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Correlation Study Between Clinical Phenotype and Pathology of Type 2 Diabetic Nephropathy
NCT03865914 · Chinese PLA General Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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.
Eligibility criteria
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
Enrollment target: 2000 participants
Age groups: adult, older_adult
Timeline
Starts: 2017-11-30
Estimated completion: 2030-12-31
Last updated: 2022-03-31
Primary outcomes
- • change in eGFR and urine protein from baseline (24months)
Sponsor
Chinese PLA General Hospital · other
With: Beijing Municipal Science & Technology Commission, China-Japan Friendship Hospital, Beijing Friendship Hospital, Beijing Hospital, Fourth Medical Center of PLA General Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Third Medical Center of Chinese PLA General Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, The First Affiliated Hospital of Dalian Medical University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Dongzhimen Hospital, Beijing, Shanghai University of Traditional Chinese Medicine
Contacts & investigators
ContactXiangmei Chen, MD.&Ph.D · contact · xmchen301@126.com · +86 010 66935462
ContactZheyi Dong, MD.&Ph.D · contact · shengdai26@163.com · +86 010 66935462
InvestigatorXiangmei Chen, MD.&Ph.D · principal_investigator, Chinese PLA General Hospital
All locations (1)
Chinese PLA General HospitalRecruiting
Beijing, Beijing Municipality, China