| 1.BackgroundType 2 diabetes is a serious human health hazards,and it has become a serious public health problem.Type 2 diabetes is a complex multi-gene genetic diseases,which caused by genetic and environmental factors, including food and calorie unreasonable intake.Diet therapy is the basic treatment of type 2 diabetes therapy.Other treatment must base on it.Currently,China's dietary standards is a reference to the American Diabetes Association(ADA) in accordance with the Western diet composition and metabolic status,which is not entirely suited to the Chinese metabolism.Diet has a history of several thousand years in China.According to Chinese medicine theory,the human body has different physique.Based on the patient's physique to choose the appropriate food is the core of Chinese medicine diet therapy.It is also the key to improve efficacy of diet control.This study is based on Chinese medicine.Four categories of staple foods and Non-staple food are classified by herbal nature and taste vegetables.The modern method of calculation of total heat will be integrated into the Chinese medicine theory.We will invent the diet control and menus for intoexcess heat and deficiency-cold syndrome.The establishment of Chinese medicine diet control of type 2 diabetes is very important to improve clinical efficacy for Type 2 diabetes.2.PurposeIt is arandomized,controlled,prospective study on the diet control of type 2 diabetes established according to Chinese medicine theory and the basic diet control.It will help us to form a diet control program that suit the Chinese peoples physique and diet habits.It is not only confirmed the scientific of traditional Chinese medicine diet program of type 2 diabetes,and make it affordable to the public.It helps to form a wide range of applications,and simple program of diet,which is expected to be used by high-risk people.3.Methods3.1 Subjects:144 outpatients from the Changping Chinese medicine hospital and Pinggu Chinese medicine hospitals who have been diagnosed as type 2 diabetes.3.2 Case inclusion criteria:Diabetes patients meet the diagnostic criteria of TCM,belonging to intoexcess heat and deficiency-cold syndrome.People in line with the WHO diagnostic criteria for diabetes, along with the following conditions①type 2 diabetes,and fasting blood glucose≤13mmol/l,blood glucose two hours after meal≤16mmol /l;②30-70 years old.People have signed the informed consent.3.3 Sub-group:We used randomized,controlled,prospective study method.144 cases of type 2 diabetes in line with case inclusion criteria from Changping Chinese medicine hospital and PingguChinese medicine hospital were randomly divided into study group 72 cases(36 cases of heat group,36 cases of cold group) and 72 cases of the control group(36 cases of heat group,36 cases of cold group).3.4 Treatment:All subjects recieved the health education on the principles of the basic diet(guidance from a doctor).During the observation,the original dose of Western medicine for hypoglycemic remained unchanged.Study group patients physical fitness were determined by the physician.They were given the diet program guidance based on the theory of Chinese medicine(guidance from dieticians).The deficiency-cold syndrome group will be given the food that is warm and reinforcing deficiency,using the method of reinforcing deficiency and warming the middle jiao expeling cold.The intoexcess heat syndrome group were given the food that is cool,using the method of removing stagnation,fu-nnblocking and clearing heat.The control group were given the basic diet therapy program guidance(guidance from dieticians) that control patients of the total calories without considering the nature of food.3.5 outcome measures:①efficacy indicators:fasting and two hours of postprandial venous blood glucose,glycosylated hemoglobin,blood lipids (TC,TG,LDL,HDL),fasting insulin,TCM Syndrome points;②security indicators:renal function(Cr),liver function(ALT);only in pre-treatment testing to screening of patients with serious liver and kidney dysfunction.3.6 Evaluation:The analysis of determination of value before and after treatment(fasting and two hours of postprandial venous blood glucose, glycosylated hemoglobin,lipids,fasting insulin) and their inter-group changes in the margin.Under the integral method to determine efficacy of traditional Chinese medicine.4.Results4.1 Comparison of clinical general information:the study and control groups in age,sex,duration of inter-group differences were not statistically significant,comparable.4.2 The study and control groups before treatment in fasting and postprandial 2 hours of intravenous glucose,glycosylated hemoglobin, lipids,fasting insulin group were not statistically significant.4.3 The impact on blood sugar:Patients in this study after 12 weeks in accordance with the recipe for diet therapy,the study group and control group of glycosylated hemoglobin and postprandial 2 hours blood glucose are decreased.Compared with pre-treatment,the differences were significant(P＜0.05).The fasting blood glucose of study group and control group,compared with before treatment,there was no significant difference(P＞0.05).But the fasting blood glucose of study group has significant downward trend than the control group.However,there was no significant difference(P＞0.05)between the determination of the value two groups after treatment and the pre-treatment.It means that diet therapy has effects on reducing glycosylated hemoglobin and postprandial two hours blood glucose.The recipes added theory of traditional Chinese medicine has slight the advantage in improving the fasting blood glucose than the basic diet.4.4 The impact on fasting insulin:Patients in this study after 12 weeks in accordance with the recipe for diet therapy,the study group and control group,the fasting insulin compared with before treatment there was no significant difference(P＞0.05);The determination of the value difference of after treatment and pre-treatment of the two groups was not significant(P＞0.05).4.5 The impact on blood lipid:Patients in this study after 12 weeks in accordance with the recipe for diet therapy,the study group and control group,the TC and LDL compared with before treatment there was no significant difference(P＞0.05);determination of TG of Study group and control group declined compared with pre-treatment,but there was no significant difference(P＞0.05);determination of HDLof Study group and control group increased compared with pre-treatment,but there was no significant difference(P＞0.05);the determination of the value difference of after treatment and pre-treatment of the two groups was not significant(P＞0.05).It indicates that diet improve TG and HDL,but the sample size small,so there was no statistical difference.4.6 The impact on clinical symptoms:Patientsof study group after 12 weeks in accordance with the recipe for diet therapy,compared with the control group,were better improved in the syndrome of traditional Chinese medicine.Cold group of study group 54.8%efficient,in the control group 38.7%efficient,there was no significant difference(P＞0.05).Heat Group of Study Group has 59.4 percent efficiency,and the efficiency of the control group was 34.3%.The difference was statistically significant(P＜0.05).The total study group(cold+heat group) 57.1%efficient,the control group(cold+heat group) 36.4%efficient,the difference was statistically significant(P＜0.05).It hints that the recipes added theory of traditional Chinese medicine has the advantage in improving the clinical syndrome,especially for heat group.5.ConclusionThe diet control programs for type 2 diabetes,based on the theory of Chinese medicine,just as the basic diet control programs,can reduce blood glucose,has better effect on glycosylated hemoglobin and postprandialtwo hours blood glucose than fasting blood glucose,but it has better effect on fasting blood glucose than the basic diet.In the regulation of blood lipids,the treatment group same as the basic diet, showed an improving trend on the TG and HDL.In improving clinical symptoms,it has obvious advantage.It means the diet for type 2 diabetes based on the theory is more in line with the Chinese people's physical and eating habits. |
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