Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-02 @ 5:11 PM
Study NCT ID:
NCT06843304
Status:
RECRUITING
Last Update Posted:
2025-04-20
First Post:
2025-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Intelligent Prevention And Control System And Strategy For The Whole Disease Cycle Of Diabetic Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, urine, kidney tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2025-02-20', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of complex renal endpoints', 'timeFrame': '3 years', 'description': 'The incidence of complex renal endpoints includes eGFR decreased progressively by more than 30% from baseline, ESRD and all-cause death.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Nephropathy', 'T2DM']}, 'descriptionModule': {'briefSummary': 'Diabetic nephropathy is one of the most severe microvascular complications of diabetes and a major cause of premature death and disability. It has become a leading cause of end-stage renal failure both in China and worldwide, consuming substantial medical resources. The establishment of a comprehensive regulatory system for the development and progression of diabetic nephropathy is a critical need for effective prevention and control. However, there is a lack of representative cohorts covering the entire disease cycle of diabetic nephropathy both domestically and internationally, creating technical bottlenecks in comprehensively describing its developmental patterns. This project aims to expand and integrate existing large-sample natural population cohorts and prospective follow-up cohorts covering the entire disease cycle of diabetes and diabetic nephropathy. It will construct a panoramic life database to identify risk factors, clinical phenotypes, and multimodal biomarkers at different disease stages. By integrating multi-organ interactions (e.g., kidney, eye), the project will establish novel imaging and functional assessment technologies for microvascular complications. Utilizing artificial intelligence to process multimodal medical data, it will build and validate risk prediction models and evaluation systems for the entire disease cycle of diabetic nephropathy. The project will develop effective intelligent prevention and treatment strategies for diabetic nephropathy, promote the adoption of new technologies, and establish a medical quality control system to provide services for medical institutions. Ultimately, it aims to improve and sustain medical quality, reducing the incidence of end-stage renal disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with type 2 diabetes mellitus and type 2 diabetes mellitus with CKD', 'healthyVolunteers': False, 'eligibilityCriteria': 'T2DM\n\nInclusion Criteria:\n\n* Age ≥18 years old, gender is not limited\n* Diagnosed with type 2 diabetes\n* A history of type 2 diabetes for more than 5 years\n* Negative proteinuria\n* Creatinine is normal\n* Good compliance, voluntarily sign informed consent\n\nExclusion Criteria:\n\n* Incomplete medical records\n* Lack of fundus microvascular examination or new imaging technology examination results data\n* Combined with autoimmune diseases and tumors\n\nType 2 diabetes patients undergoing renal biopsy\n\nInclusion Criteria:\n\n* Age ≥18 years old, gender is not limited\n* Diagnosed with type 2 diabetes\n* Kidney damage (microalbuminuria or dominant albuminuria or renal insufficiency)\n* Have undergone renal puncture biopsy and have complete renal pathological diagnosis data\n* Sign informed consent voluntarily\n\nExclusion Criteria:\n\n* Gestational diabetes mellitus, special type diabetes mellitus\n* Patients with hereditary kidney disease\n* Combined with autoimmune diseases\n* Diabetic nephropathy The indicators in the comprehensive assessment model of the risk of renal progression could not be obtained\n* There were pregnancy plans in the study period'}, 'identificationModule': {'nctId': 'NCT06843304', 'briefTitle': 'The Intelligent Prevention And Control System And Strategy For The Whole Disease Cycle Of Diabetic Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'The Intelligent Prevention And Control System And Strategy For The Whole Disease Cycle Of Diabetic Nephropathy', 'orgStudyIdInfo': {'id': 'S2023-509-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with type 2 diabetes mellitus and type 2 diabetes mellitus with CKD', 'description': 'Based on the national multi-center diabetic nephropathy cohort built since 2017, and continues to establish prospective diabetes nephropathy whole life cycle cohort.\n\nIndividuals with type 2 diabetes will be followed up until renal dysfunction occurs and continue to be followed up until the occurrence of renal endpoints.\n\nIndividuals with diabetic nephropathy of type 2 diabetes will be followed up until the occurrence of renal endpoints.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zheyi Dong, MD', 'role': 'CONTACT', 'phone': '+8613810261592'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zheyi Dong, MD', 'role': 'CONTACT', 'email': 'shengdai26@163.com', 'phone': '+86 13810261592'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Academician/Principal Investigator/ Clinical Professor/Director', 'investigatorFullName': 'Xiangmei Chen', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}