Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-25 @ 11:05 PM
Study NCT ID:
NCT05563259
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-21
First Post:
2022-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Assessment and Brain Function Evaluation in Patients With Non-alcoholic Fatty Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-20', 'studyFirstSubmitDate': '2022-09-27', 'studyFirstSubmitQcDate': '2022-09-30', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Participants' personal information", 'timeFrame': '1 day', 'description': 'Self-reported information (age in years, gender, education in years)'}, {'measure': 'Physical assessments.', 'timeFrame': '1 day', 'description': 'BMI (body mass index) in kg/m\\^2'}, {'measure': 'Cognitive Assessment (MMSE)', 'timeFrame': '1 day', 'description': 'Mini-Mental State Examination (MMSE) scores from 0-30, and the test means better cognition with a higher score.'}, {'measure': 'Cognitive Assessment (MoCA)', 'timeFrame': '1 day', 'description': 'he Montreal Cognitive Assessment (MoCA) scores from 0-30, and the test means better cognition with a higher score.'}, {'measure': 'Cognitive Assessment (RBANS)', 'timeFrame': '1 day', 'description': 'The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores from 0-800, and the test means better cognition with a higher score.'}, {'measure': 'brain activation in fMRI', 'timeFrame': '1 day', 'description': '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.\n\nThe 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.'}], 'secondaryOutcomes': [{'measure': 'Change of weight from baseline', 'timeFrame': '12-48 months', 'description': 'whether body weight (kg) changes during follow-up'}, {'measure': 'Change of Cognitive Assessment (MMSE) from baseline', 'timeFrame': '12-48 months', 'description': 'Whether Mini-Mental State Examination (MMSE, scores from 0-30) changes during follow-up, and the test means better cognition with a higher score.'}, {'measure': 'Change of Cognitive Assessment (MoCA) from baseline', 'timeFrame': '12-48 months', 'description': 'Whether the Montreal Cognitive Assessment (MoCA, scores from 0-30) change during follow-up, and the test means better cognition with a higher score.'}, {'measure': 'Change of Cognitive Assessment (RBANS) from baseline', 'timeFrame': '12-48 months', 'description': '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.'}, {'measure': 'Change of brain MRI measurement from baseline', 'timeFrame': '12-48 months', 'description': 'whether brain activation changes during follow-up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRI', 'cognitive function'], 'conditions': ['Non-Alcoholic Fatty Liver Disease', 'Cognitive Impairment']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>6 years of education\n* right handed\n\nExclusion Criteria:\n\n* consumed excessive alcohol (≥140 g/week for males or ≥ 70 g/week for females)\n* with history of other liver diseases including chronic hepatitis, biliary obstructive diseases or autoimmune hepatitis\n* with thyroid diseases\n* in a state of anxiety or depression\n* inability to complete cognitive function scales'}, 'identificationModule': {'nctId': 'NCT05563259', 'briefTitle': 'Cognitive Assessment and Brain Function Evaluation in Patients With Non-alcoholic Fatty Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'The Cross-sectional and Longitudinal Study of Relationship Between Non-alcoholic Fatty Liver Disease and Cognitive Impairment', 'orgStudyIdInfo': {'id': 'NAFLDCOG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Groups/Cohorts Interventions Control', 'description': 'patients with steatosis \\< 5%', 'interventionNames': ['Radiation: Cognitive assessment, functional magnetic resonance imaging']}, {'label': 'non-NASH', 'description': 'patients with steatosis ≥ 5% and did not achieve the criteria for NASH', 'interventionNames': ['Radiation: Cognitive assessment, functional magnetic resonance imaging']}, {'label': 'NASH', 'description': 'patients with NAFLD Activity Score (NAS) ≥ 5', 'interventionNames': ['Radiation: Cognitive assessment, functional magnetic resonance imaging']}], 'interventions': [{'name': 'Cognitive assessment, functional magnetic resonance imaging', 'type': 'RADIATION', 'otherNames': ['fMRI'], 'description': '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.', 'armGroupLabels': ['Groups/Cohorts Interventions Control', 'NASH', 'non-NASH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yan Bi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Yan Bi', 'investigatorAffiliation': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}}}}