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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 30, 2027

Arms, Groups and Cohorts

  • Type 2 diabetic nephropathy
    • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese PLA General Hospital
  • Collaborator
    • Beijing Municipal Science & Technology Commission
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xiangmei Chen, Professor,Chief physician,Academician of Chinese Academy of Engineering – Chinese PLA General Hospital
  • Overall Official(s)
    • Xiangmei Chen, MD.&Ph.D, Principal Investigator, Chinese PLA General Hospital
  • Overall Contact(s)
    • Xiangmei Chen, MD.&Ph.D, +86 010 66935462, xmchen301@126.com

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