Abstract：
Diabetic nephropathy represents a microvascular complication related to type 2 diabetes mellitus (T2DM) that ultimately causes end-stage renal disease. Our study aimed to evaluate the association of plasma type IV collagen with albuminuria status and to assess the clinical significance of plasma type IV collagen as a potential biomarker in the early stage of diabetic nephropathy. The study comprised 75 participants diagnosed with T2DM allocated equally (n=25) into three groups: (A) normal albuminuria levels, (B) microalbuminuria, and (C) macroalbuminuria, depending on their urine albumin-to-creatinine ratio. A comparative analysis was conducted between these groups and a control group (D, n=15). The enzyme-linked immunosorbent assay (ELISA) method was employed for measuring plasma type IV collagen levels. The results revealed that plasma type IV collagen levels were significantly higher in T2DM groups than in the control group. Moreover, diabetic patients without albuminuria had significantly higher plasma type IV collagen levels than the control group (p < 0.001). Furthermore, albuminuria levels among diabetic patient groups were significantly increased as albuminuria categories increased (p < 0.001). A significant positive correlation existed between plasma type IV collagen and glycated hemoglobin (HbA1c) levels in the macroalbuminuric diabetic group. Our study employed the receiver operating characteristic (ROC) curve analysis to determine plasma type IV collagen diagnostic utility in macroalbuminuria prediction. The ROC curve analysis revealed that type IV collagen can significantly determine macroalbuminuric patients at a cutoff value of 2.25 with sensitivity, specificity, positive predictive value, and negative predictive value of 68%, 100%, 100%, and 75.8%, respectively (p < 0.001). In conclusion, plasma type IV collagen levels might serve as a valuable predictor of albuminuria onset in patients with T2DM.
摘要：
糖尿病肾病代表与2型糖尿病（T2DM）相关的微血管并发症，最终导致终末期肾病。我们的研究旨在评估血浆IV型胶原与白蛋白尿状态的相关性，并评估血浆IV型胶原作为糖尿病肾病早期潜在生物标志物的临床意义。该研究包括75名被诊断为T2DM的参与者（n=25），平均分为三组：（A）正常白蛋白尿水平，(B)微量白蛋白尿,和（C）大量白蛋白尿，取决于他们的尿白蛋白与肌酐的比率。在这些组和对照组之间进行了比较分析（D，n=15)。采用酶联免疫吸附测定（ELISA）方法测量血浆IV型胶原水平。结果表明，T2DM组的血浆IV型胶原水平明显高于对照组。此外，无蛋白尿的糖尿病患者血浆IV型胶原水平明显高于对照组(p<0.001).此外，糖尿病患者组的白蛋白尿水平随着白蛋白尿类别的增加而显著增加(p<0.001).糖尿病患者血浆IV型胶原与糖化血红蛋白(HbA1c)水平呈显著正相关。我们的研究采用受试者工作特征（ROC）曲线分析来确定血浆IV型胶原在大量白蛋白尿预测中的诊断实用性。ROC曲线分析显示，IV型胶原可以在2.25的截止值处显著确定巨白蛋白尿患者，特异性，正预测值，阴性预测值为68%，100%,100%,75.8%,分别(p<0.001)。总之,血浆IV型胶原水平可能是T2DM患者蛋白尿发病的一个有价值的预测指标.
