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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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05563259
Enrollment
500
Registered
2022-10-03
Start date
2020-05-01
Completion date
2025-09-30
Last updated
2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment, Non-Alcoholic Fatty Liver Disease

Keywords

MRI, cognitive function

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.

Interventions

RADIATIONCognitive 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.

Sponsors

Yan Bi
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
brain activation in fMRI1 dayAll 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.
Participants' personal information1 daySelf-reported information (age in years, gender, education in years)
Physical assessments.1 dayBMI (body mass index) in kg/m\^2
Cognitive Assessment (MMSE)1 dayMini-Mental State Examination (MMSE) scores from 0-30, and the test means better cognition with a higher score.
Cognitive Assessment (MoCA)1 dayhe Montreal Cognitive Assessment (MoCA) scores from 0-30, and the test means better cognition with a higher score.
Cognitive Assessment (RBANS)1 dayThe Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores from 0-800, and the test means better cognition with a higher score.

Secondary

MeasureTime frameDescription
Change of Cognitive Assessment (MMSE) from baseline12-48 monthsWhether 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 Cognitive Assessment (MoCA) from baseline12-48 monthsWhether the Montreal Cognitive Assessment (MoCA, scores from 0-30) change during follow-up, and the test means better cognition with a higher score.
Change of Cognitive Assessment (RBANS) from baseline12-48 monthsWhether 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 brain MRI measurement from baseline12-48 monthswhether brain activation changes during follow-up
Change of weight from baseline12-48 monthswhether body weight (kg) changes during follow-up

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026