A Non-Invasive Predictive Model for Identifying Non-Diabetic Kidney Disease in Type 2 Diabetes Mellitus: Development and Multicenter Validation

 

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A Non-Invasive Predictive Model for Identifying Non-Diabetic Kidney Disease in Type 2 Diabetes Mellitus: Development and Multicenter Validation

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yuyan
yang
Pinning Feng fengpn@sysu.edu.cn The First Affiliated Hospital of Sun Yat-sen University Department of Laboratory Medicine Guangzhou China -
Xianlian Deng dengxianlian1994@163.com Shenzhen Mindray Biomedical Electronics Co., LTD. IVD Division shenzhen China -
Youlin Liu liuyoulin@mindray.com Shenzhen Mindray Biomedical Electronics Co., LTD. IVD Division shenzhen China -
Peng Zhang nfyyzp@126.com Nanfang Hospital, Southern Medical University Department of Laboratory Medicine guangzhou China -
Feng Hu jfjhf1504@126.com Shenzhen third People’s Hospital Department of Nephrology shenzhen China -
yuyan yang ty2436@163.com Shenzhen third People’s Hospital Department of Nephrology shenzhen China *
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Diabetes mellitus (DM), especially type 2 diabetes mellitus (T2DM), seriously threatens human health. Diabetic renal injury is divided into diabetic kidney disease (DKD) and non-diabetic kidney disease (NDKD) by etiology, with significant differences in treatment and prognosis; thus, their differential diagnosis is key for clinical practice. This study aimed to construct a non-invasive, simple, and efficient predictive model for T2DM patients with renal injury before renal biopsy to assist DKD/NDKD differentiation and provide a scientific basis for timely and precise clinical diagnosis and treatment.

Patients with T2DM complicated with renal injury were enrolled. Retrospective analysis was conducted on 117 confirmed T2DM patients from Hospital A (Jan 2017–May 2022), grouped by renal biopsy results. Medical history, physical signs, and laboratory data were collected; predictive factors were screened via univariate and multivariate regression to build the differential diagnostic model. For independent internal/external validation: Validation Cohort 1 (52 cases, Hospital A, Jun 2022–Sep 2023), Validation Cohort 2 (78 cases, Hospital B, Jul–Sep 2023), Validation Cohort 3 (168 cases, Hospital C, May 2018–Oct 2023). Only DKD/NDKD patients were included (low proportion and complex mechanism of DKD+NDKD [Mix] group). Model discriminative ability, calibration, goodness-of-fit, and clinical utility were evaluated via area under ROC curve (AUC), calibration curve, and decision curve analysis (DCA).

Of 415 T2DM patients, 130 (31.33%) were DKD, 233 (56.15%) NDKD, 52 (12.53%) Mix. The RICH model (for DKD/NDKD differentiation in T2DM with renal injury) included variables: RBC, IgA, cystatin C-based estimated glomerular filtration rate (eGFR_2), and HbA1c. AUCs were 0.847 (0.766–0.929) (modeling cohort), 0.755 (0.611–0.899) (Cohort 1), 0.754 (0.654–0.874) (Cohort 2), 0.768 (0.665–0.845) (Cohort 3). Calibration curves showed good consistency between predicted and actual probabilities (all Hosmer-Lemeshow test P>0.05). DCA indicated high clinical net benefit at threshold probability 0.10–0.80, with theoretical 42.05% reduction in renal biopsy rate.

Based on objective laboratory indicators from three centers, the RICH model was constructed and validated for DKD/NDKD differentiation in adult T2DM with renal injury. Higher eGFR_2, IgA, RBC, and lower HbA1c are key for NDKD identification. This model is highly objective, straightforward to operate, and possesses both high accuracy and strong multicentre applicability. It aids in reducing unnecessary renal biopsies and enhances care for patients who cannot undergo the procedure.

Kewords