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RecruitingNCT06843304Updated Apr 20, 2025

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

An observational study in Diabetic Nephropathy and T2DM, sponsored by Chinese PLA General Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-20.

Sponsored by Chinese PLA General Hospital · Observational

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Diabetic Nephropathy
  • T2DM
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Eligibility criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Chinese PLA General Hospital
    Beijing, Beijing 100853, China
    • Zheyi Dong, MD · Contact · +8613810261592
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06843304
Lead sponsor
Chinese PLA General Hospital
Responsible party
Xiangmei Chen (Academician/Principal Investigator/ Clinical Professor/Director, Chinese PLA General Hospital) — Principal investigator
First posted
Feb 24, 2025
Start date
Jan 1, 2024
Primary completion
Dec 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Apr 20, 2025

Study contacts

Zheyi Dong, MD
Contact
shengdai26@163.com
+86 13810261592

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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