Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2026-01-03 @ 9:31 PM
Study NCT ID:
NCT07241195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Community-based Prospective Cohort Study on Metabolic Dysfunction-Associated Fatty Liver Disease in Older Adults: From Metabolic Trajectories to Extrahepatic Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of liver fibrosis', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Incidence of cardiovascular disease', 'timeFrame': '2 years'}, {'measure': 'Incidence of sarcopenia', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NAFLD and NASH', 'NAFLD( Non-alcoholic Fatty Liver Disease )', 'NAFLD Cirrhosis']}, 'descriptionModule': {'briefSummary': 'To establish a cohort of elderly fatty liver disease based on the community medical examination population. Through the large-scale cohort study, the risk factors affecting fatty liver in the elderly will be explored in depth from the aspects of lifestyle, environment and genetics, the development pattern and mechanism of fatty liver in the elderly will be analysed, and the health risk assessment system and Chinese standard for fatty liver in the elderly covering cardiovascular risk, risk of hepatic fibrosis and risk of sarcopenia will be established, so as to provide the scientific basis for the precise intervention of fatty liver in the elderly in China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'elder people', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ① Elderly people aged ≥65 years among permanent residents (living for more than 5 years) in the survey area;\n\n * Imaging diagnosis (ultrasound or FibroScan/FibroTouch) of fatty liver; -③ Voluntary participation in this study and signing an informed consent form.\n\nExclusion Criteria:\n\n* ①Major disability, mental illness, major wasting disease, severe cardiac, pulmonary and renal insufficiency;\n\n * Patients with combined primary liver cancer or other types of cancer; -③Patients who have received liver transplant or other organ transplants.'}, 'identificationModule': {'nctId': 'NCT07241195', 'acronym': 'MAPS Cohort', 'briefTitle': 'A Community-based Prospective Cohort Study on Metabolic Dysfunction-Associated Fatty Liver Disease in Older Adults: From Metabolic Trajectories to Extrahepatic Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Hangzhou Normal University'}, 'officialTitle': 'Study on the Construction of Disease Cohort for Fatty Liver in the Elderly and Its Prevention and Treatment Strategies', 'orgStudyIdInfo': {'id': 'SJP20250401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control group'}, {'label': 'Observation Group', 'description': 'Lifestyle interventions'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wei Zhang, DR', 'role': 'CONTACT', 'email': 'zhangwei969696@163.com', 'phone': '+8613567135527'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Hangzhou Normal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}