Study On The Effect Of Berberine Hydrochloride Combined With Metformin On Hypoglycemic Effect And Islet Function In Patients With T2DM

Objective: To investigate the hypoglycemic effect of berberine hydrochloride(BBR)combined with metformin(Met)in patients with type 2 diabetes mellitus(T2DM),and the effect on secretion function of islet ?-cell and insulin resistance(IR).Methods: A total of 120 T2DM patients with Met alone stable treatment of 1000mg-2000mg/d for more than 3 months and glycated hemoglobin(Hb A1c)of 7-10% were selected as the study subjects.They were randomly divided into the treatment group(60 cases,1 case of withdrawal and 3 cases of shedding)and the control group(60 cases,1 case of withdrawal and 7 cases of shedding).The original Met dose was maintained in all patients,BBR was added to the treatment group and an equivalent dose of placebo was added to the control group.After 24 weeks,the difference in body mass index(BMI),fasting blood glucose(FPG),1-hour postprandial blood glucose(1h PG),2-hour postprandial blood glucose(2h PG),Hb A1 c,Cholesterol(TC),Triglyceride(TG),low density lipoprotein(LDL-C),high density lipoprotein(HDL-C),Fasting C peptide(CP),fasting insulin(FINS),1-hour postprandial insulin(1h INS),2-hour postprandial insulin(2h INS),islet ? cell function index(HOMA-?),area under the insulin curve [AUC(INS)],insulin resistance index(HOMA-IR)and inflammatory factor(CRP,TNF-?,IL-6)levels before and after treatment were compared between the two groups.SPSS 22.0 software was used for statistical analysis of the data.Results: 1.Comparison of metabolic indicators between the two groups: After 24 weeks of treatment,FPG,2h PG,Hb Alc,BMI,TG,TC,and LDL-C in the two groups of patients were significantly decreased,and the decrease degree of FPG,2h PG,Hb Alc,BMI and TG in the treatment group was more significant(P <0.05).HDL-C increased in both groups(P <0.05),but the difference between the two groups was not statistically significant(P> 0.05);There was no significant improvement of 1h PG before and after treatment in the two groups(P> 0.05).In the treatment group,FPG,2h PG and Hb Alc decreased by 1.59 mmol / L,1.11 mmol / L,and 0.65% respectively,indicating a good hypoglycemic effect.2.Comparison of islet function indexes between the two groups: After 24 weeks of treatment,the FINS,CP,and HOMA-IR of the two groups decreased significantly,while the 2h INS,HOMA-?,and AUC(INS)increased significantly,and the improvement degree of the treatment group was better(P <0.05);There was no significant increase in 1h INS in both groups compared with before treatment(P> 0.05).The treatment group showed a better effect on the improvement of insulin secretion in late phase.3.Comparison of inflammatory indicators between the two groups: After 24 weeks of treatment,CRP and TNF-? were significantly decreased in both groups,and the improvement in the treatment group was better(P <0.05).There was no significant change in IL-6 in the control group,and there was a statistically significant decrease in IL-6 in the treatment group(P <0.05).4.Safety analysis: During the study period,no hypoglycemia events occurred in the two groups,and the adverse reactions were mainly gastrointestinal abnormalities,mainly manifested as nausea,vomiting,abdominal pain,diarrhea etc.The incidence rate of the treatment group was 8.8%,and that of control group was 13.2%.Symptoms could be relieved by adjusting the dose of the drug,and there was no statistical difference in the incidence of adverse reactions between the two groups(P> 0.05).Conclusion: BBR combined with Met in the treatment of T2DM has good safety,no hypoglycemia reaction,and low gastrointestinal adverse reactions.The overall efficacy is better than that of Met single drug treatment,which can more effectively improve BMI,blood glucose and blood lipids,promote the recovery of islet ? cell function,enhance late Phase insulin secretion ability,improve IR,and reduce serum CRP,TNF-? and IL-6 levels.