Correlation Study Between Clinical Phenotype and Pathology of Type 2 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
- change in eGFR and urine protein from baseline
研究概览
简要总结
With the rapid increase of diabetic nephropathy worldwide, type 2 diabetes mellitus(DM) is the leading cause of end-stage renal disease(ESRD). Pathological types of diabetic kidney disease(DKD) could be mainly divided into diabetic nephropathy（DN）and non-diabetic renal diseases（NDRD）. There are no accurate renal biopsy indications and standardized operation procedures for type 2 diabetic nephropathy. The clinical stages of type 2 diabetic nephropathy still referred to the Mogensen stage of type 1 diabetic nephropathy. Thus, our study aim to clarify the differences in clinical phenotype between type 2 DN and type 2 NDRD, analysis the correlation between clinical and pathological features, and offer the criteria for clinical staging and prognosis.
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, male or female
- •Clinical diagnosed as type 2 diabetes mellitus
- •The presence of renal impairment including: microalbuminuria or overt proteinuria or renal insufficiency
- •The renal biopsy was performed with complete renal pathological diagnosis
- •Obtaining the signed informed consent from patients
排除标准
- •The history of the disease was not complete
- •Clinical diagnosed as other secondary renal diseases
- •Patients with hereditary kidney disease
- •Autoimmune diseases
- •Patients with malignant tumor were expected to survive less than 6 months
- •Pregnancy and lactation
结局指标
主要结局
change in eGFR and urine protein from baseline
时间窗: 24months
eGFR is calculated using the CKD-EPI formula, involving gender, age, and serum creatinine.
次要结局
未报告次要终点
研究者
Xiangmei Chen
Professor,Chief physician,Academician of Chinese Academy of Engineering
Chinese PLA General Hospital