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

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 Overview

• Status: Recruiting
• Conditions: Diabetic Kidney Disease

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Xiangmei Chen, MD.&Ph.D; Phone Number: +86 010 66935462; Email: xmchen301@126.com
• Study Contact Backup: Name: Zheyi Dong, MD.&Ph.D; Phone Number: +86 010 66935462; Email: shengdai26@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Xiangmei Chen, MD.&Ph.D; Phone Number: +86 010 66935462; Email: xmchen301@126.com
      • Contact: Qian Wang, MM; Phone Number: +86 010 66935462; Email: 794317255@qq.com
      • Principal Investigator: Xiangmei Chen, MD.&Ph.D
      • Sub-Investigator: Zheyi Dong, MD.&Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: Beijing Friendship Hospital; Guang'anmen Hospital of China Academy of Chinese Medical Sciences; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Beijing Municipal Science & Technology Commission; Beijing Hospital; China-Japan Friendship Hospital; First Teaching Hospital of Tianjin University of Traditional Chinese Medicine; Shanghai University of Traditional Chinese Medicine; Daping Hospital and the Research Institute of Surgery of the Third Military Medical University; The First Affiliated Hospital of Dalian Medical University; Shanghai Jiao Tong University Affiliated Sixth People's Hospital; Fourth Medical Center of PLA General Hospital; Third Medical Center of PLA General Hospital; Dongzhimen Hospital, Beijing University of Chinese Medicine
• Investigators: Principal Investigator: Xiangmei Chen, MD.&Ph.D, Chinese PLA General Hospital

Publications and helpful links

General Publications

• Zhang 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.
• Qu 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. 2022 Jun 9. doi: 10.1007/s11655-022-3520-0. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Anticipated): November 30, 2027
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: March 2, 2019
• First Submitted That Met QC Criteria: March 5, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: differential diagnosis; Diabetic kidney disease (DKD); Diabetic nephropathy（DN); non-diabetic renal diseases（ NDRD); Clinical-pathological correlations
• Additional Relevant MeSH Terms: Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Kidney Diseases; Diabetic Nephropathies
• Other Study ID Numbers: S2017-133-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The test has not been completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No