The Intelligent Prevention And Control System And Strategy For The Whole Disease Cycle Of Diabetic Nephropathy

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Nephropathy; T2DM

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Zheyi Dong, MD; Phone Number: +86 13810261592; Email: shengdai26@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Zheyi Dong, MD; Phone Number: +8613810261592

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with type 2 diabetes mellitus and type 2 diabetes mellitus with CKD

Description

T2DM

Inclusion Criteria:

• Age ≥18 years old, gender is not limited
• Diagnosed with type 2 diabetes
• A history of type 2 diabetes for more than 5 years
• Negative proteinuria
• Creatinine is normal
• Good compliance, voluntarily sign informed consent

Exclusion Criteria:

• Incomplete medical records
• Lack of fundus microvascular examination or new imaging technology examination results data
• Combined with autoimmune diseases and tumors

Type 2 diabetes patients undergoing renal biopsy

Inclusion Criteria:

• Age ≥18 years old, gender is not limited
• Diagnosed with type 2 diabetes
• Kidney damage (microalbuminuria or dominant albuminuria or renal insufficiency)
• Have undergone renal puncture biopsy and have complete renal pathological diagnosis data
• Sign informed consent voluntarily

Exclusion Criteria:

• Gestational diabetes mellitus, special type diabetes mellitus
• Patients with hereditary kidney disease
• Combined with autoimmune diseases
• Diabetic nephropathy The indicators in the comprehensive assessment model of the risk of renal progression could not be obtained
• There were pregnancy plans in the study period

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Patients with type 2 diabetes mellitus and type 2 diabetes mellitus with CKD; Based on the national multi-center diabetic nephropathy cohort built since 2017, and continues to establish prospective diabetes nephropathy whole life cycle cohort. Individuals with type 2 diabetes will be followed up until renal dysfunction occurs and continue to be followed up until the occurrence of renal endpoints. Individuals with diabetic nephropathy of type 2 diabetes will be followed up until the occurrence of renal endpoints.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of complex renal endpoints	The incidence of complex renal endpoints includes eGFR decreased progressively by more than 30% from baseline, ESRD and all-cause death.	3 years

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): February 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Diabetes Mellitus; Diabetes Complications; Kidney Diseases; Diabetic Nephropathies
• Other Study ID Numbers: S2023-509-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No