Zhao Jin-Dong, Guo Meng-Zhu, Zhang Yi, Zhu Shao-Hua, Wang Ya-Ting, Zhang Yan-Ping, Liu Xin, Cheng Si, Wang Fei, Xu Qi, Ruan Nuo-Bing, Fang Zhao-Hui
Department of Endocrinology, The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei 230031, Anhui Province, China.
Center for Xin'an Medicine and Modernization of Traditional Chinese Medicine of IHM, The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei 230031, Anhui Province, China.
World J Diabetes. 2025 Jul 15;16(7):105219. doi: 10.4239/wjd.v16.i7.105219.
Prediabetes mellitus (PDM) is receiving increasing attention as a precursor to type 2 diabetes mellitus. Lifestyle and traditional Chinese medicine (TCM) interventions are effective for PDM prevention and treatment. Therefore, we conducted a preliminary investigation and an exploratory randomised controlled trial to assess the effects of a combined lifestyle and TCM intervention on PDM indicators.
To study the effectiveness of Xiaokeqing granules (XQG) and lifestyle interventions in PDM participants while using metabolomics to identify potential markers.
Forty PDM participants with yin deficiency syndrome with excessive heat were recruited and randomly allocated to the control (Con) group or the XQG group (20 group). The Con group underwent lifestyle interventions, whereas the XQG group underwent lifestyle and XQG interventions. The follow-up duration was 2 months. Fasting blood glucose, 2-hour postprandial glucose (2hPG), glycated haemoglobin A1c, fasting insulin, homeostasis model assessment-insulin resistance levels, and serum metabolomics characteristics were compared liquid chromatography-tandem mass spectrometry analysis.
There were significant differences in 2hPG between the two groups ( < 0.05) in the intention-to-treat analysis and -protocol analysis. The intervention method used in this study was safe ( > 0.05). Groenlandicine, kaempferol, isomangiferin, , are the XQG constituents absorbed in the blood. N-Nervonoyl methionine and 5-hydroxy-L-tryptophan are core potential metabolomic biomarkers for the effectiveness of XQG and lifestyle interventions. , , , , are the core targets of XQG and lifestyle interventions, as well as the reason for their clinical efficacy. Possible mechanistic pathways include tryptophan metabolism, pantothenate and certificate of analysis biosynthesis, lysine degradation and biosynthesis of cofactors.
This pilot study provides evidence that a combined XQG and lifestyle intervention can improve 2hPG in participants with PDM. The mechanism of action is related to multiple constituents, targets and pathways.
糖尿病前期（PDM）作为2型糖尿病的前驱疾病正受到越来越多的关注。生活方式和中医干预对PDM的防治有效。因此，我们进行了一项初步调查和一项探索性随机对照试验，以评估生活方式与中医联合干预对PDM指标的影响。
研究消渴清颗粒（XQG）和生活方式干预对PDM参与者的有效性，同时使用代谢组学来识别潜在标志物。
招募40例阴虚热盛证的PDM参与者，随机分为对照组（Con组）或XQG组（每组20例）。Con组进行生活方式干预，而XQG组进行生活方式和XQG干预。随访时间为2个月。通过液相色谱-串联质谱分析比较空腹血糖、餐后2小时血糖（2hPG）、糖化血红蛋白A1c、空腹胰岛素、稳态模型评估-胰岛素抵抗水平和血清代谢组学特征。
在意向性分析和符合方案分析中，两组间2hPG有显著差异（P<0.05）。本研究使用的干预方法是安全的（P>0.05）。格陵兰icine（groenlandicine）、山奈酚、异芒果苷等是XQG中被血液吸收的成分。N-神经酰基蛋氨酸和5-羟基-L-色氨酸是XQG和生活方式干预有效性的核心潜在代谢组学生物标志物。丝氨酸、苏氨酸、缬氨酸、亮氨酸、异亮氨酸是XQG和生活方式干预的核心靶点，也是其临床疗效的原因。可能的作用机制途径包括色氨酸代谢、泛酸和辅酶A生物合成、赖氨酸降解以及辅因子生物合成。
这项初步研究提供了证据，表明XQG与生活方式联合干预可改善PDM参与者的2hPG。作用机制与多种成分、靶点和途径有关。
