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

Обзор

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.

Первичные конечные точки

• change in eGFR and urine protein from baseline [Срок оценки: 24months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Chinese PLA General Hospital — Пекин

Публикации

• Wang Q, Zhou S, Niu Y, Li C, Lyu Q, Chen P, Zhang X, Xie L, Shen W, Wang Y, Cao X, Cai G, Chen X, Wang H, Dong Z. Clinical utility of BOLD-MRI in accurate diagnosis and prognostic evaluation of diabetic nephropathy: a prospective renal biopsy-based cohort study. Insights Imaging. 2026 Apr 20;17(1):106. doi: 10.1186/s13244-026-02274-9. PMID 42008071
• 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 39856403
• Wang 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 38344659
• 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. PMID 35846333
• 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. PMID 35679002

Идентификаторы

NCT: NCT03865914 · S2017-133-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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