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

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05563259
• Other study ID #: NAFLDCOG
• Status: Enrolling by invitation
• Start date: May 1, 2020
• Est. completion date: September 2025

Study information

• Verified date: June 2024
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: September 2025
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

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.

Locations

Country	Name	City	State
China	at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yan Bi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants' personal information	Self-reported information (age in years, gender, education in years)	1 day
Primary	Physical assessments.	BMI (body mass index) in kg/m^2	1 day
Primary	Cognitive Assessment (MMSE)	Mini-Mental State Examination (MMSE) scores from 0-30, and the test means better cognition with a higher score.	1 day
Primary	Cognitive Assessment (MoCA)	he Montreal Cognitive Assessment (MoCA) scores from 0-30, and the test means better cognition with a higher score.	1 day
Primary	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
Primary	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	Change of weight from baseline	whether body weight (kg) changes during follow-up	12-48 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Change of brain MRI measurement from baseline	whether brain activation changes during follow-up	12-48 months