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

NCT05563259 | Enrolling By Invitation

• 1 other identifier: NAFLDCOG
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Fatty Liver Disease; Cognitive Impairment

Keywords

MRI; cognitive function

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Change of weight from baseline

  12-48 months

• Change of Cognitive Assessment (MMSE) from baseline

  12-48 months

• Change of Cognitive Assessment (MoCA) from baseline

  12-48 months

• Change of Cognitive Assessment (RBANS) from baseline

  12-48 months

• Change of brain MRI measurement from baseline

  12-48 months

Study Arms (3)

Groups/Cohorts Interventions Control

patients with steatosis \< 5%

Radiation: Cognitive assessment, functional magnetic resonance imaging

non-NASH

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

Radiation: Cognitive assessment, functional magnetic resonance imaging

NASH

patients with NAFLD Activity Score (NAS) ≥ 5

Radiation: Cognitive assessment, functional magnetic resonance imaging

Interventions

Cognitive assessment, functional magnetic resonance imaging 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.

Also known as: fMRI

Groups/Cohorts Interventions Control; NASH; non-NASH

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \>6 years of education
• right handed

You may not qualify if:

• 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

Sponsors & Collaborators

• Yan Bi: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 3, 2022
• Study Start: May 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 1, 2025
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)