Clinical trial NCT03865914: Correlation Study Between Clinical Phenotype and Pathology of Type 2 Diabetic Nephropathy
Official title: Correlation Study Between Clinical Phenotype and Pathology of Type 2 Diabetic Nephropathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Kidney Disease
Keywords: Diabetic kidney disease (DKD)
Diabetic nephropathy（DN)
non-diabetic renal diseases（ NDRD)
Clinical-pathological correlations
differential diagnosis
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Science & Technology Commission
name: China-Japan Friendship Hospital
name: Beijing Friendship Hospital
name: Beijing Hospital
name: Fourth Medical Center of PLA General Hospital
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Third Medical Center of PLA General Hospital
name: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
name: The First Affiliated Hospital of Dalian Medical University
name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Dongzhimen Hospital, Beijing
name: Shanghai University of Traditional Chinese Medicine
First posted: 2019-03-07
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: change in eGFR and urine protein from baseline
timeFrame: 24months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Xiangmei Chen, MD.&Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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. 2023 Apr;29(4):308-315. doi: 10.1007/s11655-022-3520-0. Epub 2022 Jun 9.