The Intelligent Prevention and Control System and Strategy for the Whole Disease Cycle of Diabetic Nephropathy

Last updated: February 20, 2025
Sponsor: Chinese PLA General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetic Kidney Disease

Diabetes (Pediatric)

Diabetes Mellitus Types I And Ii

Treatment

N/A

Clinical Study ID

NCT06843304
S2023-509-01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

T2DM------

Inclusion Criteria:

  • Age ≥18 years old, gender is not limited;

  • Diagnosed with type 2 diabetes; ③A history of type 2 diabetes for more than 5years; Negative proteinuria; Creatinine is normal;

  • Good compliance, voluntarily sign informed consent.

Exclusion

Exclusion Criteria:

① Incomplete medical records;

  • Lack of fundus microvascular examination or new imaging technology examinationresults data; ③ Combined with autoimmune diseases and tumors. Healthy person------

Inclusion criteria:

  • Age 40-80 years old, gender is not limited; ② Good compliance, voluntarily signinformed consent.

Exclusion criteria:

  • Incomplete medical records; ②Combined with diabetes, hypertension, coronary heartdisease and other basic diseases.

Type 2 diabetes patients undergoing renal biopsy------

Inclusion criteria: All of the following must be met for inclusion:

  • Age ≥18 years old, gender is not limited;

  • Diagnosed with type 2 diabetes;

  • Kidney damage (microalbuminuria or dominant albuminuria or renalinsufficiency); ④Have undergone renal puncture biopsy and have completerenal pathological diagnosis data; ⑤ Sign informed consent voluntarily.

Exclusion criteria: Any of the following criteria will be excluded:

  • Gestational diabetes mellitus, special type diabetes mellitus

  • Patients with hereditary kidney disease ③ Combined with autoimmune diseases ④Diabetic nephropathy The indicators in the comprehensive assessment model ofthe risk of renal progression could not be obtained ⑤ There were pregnancyplans in the study period

Study Design

Total Participants: 3000
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Chinese PLA General Hospital

    Beijing, Beijing 100853
    China

    Active - Recruiting

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