The Intelligent Prevention And Control System And Strategy For The Whole Disease Cycle Of Diabetic Nephropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- The incidence of complex renal endpoints
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The incidence of complex renal endpoints
时间窗: 3 years
The incidence of complex renal endpoints includes eGFR decreased progressively by more than 30% from baseline, ESRD and all-cause death.
次要结局
未报告次要终点
研究者
Xiangmei Chen
Academician/Principal Investigator/ Clinical Professor/Director
Chinese PLA General Hospital
