BACKGROUND Prediabetes mellitus(PDM)is receiving increasing attention as a precursor to type 2 diabetes mellitus.Lifestyle and traditional Chinese medicine(TCM)inter-ventions are effective for PDM prevention and treat...BACKGROUND Prediabetes mellitus(PDM)is receiving increasing attention as a precursor to type 2 diabetes mellitus.Lifestyle and traditional Chinese medicine(TCM)inter-ventions are effective for PDM prevention and treatment.Therefore,we con-ducted a preliminary investigation and an exploratory randomised controlled trial to assess the effects of a combined lifestyle and TCM intervention on PDM indicators.AIM To study the effectiveness of Xiaokeqing granules(XQG)and lifestyle inter-ventions in PDM participants while using metabolomics to identify potential markers.METHODS 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 per 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),gly-cated haemoglobin A1c,fasting insulin,homeostasis model assessment-insulin resistance levels,and serum metabolomics characteristics were compared via liquid chromatography-tandem mass spectrometry analysis.RESULTS There were significant differences in 2hPG between the two groups(P<0.05)in the intention-to-treat analysis and per-protocol analysis.The intervention method used in this study was safe(P>0.05).Groenlandicine,kaempferol,isomangiferin,etc.,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.HTR1A,HTR2C,SLC6A4,etc.,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.CONCLUSION This pilot study provides evidence that a combined XQG and lifestyle intervention can improve 2hPG in par-ticipants with PDM.The mechanism of action is related to multiple constituents,targets and pathways.展开更多
基金Supported by the Open Bidding for Selecting the Best Candidates for Xin’an Medicine and the Modernization of Traditional Chinese Medicine of IHM,No.2023CXMMTCM024 and No.2023CXMMTCM003the Anhui University Collaborative Innovation Project,No.GXXT-2020-025+2 种基金the Scientific Research Project of Health and Wellness in Anhui Province,No.AHWJ2023BAc10002the Anhui Province New Era Education Quality Project,No.2023gjxslt014and the Clinical and Translational Research Project of Anhui Province,No.202427b10020046.
文摘BACKGROUND Prediabetes mellitus(PDM)is receiving increasing attention as a precursor to type 2 diabetes mellitus.Lifestyle and traditional Chinese medicine(TCM)inter-ventions are effective for PDM prevention and treatment.Therefore,we con-ducted a preliminary investigation and an exploratory randomised controlled trial to assess the effects of a combined lifestyle and TCM intervention on PDM indicators.AIM To study the effectiveness of Xiaokeqing granules(XQG)and lifestyle inter-ventions in PDM participants while using metabolomics to identify potential markers.METHODS 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 per 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),gly-cated haemoglobin A1c,fasting insulin,homeostasis model assessment-insulin resistance levels,and serum metabolomics characteristics were compared via liquid chromatography-tandem mass spectrometry analysis.RESULTS There were significant differences in 2hPG between the two groups(P<0.05)in the intention-to-treat analysis and per-protocol analysis.The intervention method used in this study was safe(P>0.05).Groenlandicine,kaempferol,isomangiferin,etc.,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.HTR1A,HTR2C,SLC6A4,etc.,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.CONCLUSION This pilot study provides evidence that a combined XQG and lifestyle intervention can improve 2hPG in par-ticipants with PDM.The mechanism of action is related to multiple constituents,targets and pathways.