Correlation Study Between Clinical Phenotype and Pathology of Type 2 Diabetic Nephropathy
1 other identifier
observational
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 30, 2017
CompletedFirst Submitted
Initial submission to the registry
March 2, 2019
CompletedFirst Posted
Study publicly available on registry
March 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
March 31, 2022
March 1, 2022
10 years
March 2, 2019
March 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in eGFR and urine protein from baseline
eGFR is calculated using the CKD-EPI formula, involving gender, age, and serum creatinine.
24months
Study Arms (1)
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.
Eligibility Criteria
The aim of this study is 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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese PLA General Hospitallead
- Beijing Municipal Science & Technology Commissioncollaborator
- China-Japan Friendship Hospitalcollaborator
- Beijing Friendship Hospitalcollaborator
- Beijing Hospitalcollaborator
- Fourth Medical Center of PLA General Hospitalcollaborator
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical Schoolcollaborator
- Third Medical Center of PLA General Hospitalcollaborator
- Shanghai Jiao Tong University Affiliated Sixth People's Hospitalcollaborator
- The First Affiliated Hospital of Dalian Medical Universitycollaborator
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical Universitycollaborator
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicinecollaborator
- Guang'anmen Hospital of China Academy of Chinese Medical Sciencescollaborator
- Dongzhimen Hospital, Beijingcollaborator
- Shanghai University of Traditional Chinese Medicinecollaborator
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Related Publications (4)
Dong Z, Wang X, Pan S, Weng T, Chen X, Jiang S, Li Y, Wang Z, Cao X, Wang Q, Chen P, Jiang L, Cai G, Zhang L, Wang Y, Yang J, He Y, Lin H, Wu J, Tang L, Zhou J, Li S, Li Z, Fu Y, Yu X, Geng Y, Zhang Y, Wang L, Xu M, Chen X. A multimodal transformer system for noninvasive diabetic nephropathy diagnosis via retinal imaging. NPJ Digit Med. 2025 Jan 24;8(1):50. doi: 10.1038/s41746-024-01393-1.
PMID: 39856403DERIVEDWang Q, Cheng H, Jiang S, Zhang L, Liu X, Chen P, Liu J, Li Y, Liu X, Wang L, Li Z, Cai G, Chen X, Dong Z. The relationship between diabetic retinopathy and diabetic nephropathy in type 2 diabetes. Front Endocrinol (Lausanne). 2024 Jan 26;15:1292412. doi: 10.3389/fendo.2024.1292412. eCollection 2024.
PMID: 38344659DERIVEDZhang W, Liu X, Dong Z, Wang Q, Pei Z, Chen Y, Zheng Y, Wang Y, Chen P, Feng Z, Sun X, Cai G, Chen X. New Diagnostic Model for the Differentiation of Diabetic Nephropathy From Non-Diabetic Nephropathy in Chinese Patients. Front Endocrinol (Lausanne). 2022 Jun 30;13:913021. doi: 10.3389/fendo.2022.913021. eCollection 2022.
PMID: 35846333DERIVEDQu YL, Dong ZY, Cheng HM, Liu Q, Wang Q, Yang HT, Mao YH, Li JJ, Liu HF, Geng YQ, Huang W, Liu WH, Xie HD, Peng F, Li S, Jiang SS, Li WZ, Duan SW, Feng Z, Zhang WG, Liu YN, Tian JZ, Chen XM. Evaluation of Renal Impairment in Patients with Diabetic Kidney Disease by Integrated Chinese and Western Medicine. Chin J Integr Med. 2023 Apr;29(4):308-315. doi: 10.1007/s11655-022-3520-0. Epub 2022 Jun 9.
PMID: 35679002DERIVED
Biospecimen
Blood, urine, kidney tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiangmei Chen, MD.&Ph.D
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor,Chief physician,Academician of Chinese Academy of Engineering
Study Record Dates
First Submitted
March 2, 2019
First Posted
March 7, 2019
Study Start
November 30, 2017
Primary Completion (Estimated)
November 30, 2027
Study Completion (Estimated)
December 31, 2030
Last Updated
March 31, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share
The test has not been completed.