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

ClinicalTrials.gov IDNCT03865914

PhaseNot Applicable

Enrollment2000

SponsorChinese PLA General Hospital

Age18 Years

SexALL

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Conditions studied

Diabetic Kidney Disease

About this study

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.

Primary outcomes

change in eGFR and urine protein from baseline (24months)

Eligibility information

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

Study locations

Chinese PLA General Hospital, Beijing, Beijing Municipality 100853 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.