| BackgroudIn recent years, the incidence of type2diabetes has been increasing gradually, and it has become a major public health problem. As a chronic metabolic disease, type2diabetes is a metabolic disorder characterized by hyperinsulinemia and insulin resistance. Therefore, strategies aiming to improve insulin sensitivity and amerolate insulin resistance will benefit type2diabetic patients. Recently, there have been many papers published showed that the level of serum chrome was decreased obviously in type2diabetic patients, compared with non-diabetic patients. Moreover, the decreased level of serum chrome correlated with glucose metabolism disorder positively, and strategic aiming to increase serum chrome will result in a better therapeutic effect. Tian mai xiao ke pian integrates chromium picolinate with traditional Chinese medicine, providing a new drug in the treatment of type2diabetic patients. However, clinical data of Tian mai xiao ke pian combined with metformin in treatment of newly diagnosed type2diabetic patients is deficient.ObjectiveTo evaluate the therapeutic effectiveness and Safety of tian mai xiao ke pian combined with metformin in newly diagnosed type2diabetic patients.MethodsIn this randomized, parallel-controlled study,150newly diagnosed patients with type2diabetes were randomly assigned to two groups. Patients in treatment group received Tian mai xiao ke pian combined with metformin, while patients in the control group received metformin only, and then followed-up for12weeks. All patients are required to receive laboratory examination before and after the treatment, including glycosylated hemoglobin A1c(HbA1c), blood sugar, insulin, C-peptide, weight, heart rate, blood pressure, blood lipid level, et al. Adverse reactions were also recorded. Statistical procedures were performed with the statistical package PASW18.0. Significance is defined as a two tailed P<0.05.ResultsNo significant difference was found at baseline between the two groups (P>0.05).①The level of HbA1c, fasting blood glucose (FBG) and2h-postprandial plasma glucose (2hPPG) were significantly lower in treatment group than control group (P<0.01). The target rate of HbAlc in treatment group is higher.②The level of fasting insulin (FINS) and2-hour postprandial insulin (2hPINS) were much lower in treatment group as compared with control group (P<0.05).③The level of fasting C-peptide and two hours after meal C-peptide were significantly higher in treatment group than control group (P<0.01or P<0.05).④The decrease of HOMA insulin resistance index (HOMA-IR) was more significantly in treatment group than control group (P<0.05).⑤The decrease of body mass index (BMI) was more significantly in treatment group than control group (P<0.05).⑥Total cholesterol (Cho), triglyceride (TG), low density lipoprotein cholesterol (LDL-c) decreased significantly in treatment group (P<0.01), and high density lipoprotein cholesterol (HDL-c) increased more significantly in treatment group than control group(P<0.01).⑦Systolic blood pressure (SBP), diastolic blood pressure (DBP) of treatment group and SBP of control group decreased significantly (P<0.01or P<0.05), while DBP of treatment group decreased more significantly than control group(P<0.05).⑧There was no definitive hypoglycemia occurred in both groups. The most common adverse reactions reported were gastrointestinal symptoms which were usually mild to moderate and spontaneous remission with time. There were no differences in the incidence of gastrointestinal adverse reactions between both groups.ConclusionIn conclusion, treatment using Tian mai xiao ke pian combined with metformin is effective for type2diabetic patients, resulting in a decreased level of FBG,2hPPG, blood lipids, blood pressure and BMI. Namely, it brought out an improved insulin sensitivity without increased risk of hypoglycemia and other adverse events. Tian mai xiao ke pian can be viewed as a new therapeutic choice for those newly diagnosed diabetic patients. |
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