| Background and ObjectiveType 2 Diabetes Mellitus(T2DM)is a common chronic metabolic disease.Long-term poor glycemic control can cause a variety of pathological changes in large blood vessels,microvascular and peripheral nerves.Recent studies have pointed out that the structural imbalance of gut microbiota may be involved in the occurrence and development of T2DM,and the glucose metabolism of patients can be improved by adjusting the structure of gut microbiota.Some kinds of traditional Chinese herbs can not only improve blood glucose but also participate in the regulation of gut microbiota,whereas their effect in T2DM patients still need to be determined and whether it can regulate the blood glucose of T2DM patients through changing the gut microbiota is still unclear.If the mechanism and the effect of such substances can be clarified,it will provide new therapeutic targets for the control of T2DM.Therefore,the purpose of this study was to explore the effect of taking Chinese herbs as tea(TCH tea)on improving blood glucose and gut microbiota of T2DM patients.A 12-week random controlled intervention trial was conducted and the internal relationship between the two aspects of blood glucose and gut microbiota was analyzed.The results are expected to provide reference for the adjuvant treatment of T2DM patients and the research about gut microbiota.MethodsThis study was a randomized controlled interventional trial using a convenient sampling method.A total of 90 community-dwelling patients with T2DM who met the inclusion and exclusion criteria were recruited from October 2018 to April 2019.After obtaining informed consent,the patients were randomly divided into control group(n=45)and intervention group(n=45).The control group maintained the conventional treatment and usual lifestyle,and the intervention group accepted additional intervention with TCH tea.The program of the intervention with TCH tea was determined based on literature data,expert advice and pre-experimental results.It included six substances:mulberry leaves,gynostemmas,astragalus membranaceus,corn silks,cortex lycll,and ophiopogon,and totaled 13 grams.Subjects in intervention group was instructed to drink 1000?1500 mL per day which used for making TCH tea,and the intervention period last for 12 weeks.A total of 83 patients completed the entire study,including 42 in the control group and 41 in the intervention group.Fasting plasma glucose(FPG)and glycated serum protein(GSP)levels were measured before the intervention,6 weeks and 12 weeks after the intervention,and the glycated hemoglobin(HbAlc),gut microbiota,blood lipid and liver and kidney functions were measured before and after the intervention.Patient's compliance in the intervention implementation,self-reported symptoms,and abnormal reactions were recorded.The results were analyzed through t test,repeated measures analysis of variance,chi-square test,rank sum test,and correlation analysis.Results1.Comparison of glucose metabolism indicators between and within groups(1)FPG:results of inter-group comparison showed that there was no significant difference in FPG levels between the two groups before intervention,at 6 weeks and 12 weeks after intervention(P>0.05),whereas the decrease in FPG at 12 weeks after intervention was significantly higher in the intervention group than that in the control group(P<0.05).Results of intra-group comparison showed that there was no significant difference in FPG in the two groups between 6 weeks or 12 weeks after intervention and before intervention(P>0.05).(2)GSP:results of inter-group comparison showed that there was no significant difference in GSP levels between the two groups before intervention,at 6 weeks and 12 weeks after intervention(P>0.05),whereas the decrease in GSP at 12 weeks after intervention was slightly higher in the intervention group than that in the control group,which was close to a significant difference(P=0.061).Results of intra-group comparison showed that the GSP levels in the two groups at 6 weeks or 12 weeks after intervention were lower than before intervention(P<0.01).(3)HbA1c:results of inter-group comparison showed that there was no significant difference in HbA1c levels between the two groups before intervention and 12 weeks after intervention(P>0.05),and there was no significant difference in the decrease in HbA1c between the two groups at 12 weeks after intervention(P>0.05).Results of intra-group comparison showed that there was no significant difference in HbAlc in the two groups between 12 weeks after intervention and before intervention(P>0.05).2.Comparison of gut microbiota between and within groups(1)Alpha diversity indexes:results of inter-group comparison showed that there was no significant difference in Ace,Chao1,Shannon and Simpson indexes between the two groups before and after intervention(P>0.05).Results of intra-group comparison showed that the Ace and Chao1 indexes in the intervention group were slightly higher after intervention than before intervention,and the values were close to significant differences(P=0.056,P=0.052).There was no significant difference in Shannon and Simpson indexes in the intervention group between after and before intervention(P>0.05),and there was no significant change in Ace,Chaol,Shannon,and Simpson indexes in the control group after intervention(P>0.05).(2)Gut microbiota composition:results of inter-group comparison showed that there was no significant difference in gut microbiota composition between the two groups before intervention(P>0.05).The abundance of actinobacteria after intervention was significantly higher in the intervention group than that in the control group(P<0.05).There was no significant difference in the abundance of Firmicutes,Bacteroidetes,and Proteobacteria between the two groups after intervention(P>0.05),and the abundance of Lachnospiraceae,Bifidobacteriaceae,Phascolarctobacterium and Bifidobacterium after intervention were significantly higher in the intervention group than those in the control group(P<0.05).Results of intra-group comparison showed that the abundance of Actinobacteria,Lachnospiraceae,Bifidobacteriaceae,Phascolarctobacterium and Bifidobacterium in the intervention group were significantly higher after intervention than before intervention(P<0.01),and there was no significant difference in gut microbiota composition in the control group between after and before intervention(P>0.05).3.Comparison of lipid profile between and within groupsResults of inter-group comparison showed that there were no significant difference in all parameters of blood lipid profile between the two groups before intervention(P>0.05).The total cholesterol(TC)levels after intervention was significantly lower in the intervention group than that in the control group(P<0.01).Results of intra-group comparison showed that the TC and low density lipoprotein(LDL)levels in the intervention group were significantly lower after intervention than before intervention,and the ratio of high density lipoprotein(HDL)and LDL(HDL/LDL)levels in the two groups were significantly higher after intervention than before intervention(P<0.05).4.Comparison of hepatorenal function indicators between and within groupsResults of inter-group comparison showed that there were no significant difference in the alanine aminotransferase(ALT),aspartate aminotransferase(AST),total protein(TP),albumin(ALB),total bilirubin(TBIL),alkaline phosphatase(ALP),blood urea nitrogen(BUN),creatinine(CREA)and uric acid(UA)between the two groups before intervention(P>0.05).The TP,ALB and CREA levels after intervention were significantly lower in the intervention group than those in the control group(P<0.01).There was no significant difference in other indicators levels between the two groups after intervention(P>0.05),and the levels of all indicators were within normal range.Results of intra-group comparison showed that the AST,TP,ALB,ALP and CREA levels in the intervention group were significantly lower after intervention than before(P<0.05),and there was no significant change in hepatorenal function indicators in the control group after intervention(P>0.05).5.Correlation analysis between gut microbiota abundance and glucose metabolism indicatorsThe abundance of lachnospiraceae was negatively correlated with FPG and GSP levels(P<0.05),and the abundance of Bifidobacterium was negatively correlated with FPG levels(P<0.05).6.Compliance,adverse reactions,and self-reported symptoms of the subjectsPatients in the intervention group had high compliance with TCH tea consumption.During the intervention,no hypoglycemia was reported.In the intervention group,one subject reported skin itching,three reported xerostomia,five vigor improvement,six defecation increase,five stool form improvement,five sleep quality improvement,and two significant improvement with blurred vision.In the control group,two subjects reported vigor improvement and three defecation increase.ConclusionsThe present study found that the 12-week TCH tea have the effect of improving blood glucose metabolism and increasing the abundance of the beneficial gut microbiota in T2DM patients,and the increase of beneficial bacteria abundance may be involved in the improvement of glucose metabolism indicators.In addition,T2DM patients have high acceptance,good compliance,and safe outcome with TCH tea consumption,and some T2DM patients have improvement in blood lipid level and health problems such as defecation,sleep,and vision.Longer intervention period may produce more obvious effects.The results of this study provide reference for the research in adjuvant therapy and gut microbiota mechanism in T2DM patients. |
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