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

Recruiting

• Conditions: Diabetic Kidney Disease

• Registration Number: NCT03865914
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-30
• Study First Submitted: 2019-03-02
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-07
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-31
• Primary Completion: 2027-11-30
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in eGFR and urine protein from baseline	24months	eGFR is calculated using the CKD-EPI formula, involving gender, age, and serum creatinine.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China