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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

ConditionsAutonomous Cortisol SecretionAdrenal IncidentalomaNon-functioning Adrenal Adenomas
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-65
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

age 20-65 years;

≥ 6 years of education；

right-handed;

complete entire cognitive function tests;

Disqualifiers

< 6 years of education;

age < 20 years or > 65 years;

maximum diameter of AI <1cm;

active malignancies;

Trial population

autonomous cortisol secretion and non-functioning adrenal adenomas patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cognitive function assessment; functional magnetic resonance imaging

    Behavioral

    cognitive function measurement

  • laparoscopic adrenal surgery

    Procedure/Surgery

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

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: autonomous cortisol secretion2 interventions
Group B: non-functioning adrenal adenomas1 intervention

Trial outcomes

Primary outcomes

1

Participants' personal information

Self-reported information(education in years)

Time frame
1 day
2

Physical assessments

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

Time frame
1 day
3

Imaging examinations

Adrenal adenoma size in cm

Time frame
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.

Time frame
20 minutes

Secondary outcomes

1

Changes from basline global cognitive functions

MoCA

Time frame
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

Time frame
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

Time frame
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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Lead sponsor

Source ClinicalTrials.gov
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