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.

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Key information

Conditions

Diabetic Nephropathy Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases T2DM Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location status: Recruiting

Location contact

Zheyi Dong, MD

CONTACT

+8613810261592

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

The incidence of complex renal endpoints

Time frame: 3 years

The incidence of complex renal endpoints includes eGFR decreased progressively by more than 30% from baseline, ESRD and all-cause death.

Study contacts

Contact information is provided by the study sponsor or research team.

Zheyi Dong, MD

CONTACT

[email protected]

+86 13810261592

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: Feb 24, 2025
Registry last updated: Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting