Clinical trial NCT06843304: The Intelligent Prevention And Control System And Strategy For The Whole Disease Cycle Of Diabetic Nephropathy
Official title: The Intelligent Prevention And Control System And Strategy For The Whole Disease Cycle Of Diabetic Nephropathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Nephropathy
T2DM
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes mellitus and type 2 diabetes mellitus with CKD

Brief 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: 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

Primary outcomes:
measure: The incidence of complex renal endpoints
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References: