Non-Alcoholic Fatty Liver DiseaseNCT05563259
Cognitive Assessment and Brain Function Evaluation in Patients With Non-alcoholic Fatty Liver Disease
An observational study of Non-Alcoholic Fatty Liver Disease and Cognitive Impairment, run by Yan Bi at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Cognitive Impairment
- What is being tested?
- Cognitive assessment, functional magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- >6 years of education
- right handed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, 210008
About this study
Official title: The Cross-sectional and Longitudinal Study of Relationship Between Non-alcoholic Fatty Liver Disease and Cognitive Impairment
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.
Read the 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.
- Being tested
- Cognitive assessment, functional magnetic resonance imaging
- Keywords
- MRI, cognitive function
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive assessment, functional magnetic resonance imagingRadiation
Also called fMRI
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.
| Study group | Role | What they receive |
|---|---|---|
| Groups/Cohorts Interventions Control | patients with steatosis < 5% Receives: Radiation: Cognitive assessment, functional magnetic resonance imaging | |
| non-NASH | patients with steatosis ≥ 5% and did not achieve the criteria for NASH Receives: Radiation: Cognitive assessment, functional magnetic resonance imaging | |
| NASH | patients with NAFLD Activity Score (NAS) ≥ 5 Receives: Radiation: Cognitive assessment, functional magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' personal information
Self-reported information (age in years, gender, education in years)
Measured: 1 day
Physical assessments.
BMI (body mass index) in kg/m^2
Measured: 1 day
Cognitive Assessment (MMSE)
Mini-Mental State Examination (MMSE) scores from 0-30, and the test means better cognition with a higher score.
Measured: 1 day
Cognitive Assessment (MoCA)
he Montreal Cognitive Assessment (MoCA) scores from 0-30, and the test means better cognition with a higher score.
Measured: 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.
Measured: 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.
Measured: 1 day
Secondary outcomes (5)
Change of weight from baseline
whether body weight (kg) changes during follow-up
Measured: 12-48 months
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.
Measured: 12-48 months
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.
Measured: 12-48 months
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.
Measured: 12-48 months
Change of brain MRI measurement from baseline
whether brain activation changes during follow-up
Measured: 12-48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start1 May 2020
- Primary completion30 Sep 2022
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan Bi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yan Bi, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563259
- Sponsor's protocol ID
- NAFLDCOG
- Status last verified
- Jun 2024
- First submitted
- 27 Sep 2022
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cross-sectional and Longitudinal Study of Relationship Between Non-alcoholic Fatty Liver Disease and Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05563259
- Acronym / sponsor ID
- NAFLDCOG
- Keywords
- MRI, cognitive function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Yan BiUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Groups/Cohorts Interventions Control | – | Radiation: Cognitive assessment, functional magnetic resonance imagingpatients with steatosis < 5% |
| non-NASH | – | Radiation: Cognitive assessment, functional magnetic resonance imagingpatients with steatosis ≥ 5% and did not achieve the criteria for NASH |
| NASH | – | Radiation: Cognitive assessment, functional magnetic resonance imagingpatients with NAFLD Activity Score (NAS) ≥ 5 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- >6 years of education
- right handed
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive assessment, functional magnetic resonance imagingAlso: fMRIOur 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. | Radiation | Groups/Cohorts Interventions Control, NASH, non-NASH |
Primary outcome
Participants' personal information
Time frame: 1 day
Self-reported information (age in years, gender, education in years)
Physical assessments.
Time frame: 1 day
BMI (body mass index) in kg/m^2
Cognitive Assessment (MMSE)
Time frame: 1 day
Mini-Mental State Examination (MMSE) scores from 0-30, and the test means better cognition with a higher score.
Cognitive Assessment (MoCA)
Time frame: 1 day
he Montreal Cognitive Assessment (MoCA) scores from 0-30, and the test means better cognition with a higher score.
Cognitive Assessment (RBANS)
Time frame: 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
Time frame: 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.
5 secondary outcomes
Change of weight from baseline
Time frame: 12-48 months
Change of Cognitive Assessment (MMSE) from baseline
Time frame: 12-48 months
Change of Cognitive Assessment (MoCA) from baseline
Time frame: 12-48 months
Change of Cognitive Assessment (RBANS) from baseline
Time frame: 12-48 months
Change of brain MRI measurement from baseline
Time frame: 12-48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease and Cognitive Impairment, run by Yan Bi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' personal information (time frame: 1 day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.