Correlation Study Between Clinical Phenotype and Pathology of Type 2 Diabetic Nephropathy

Chinese PLA General Hospital (301 Hospital)

Status: Enrolling

Conditions: Diabetic Kidney Disease

Study type: Observational

Funder types: Other

Identifiers

NCT03865914

S2017-133-01

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

2,000 participants in 1 patient group

Type 2 diabetic nephropathy

Description:

The cohort will be followed for at least 10 years. The cohort will be divided into 2 groups according the pathological results of patients,and at least 3 groups according to clinical features such as renal function and proteinuria.