Clinical trial NCT05563259: Cognitive Assessment and Brain Function Evaluation in Patients With Non-alcoholic Fatty Liver Disease
Official title: The Cross-sectional and Longitudinal Study of Relationship Between Non-alcoholic Fatty Liver Disease and Cognitive Impairment
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Non-Alcoholic Fatty Liver Disease
Cognitive Impairment
Keywords: MRI
cognitive function
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Participants' personal information
timeFrame: 1 day
measure: Physical assessments.
timeFrame: 1 day
measure: Cognitive Assessment (MMSE)
timeFrame: 1 day
measure: Cognitive Assessment (MoCA)
timeFrame: 1 day
measure: Cognitive Assessment (RBANS)
timeFrame: 1 day
measure: brain activation in fMRI
timeFrame: 1 day
Secondary outcomes:
measure: Change of weight from baseline
timeFrame: 12-48 months
measure: Change of Cognitive Assessment (MMSE) from baseline
timeFrame: 12-48 months
measure: Change of Cognitive Assessment (MoCA) from baseline
timeFrame: 12-48 months
measure: Change of Cognitive Assessment (RBANS) from baseline
timeFrame: 12-48 months
measure: Change of brain MRI measurement from baseline
timeFrame: 12-48 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
state: Jiangsu
Study officials:
References: