 site, 1 recruiting

  • Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School

    Nanjing, Jiangsu, 210008

    Dalong Zhu, MD,PhD, 86-25-83-105302, zhudalong@nju.edu.cn

    Ping Li, MD,PhD, 86-25-83-105302, li78321@yeah.net

    Recruiting

Other trials in China

About this study

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

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

Read the 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.

Being tested
Cognitive function assessment; functional magnetic resonance imaging, laparoscopic adrenal surgery
Keywords
cognitive function, functional MRI, treatment
Medical subject headings
Adrenal incidentaloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive function assessment; functional magnetic resonance imagingBehavioural

    Also called fMRI

    cognitive function measurement

  • laparoscopic adrenal surgeryProcedure or surgery

    Only a subgroup of the autonomous cortisol secretion patients will have the laparoscopic adrenal surgery

Study groups in NCT05357456
Study groupRoleWhat they receive
autonomous cortisol secretionPatients 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.
Receives: Behavioral: Cognitive function assessment; functional magnetic resonance imaging; Procedure: laparoscopic adrenal surgery
non-functioning adrenal adenomasPatients 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.
Receives: Behavioral: Cognitive function assessment; functional magnetic resonance imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants' personal information

    Self-reported information(education in years)

    Measured: 1 day

  2. Physical assessments

    BMI(body mess index) in kg/m^2

    Measured: 1 day

  3. Imaging examinations

    Adrenal adenoma size in cm

    Measured: 1 day

  4. Montreal Cognitive Assessment (MoCA)

    The MoCA is a Global cognitive screening test designed to assist Health Professionals in detection of mild cognitive impairment.

    Measured: 20 minutes

  5. Mini-Mental State Examination (MMSE)

    The MMSE is a cognitive screening test designed to assist Health Professionals in detection of mild cognitive impairment.

    Measured: 20 minutes

  6. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    The RBANS is a cognitive screening test designed to assist Health Professionals in evaluation of multiple cognitive subdomains

    Measured: 1 hour

  7. Rest Functional MRI of the brain function.

    Rs-fMRI

    Measured: 40 minutes

  8. Screening for adrenal cortisol hypersecretion

    Patients were given 1 mg dexamethasone orally at 24:00 am, and the cortisol levels were measured at 8:00 am the following morning

    Measured: 1 day

Secondary outcomes (6)

  1. Changes from basline global cognitive functions

    MoCA

    Measured: 12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]

  2. Changes from basline multiple cognitive subdomains

    RBANS

    Measured: 12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]

  3. Change from baseline Functional magnetic resonance imagine

    Rs-fMRI

    Measured: 12 months after the laparoscopic adrenal surgery (for patients with autonomous cortisol secretion who are willing to operate)]

  4. Changes from basline global cognitive functions

    MoCA

    Measured: 12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)]

  5. Changes from basline multiple cognitive subdomains

    RBANS

    Measured: 12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)]

  6. Change from baseline Functional magnetic resonance imagine

    Rs-fMRI

    Measured: 12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2022
  2. Study start1 Oct 2021
  3. Primary completion1 Oct 2024 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05357456
Sponsor's protocol ID
LP2022
Status last verified
Apr 2022
First submitted
27 Apr 2022
Last updated
2 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 36263685

Questions about this trial

What is this clinical trial studying?

An observational study of Autonomous Cortisol Secretion and Adrenal Incidentaloma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dalong Zhu, MD,PhD (86-25-83-105302, zhudalong@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants' personal information (time frame: 1 day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05357456, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in