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

• Conditions: Cognitive Impairment; Non-Alcoholic Fatty Liver Disease
• Interventions: Radiation: Cognitive assessment, functional magnetic resonance imaging

• Registration Number: NCT05563259
• Lead Sponsor: Yan Bi

Brief Summary

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

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 Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2022-09-27
• Primary Completion: 2022-09-30
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-03
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-21
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Groups/Cohorts Interventions Control	Cognitive assessment, functional magnetic resonance imaging	patients with steatosis \< 5%
NASH	Cognitive assessment, functional magnetic resonance imaging	patients with NAFLD Activity Score (NAS) ≥ 5
non-NASH	Cognitive assessment, functional magnetic resonance imaging	patients with steatosis ≥ 5% and did not achieve the criteria for NASH

Primary Outcome Measures

Name	Time	Method
Cognitive Assessment (MMSE)	1 day	Mini-Mental State Examination (MMSE) scores from 0-30, and the test means better cognition with a higher score.
Physical assessments.	1 day	BMI (body mass index) in kg/m\^2
Participants' personal information	1 day	Self-reported information (age in years, gender, education in years)
Cognitive Assessment (MoCA)	1 day	he Montreal Cognitive Assessment (MoCA) scores from 0-30, and the test means better cognition with a higher score.
Cognitive Assessment (RBANS)	1 day	The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores from 0-800, and the test means better cognition with a higher score.
brain activation in fMRI	1 day	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China