Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:27 AM
Study NCT ID:
NCT07492004
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
China Monogenic Diabetes Registry
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, plasma and complete blood cell'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2030-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-19', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Screened and confirmed monogenic diabetes', 'timeFrame': '6 months', 'description': 'Screened and confirmed through genetic testing according to established diagnostic criteria for monogenic forms of diabetes (including MODY, neonatal diabetes, and other monogenic subtypes)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Monogenic Diabetes', 'Neonatal Diabetes', 'Maturity Onset Diabetes of the Young'], 'conditions': ['Neonatal Diabetes', 'Monogenic Diabetes', 'Maturity Onset Diabetes of the Young']}, 'descriptionModule': {'briefSummary': 'This observational study aims to establish a digital registry, screening platform for patients with monogenic diabetes using internet-based and mobile application technologies. The primary objectives are to:\n\nCharacterize the genetic landscape of monogenic diabetes in the Chinese population, including pathogenic variants and their distribution\n\nParticipants will:\n\n* Enroll in the monogenic diabetes registry via mobile application or web-based platform\n* Undergo molecular genetic testing to establish a definitive diagnosis', 'detailedDescription': 'This study will include the subjects of a series of studies on monogenic diabetes conducted by our team, including neonatal diabetes, maturity-onset diabetes of the young, maternally inherited diabetes and deafness, and other monogenic diabetes caused by different causative genes, and establish a large sample database and specimen bank through follow-up and omics analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diabetes patients who completed gene test and necessary further tests and voluntary to be followed up will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diabetes diagnosed before 25 years of age; OR diabetes diagnosed before 35 years of age with ≥1 first-degree relative (parent, sibling, or offspring) diagnosed with diabetes before 40 years of age\n2. Body mass index (BMI) at diagnosis 28 kg/m²\n3. Negative glutamic acid decarboxylase antibody (GAD-Ab)\n\nExclusion Criteria:\n\n1. Secondary diabetes\n2. Active malignancy or history of malignant tumor within the past 5 years'}, 'identificationModule': {'nctId': 'NCT07492004', 'acronym': 'CMDR', 'briefTitle': 'China Monogenic Diabetes Registry', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University General Hospital'}, 'officialTitle': 'China Monogenic Diabetes Registry', 'orgStudyIdInfo': {'id': 'IRB2022-YX-164-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Monogenic Diabetes', 'interventionNames': ['Other: No Interventions']}], 'interventions': [{'name': 'No Interventions', 'type': 'OTHER', 'description': 'No Interventions', 'armGroupLabels': ['Monogenic Diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300052', 'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ming Liu', 'role': 'CONTACT', 'email': 'mingliu@tmu.edu.cn', 'phone': '+86 022-27813550'}, {'name': 'Hua Shu', 'role': 'CONTACT', 'email': 'shuhuawelcome@163.com', 'phone': '+86 15010106182'}], 'facility': 'Tianjin medical university general hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Ming Liu', 'role': 'CONTACT', 'email': 'mingliu@tmu.edu.cn', 'phone': '+86 022-27813550'}, {'name': 'Hua Shu', 'role': 'CONTACT', 'email': 'shuhuawelcome@163.com', 'phone': '+86 15010106182'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Hua Shu', 'investigatorAffiliation': 'Tianjin Medical University General Hospital'}}}}