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

NCT03865914 · tracked via the Priya Life Science China tracker

Sponsor

Chinese PLA General Hospital

Phase

Observational

Started

2017-11-30

Last updated

2022-03-31

Condition(s) studied

Diabetic Kidney Disease

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
Chinese PLA General Hospital	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03865914 on ClinicalTrials.gov ↗ ← All trials in China