Wang Kai, Qian Qi, Bian Chencheng, Sheng Pei, Zhu Lin, Teng Shichao, An Xiaofei
Department of Endocrinology, Affiliated Hospital of Nanjing University of Chinese Medicine, 155 Han-Zhong Road, Nanjing, 210029, China.
Department of Physical Examination Center, Affiliated Hospital of Nanjing University of Chinese Medicine, 155 Han-Zhong Road, Nanjing, 210029, China.
Diabetes Ther. 2025 Jan;16(1):89-102. doi: 10.1007/s13300-024-01667-7. Epub 2024 Nov 18.
Type 2 diabetes mellitus (T2DM) is a highly heterogeneous disease with a varying risk of complications. The recent novel subgroup classification using cluster analysis contributed to the risk evaluation of diabetic complications. However, whether the subgroup classification strategy could be adopted to predict the risk of onset and progression of diabetic kidney disease (DKD) in Chinese individuals with T2DM remains to be elucidated.
In this retrospective study, 612 Chinese patients with T2DM were enrolled, and the median follow-up time was 3.5 years. The T2DM subgroups were categorized by a two-step cluster analysis based on five parameters, including age at onset of diabetes, body mass index (BMI), glycosylated hemoglobin (HbA1c), homeostasis model assessment 2 of insulin resistance (HOMA2-IR), and homeostasis model assessment 2 of β-cell function (HOMA2-β). Clinical characteristics across subgroups were compared using t-tests and chi-square tests. Furthermore, multivariate logistic regression models were adopted to assess the risk of albuminuria progression and renal function decline among different subgroups.
The cohort was categorized into four groups: severe insulin-deficient diabetes (SIDD), with 146 patients (23.9%); mild insulin resistance (MIRD), with 81 patients (13.2%); moderate glycemic control diabetes (MGCD), with 211 patients (34.5%); and moderate weight insulin deficiency diabetes (MWIDD), with 174 patients (28.4%). The MIRD group exhibited an increased risk of progression from non-albuminuria to albuminuria as compared with the MWIDD group, with an adjusted odds ratio (OR) and 95% confidence interval (CI) of 2.92 (1.06, 8.04). The SIDD group had a higher risk of progression from micro-albuminuria to macro-albuminuria as compared with the MGCD group, with an adjusted OR and 95% CI of 3.39 (1.01, 11.41). There was no significant difference in the glomerular filtration rate (GFR) decline among all groups.
The present study offered the first evidence for risk evaluation of the development of DKD in the novel cluster-based T2DM Chinese subgroups. It suggested that the MIRD subgroup had a higher risk of DKD onset than the MWIDD subgroup. Meanwhile, the SIDD subgroup showed a higher risk of progression of albuminuria than the MGCD subgroup. This novel classification system could be effective in predicting the risk of DKD in Chinese patients with T2DM, which could facilitate the implementation of personalized therapeutic strategies.
This study was registered in the Chinese Clinical Trial Registry (ChiCTR2300077183).
2型糖尿病(T2DM)是一种高度异质性疾病,并发症风险各异。最近利用聚类分析进行的新型亚组分类有助于糖尿病并发症的风险评估。然而,在中国T2DM患者中,这种亚组分类策略能否用于预测糖尿病肾病(DKD)的发病和进展风险仍有待阐明。
在这项回顾性研究中,纳入了612例中国T2DM患者,中位随访时间为3.5年。基于糖尿病发病年龄、体重指数(BMI)、糖化血红蛋白(HbA1c)、胰岛素抵抗稳态模型评估2(HOMA2-IR)和β细胞功能稳态模型评估2(HOMA2-β)这五个参数,通过两步聚类分析对T2DM亚组进行分类。采用t检验和卡方检验比较各亚组的临床特征。此外,采用多因素逻辑回归模型评估不同亚组中蛋白尿进展和肾功能下降的风险。
该队列被分为四组:严重胰岛素缺乏型糖尿病(SIDD),146例患者(23.9%);轻度胰岛素抵抗型糖尿病(MIRD),81例患者(13.2%);中度血糖控制型糖尿病(MGCD),211例患者(34.5%);中度体重胰岛素缺乏型糖尿病(MWIDD),174例患者(28.4%)。与MWIDD组相比,MIRD组从非蛋白尿进展为蛋白尿的风险增加,调整后的优势比(OR)和95%置信区间(CI)为2.92(1.06,8.04)。与MGCD组相比,SIDD组从微量白蛋白尿进展为大量白蛋白尿的风险更高,调整后的OR和95%CI为3.39(1.01,11.41)。所有组间肾小球滤过率(GFR)下降无显著差异。
本研究为基于新型聚类的中国T2DM亚组中DKD发生风险评估提供了首个证据。表明MIRD亚组发生DKD的风险高于MWIDD亚组。同时,SIDD亚组蛋白尿进展风险高于MGCD亚组。这种新型分类系统可有效预测中国T2DM患者的DKD风险,有助于实施个性化治疗策略。
本研究在中国临床试验注册中心注册(ChiCTR2300077183)。