Cognitive Assessment and Brain Function Evaluation in Patients With Non-alcoholic Fatty Liver Disease

NCT ID: NCT05563259

Last Updated: 2024-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2025-09-30

Brief Summary

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The purpose of this study is to explore the relationship between Non-alcoholic fatty liver disease and cognitive impairment and evaluate the effect of metabolic surgery or lifestyle intervention on cognition.

Detailed Description

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Previous research has shown that Non-alcoholic fatty liver disease (NAFLD) is associated with an increased risk of cognitive impairment. Even though there are many noninvasive tests available, a liver biopsy is still required for the accurate diagnosis of NAFLD. However, there are now few studies on cognitive function in patients with NAFLD based on pathological diagnosis. On one hand, in the cross-sectional study, biometric measurements, cognitive assessment, magnetic resonance imaging (MRI) results are analysed to explore the differences among control subjects and NAFLD patients undergoing liver biopsy. One the other hand, in the longitudinal study, changes in cognitive scales and MRI results in NAFLD patients both at baseline and 12-48 months after intervention are collected to investigate whether surgical intervention and weight control benefit brain function.

Conditions

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Non-Alcoholic Fatty Liver Disease Cognitive Impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Groups/Cohorts Interventions Control

patients with steatosis \< 5%

Cognitive assessment, functional magnetic resonance imaging

Intervention Type RADIATION

Our study investigated cognitive function, MRI measures of brain structure and activation in patients undergoing liver biopsy. We aimed to evaluate the changes of cognition during the process of NAFLD and explore the association between brain alterations and cognition.

non-NASH

patients with steatosis ≥ 5% and did not achieve the criteria for NASH

Cognitive assessment, functional magnetic resonance imaging

Intervention Type RADIATION

Our study investigated cognitive function, MRI measures of brain structure and activation in patients undergoing liver biopsy. We aimed to evaluate the changes of cognition during the process of NAFLD and explore the association between brain alterations and cognition.

NASH

patients with NAFLD Activity Score (NAS) ≥ 5

Cognitive assessment, functional magnetic resonance imaging

Intervention Type RADIATION

Our study investigated cognitive function, MRI measures of brain structure and activation in patients undergoing liver biopsy. We aimed to evaluate the changes of cognition during the process of NAFLD and explore the association between brain alterations and cognition.

Interventions

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Cognitive assessment, functional magnetic resonance imaging

Our study investigated cognitive function, MRI measures of brain structure and activation in patients undergoing liver biopsy. We aimed to evaluate the changes of cognition during the process of NAFLD and explore the association between brain alterations and cognition.

Intervention Type RADIATION

Other Intervention Names

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fMRI

Eligibility Criteria

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Inclusion Criteria

* \>6 years of education
* right handed

Exclusion Criteria

* consumed excessive alcohol (≥140 g/week for males or ≥ 70 g/week for females)
* with history of other liver diseases including chronic hepatitis, biliary obstructive diseases or autoimmune hepatitis
* with thyroid diseases
* in a state of anxiety or depression
* inability to complete cognitive function scales
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yan Bi

OTHER

Sponsor Role lead

Responsible Party

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Yan Bi

Chief Physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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NAFLDCOG

Identifier Type: -

Identifier Source: org_study_id

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