Multidimensional Accurate Diagnosis and Treatment Technology and Clinical Transformation of Type 2 Diabetes Nephropathy

Sponsor

Chinese PLA General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05888909

Collaborator

Beijing Municipal Science & Technology Commission (Other), China-Japan Friendship Hospital (Other), Beijing Friendship Hospital (Other), Beijing Tongren Hospital (Other), Beijing Hospital (Other), Dongzhimen Hospital, Beijing (Other), Xuanwu Hospital, Beijing (Other)

2,000

Enrollment

Location

Anticipated Duration (Months)

37.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Diabetes nephropathy (DN) is one of the most serious microvascular complications of diabetes, and also an important cause of death and disability of diabetes patients. There is no specific clinical staging of type 2 diabetes nephropathy at home and abroad, and there is no comprehensive study to comprehensively describe the occurrence and development of type 2 diabetes nephropathy through sensitive biomarkers, microvascular disease imaging and functional detection, digital markers and other multi-dimensional diagnosis and evaluation methods. Therefore, our research aims to establish a long-term follow-up queue for the whole cycle of diabetes nephropathy, develop multi-dimensional diagnostic and progress digital markers for diabetes nephropathy, develop a multimodal non-invasive diagnostic model and a new clinical staging/typing, and create a multi-dimensional accurate diagnosis and treatment system for type 2 diabetes nephropathy combining traditional Chinese and western medicine.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Nephropathy Type 2 Diabetic Kidney Disease Type 2 Diabetes

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Multidimensional Accurate Diagnosis and Treatment Technology and Clinical Transformation of Type 2 Diabetes Nephropathy

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Type 2 diabetic nephropathy The cohort will be divided into 2 or 3 groups according the pathological results of patients,and at least 3 groups according to clinical features such as renal function and proteinuria.

Outcome Measures

Primary Outcome Measures

change in estimated glomerular filtration rate (eGFR) from baseline [24months]
eGFR is calculated using the CKD-EPI formula, involving gender, age, and serum creatinine.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Age ≥ 18 years old, regardless of gender; Type 2 diabetes; Having a complete medical history and clinical data; If the patients with type 2 diabetes combined with CKD underwent renal biopsy, the pathological diagnosis should be clear; Patients voluntarily signs an informed consent form.

Exclusion criteria:

Incomplete medical history or clinical data; Patients with hereditary kidney disease; Combined urinary tract infection; Merge autoimmune system diseases; Patients with malignant tumor were expected to survive less than 6 months; Pregnancy and lactation.