Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-04-06 @ 2:38 PM
Study NCT ID:
NCT07437157
Status:
RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Establishment of Hong Kong Diabetes Steatotic Liver Disease Register
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '15 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-22', 'studyFirstSubmitQcDate': '2026-02-22', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '15 years', 'description': 'Death from any cause collected from hospital electronic medical record.'}], 'secondaryOutcomes': [{'measure': 'Fatal and non-fatal cardiovascular disease', 'timeFrame': '15 years', 'description': 'Incidence of fatal and non-fatal cardiovascular disease collected from hospital electronic medical record'}, {'measure': 'Heart failure', 'timeFrame': '15 years', 'description': 'Incidence of heart failure collected from hospital electronic medical record'}, {'measure': 'Hospitalizations', 'timeFrame': '15 years', 'description': 'Incidence of hospitalizations collected from hospital electronic medical record'}, {'measure': 'NT-proBNP levels', 'timeFrame': 'Baseline', 'description': 'NT-proBNP levels collected from blood sample'}, {'measure': 'Novel diagnostic markers of Metabolic dysfunction-associated steatohepatitis related to bile acid metabolism', 'timeFrame': 'Baseline', 'description': 'Novel diagnostic markers of Metabolic dysfunction-associated steatohepatitis, related to bile acid metabolism, collected from blood sample.\n\nThe novel biomarkers, cannot be disclosed in detail because the funding support is still pending (Project reference:T12-202/23-R). You can check on the website Theme-based Research Scheme (https://www.ugc.edu.hk/eng/rgc/funding\\_opport/trs/index.html) to enquire about what can be disclosed to the public.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Dysfunction-Associated Steatotic Liver Disease', 'Type 2 Diabetes (T2DM)']}, 'descriptionModule': {'briefSummary': 'Liver is an important organ in maintaining energy homeostasis. Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), is the most common chronic liver disease locally and globally. MASLD and type 2 diabetes mellitus (T2DM) are closely related with alarmingly high prevalence of MASLD in people with T2DM, along with the escalated risk of adverse clinical outcomes. Our group has reported that around 70% of people with T2DM have increased controlled attenuation parameter (CAP) suggestive of hepatic steatosis and one out of six had advanced liver fibrosis as evidenced by increased liver stiffness measurements (LSM). Despite its prevalence, close relationships and potential consequences, the mechanisms underlying the complex interconnections between MASLD and T2DM are not fully understood. MASLD is associated with a twofold higher risk of developing T2DM, independent of obesity and other common metabolic risk factors. This risk increases with the severity of MASLD, such that patients with more advanced stages of liver fibrosis are at a higher risk of developing T2DM. Moreover, the progression from hepatic steatosis to fibrosis is an important, yet not fully understood, step towards cirrhosis and end-stage liver disease. Identification of clinical predictors and biomarkers to select individuals with MAFLD for close monitoring is pivotal to prevent the sinister outcomes. To date, longitudinal cohorts with paired biobank focused on people with diabetes and comorbid MASLD for investigating the clinical courses and biomarkers for prediction of outcomes are lacking. We hypothesized that Hong Kong Chinese T2DM with comorbid steatotic liver disease have unique clinical courses and special biomarkers for predicting the progression to advanced liver fibrosis. The aims of this study are: 1) establish a prospective cohort of people with T2DM and comorbid steatotic liver disease accompanied with the setting up of a biobank; 2) elucidate the clinical courses and outcomes of Hong Kong Chinese T2DM with comorbid steatotic liver disease; 3) identify potential diagnostic markers of advanced liver fibrosis in people with T2DM and comorbid steatotic liver disease in Hong Kong. The primary outcome measure will be all-cause mortality and secondary outcome measure will be fatal and non-fatal CVD, heart failure, hospitalizations, NT-proBNP levels, and novel diagnostic markers of MASH in people with T2DM comorbid with MASLD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People with T2DM and comorbid Steatotic Liver Disease', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* T2DM.\n* Aged ≥ 18 years.\n* Able and willing to give Informed written consent.\n\nExclusion Criteria:\n\n* Type 1 diabetes.\n* Terminal illness such as malignancy with limited life expectancy.\n* Any condition, as judged by the investigators, as ineligible to participate in this study.'}, 'identificationModule': {'nctId': 'NCT07437157', 'briefTitle': 'The Establishment of Hong Kong Diabetes Steatotic Liver Disease Register', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'The Establishment of Hong Kong Diabetes Steatotic Liver Disease Register', 'orgStudyIdInfo': {'id': 'CREC2025.119'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SLD', 'description': 'Patients with Type 2 Diabetes will be recruited for biomarkers and genetic markers, as well as Fibroscan will be performed.', 'interventionNames': ['Other: No intervention (observational study)']}], 'interventions': [{'name': 'No intervention (observational study)', 'type': 'OTHER', 'description': 'There is no intervention involved in this observational study.', 'armGroupLabels': ['SLD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99977', 'city': 'Hong Kong', 'state': 'New Territories', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Alice Pik Shan Kong, MD', 'role': 'CONTACT', 'email': 'alicekong@cuhk.edu.hk', 'phone': '+852 3505 2648'}], 'facility': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong (CUHK), Ward 3M, Diabetes and Endocrine Research Centre, 3/F Day Treatment Block and Children Wards (Old Block), Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Alice Pik Shan Kong, MD', 'role': 'CONTACT', 'email': 'alicekong@cuhk.edu.hk', 'phone': '+852 3505 2648'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Alice Pik Shan KONG', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}