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

The Cross-sectional and Longitudinal Study of Relationship Between Non-alcoholic Fatty Liver Disease and Cognitive Impairment

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cognitive Impairment; Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Radiation: Cognitive assessment, functional magnetic resonance imaging

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

We enrolled subjects who were planning to undergo bariatric surgery in Drum Tower Hospital affiliated to Nanjing University Medical School and conducted cognitive assessment and MRI scanning within one year of biopsy.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Groups/Cohorts Interventions Control; patients with steatosis < 5%	Radiation: 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.; Other Names: fMRI
non-NASH; patients with steatosis ≥ 5% and did not achieve the criteria for NASH	Radiation: 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.; Other Names: fMRI
NASH; patients with NAFLD Activity Score (NAS) ≥ 5	Radiation: 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.; Other Names: fMRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants' personal information	Self-reported information (age in years, gender, education in years)	1 day
Physical assessments.	BMI (body mass index) in kg/m^2	1 day
Cognitive Assessment (MMSE)	Mini-Mental State Examination (MMSE) scores from 0-30, and the test means better cognition with a higher score.	1 day
Cognitive Assessment (MoCA)	he Montreal Cognitive Assessment (MoCA) scores from 0-30, and the test means better cognition with a higher score.	1 day
Cognitive Assessment (RBANS)	The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores from 0-800, and the test means better cognition with a higher score.	1 day
brain activation in fMRI	All patients underwent odor-induced task fMRI on a 3.0T MR scanner with 222 volumes for task fMRI and 230 volumes for resting-state and functional fMRI. The odor-induced task consisted of "fresh air" "rest" and "scent". Odor-induced brain activation was assessed by a general linear model using Statistical Parametric Mapping 12 (SPM12) software. Following extraction of the three separate conditions "fresh air," "scent," and "rest" from the whole sequence, contrasts were made for each participant between "fresh air > rest" and "scent > rest." Odor-induced fMRI data were analyzed in the mask of the olfactory network, including the regions of bilateral parahippocampus, amygdala, piriform cortex, insula, orbitofrontal cortex, hippocampus, and entorhinal cortices.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of weight from baseline	whether body weight (kg) changes during follow-up	12-48 months
Change of Cognitive Assessment (MMSE) from baseline	Whether Mini-Mental State Examination (MMSE, scores from 0-30) changes during follow-up, and the test means better cognition with a higher score.	12-48 months
Change of Cognitive Assessment (MoCA) from baseline	Whether the Montreal Cognitive Assessment (MoCA, scores from 0-30) change during follow-up, and the test means better cognition with a higher score.	12-48 months
Change of Cognitive Assessment (RBANS) from baseline	Whether the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS, scores from 0-800) changes during follow-up, and the test means better cognition with a higher score.	12-48 months
Change of brain MRI measurement from baseline	whether brain activation changes during follow-up	12-48 months

Collaborators and Investigators

• Sponsor: Yan Bi

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): September 30, 2022
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: MRI; cognitive function
• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Neurocognitive Disorders; Cognition Disorders; Liver Diseases; Fatty Liver; Cognitive Dysfunction; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: NAFLDCOG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No