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NCT Number: 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

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

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Nanjing, Jiangsu, 210008, China

Location status: Recruiting

Location contact

Dalong Zhu, MD,PhD

CONTACT

[email protected]

86-25-83-105302

Dalong Zhu, MD,PhD

PRINCIPAL_INVESTIGATOR

Ping Li, MD,PhD

CONTACT

[email protected]

86-25-83-105302

Ping Li, MD,PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive function assessment; functional magnetic resonance imaging

Behavioral

cognitive function measurement

Other names: fMRI

laparoscopic adrenal surgery

Procedure

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

Primary outcomes

  1. Participants' personal information

    Time frame: 1 day

    Self-reported information(education in years)

  2. Physical assessments

    Time frame: 1 day

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

  3. Imaging examinations

    Time frame: 1 day

    Adrenal adenoma size in cm

  4. 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.

  5. 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.

  6. 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

  7. Rest Functional MRI of the brain function.

    Time frame: 40 minutes

    Rs-fMRI

  8. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dalong Zhu, MD,PhD

CONTACT

[email protected]

86-25-83-105302

PIng Li, MD,PhD

CONTACT

[email protected]

86-25-83-105302

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
May 2, 2022
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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