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INTRODUCTION Metabolic syndrome refers to a group of disorders related to the process of metabolizing substances including lipid metabolism disorder, abdominal fat, high blood pressure and blood glucose (blood sugar) disorder In patients with diabetes, blood glucose levels tend to be not properly regulated; this would allow long-term carbohydrate disorders to result in lipid metabolism disorders, high blood pressure, body fat accumulation and finally, metabolic syndrome The appearance of metabolic syndrome among type diabetes patients worsens the severity of the disease and further causes dangerous complications, especially to blood vessels and nerves In Vietnam, white rice the chief source of energy in people’s meals Carbohydrate (a part of Carbohydrate) constitutes quite a large percentage of the total energy (70%) in the meals However, after rice grain is milled, it loses 85% of its fat content, 15% of its protein content, 75% of its phosphorus content, 90% of its calcium content, 75% of its vitamin Bs, iron, magnesium and especially the fiber content that exist chiefly in its bran and germ layers Germinated Brown Rice (GBR) is made from rice grain that has only the husk milled away, thus keeping the bran and germ layers intact After removing the husk, the rice is then soaked in warm water until the sprouts grow slightly Subsequently, the rice is dried The germination process of brown rice increases the amount of biological chemicals located in rice bran that could help control blood glucose and blood lipid levels In order to collect more scientific data on the current state of & risk factors contributing to the prevalence of metabolic syndrome among type diabetes, along with the effects of using Germinated Brown Rice (GBR) in helping control the components of metabolic syndrome, we have conducted the research with the two following objectives: Determine the current state of & risk factors contributing to the prevalence of metabolic syndrome among type diabetes outpatients at Vu Thu General Hospital, Thai Binh Province were facing in 2016 Evaluate the effects of Germinated Brown Rice (GBR) in helping control the components of metabolic syndrome among type diabetic outpatients that have metabolic syndrome New contributions of the research This research has provided additional important scientific data on the current state of & risk factors contributing to the prevalence of metabolic syndrome among type diabetes patients This is the first time ever the data on the current situation of metabolic syndrome along with its associated risk factors in type diabetes patients are publicized and, domestically, at the present, there are only very few studies on these problems GBR - Germinated Brown Rice is the result of a scientific application in which husked brown rice is germinated, thus increasing the amount of beneficial nutrients that could help control the components of metabolic syndrome in type diabetes patients located in its bran and germ layers This is the product that can completely replace white rice in daily consumption Structure of the thesis The thesis consists of 134 pages, 36 tables, 10 pictures and 135 references including documents from foreign sources The introduction is 03 pages, overview 32 pages, subjects and methods of research 21 pages, research results 31 pages, discussion 44 pages, conclusion 02 pages and recommendation 01 page Chapter 1: OVERVIEW OF THE THESIS 1.1 Diagnostic criteria for metabolic syndrome At the present, there are many criteria used to diagnose metabolic syndrome Depending on the opinion on pathogenesis and prevention mechanism, each organization provides different diagnostic criteria Firstly, the experts of WHO, based on Reaven’s concept, produced a new definition on metabolic syndrome with specific diagnostic criteria Afterwards, European Group for the Research of Insulin Resistance (EGIR), National Cholesterol Education Program - Adult Treatment Panel-III (NCEP-ATPIII) provided a definition for metabolic syndrome in 2001 and updated it in 2005, International Diabetes Federation (IDF) also produced a definition for themselves These sets of criteria all agree that the main components of metabolic syndrome are glucose malabsorption, obesity, high blood pressure and lipid metabolism disorders; however, each criteria set is different from the other regarding the dominant risk factors and the threshold used to determine the components The criteria of WHO and EGIR both state that glucose malabsorption and insulin resistance as the major risk factors Conversely, the criteria set of NCEP does not include insulin resistance as a component in their diagnosis In 2009, the common criteria formed from the criteria sets of all the aforementioned organizations for diagnosing metabolic syndrome contained 03 among 05 components above including: wider waist circumference, high triglycerides, low HDL-C, high blood pressure and high blood glucose Abdominal fat was not an essential criterion in diagnosing metabolic syndrome but it was one among the five main criteria and was effective in initial screening 1.2 The current state of metabolic syndrome among type diabetes patients Overall, the studies on metabolic syndrome among type diabetes patients all over the World and Vietnam are still quite limited and they all show that the prevalence of metabolic syndrome in type diabetes patients is high The research of S H Song shows that the prevalence of metabolic syndrome in type diabetes patients undergoing treatment at the hospital at the time, for both male and female, measured according to the IDF criteria, was 91.7% and 94.8%, and according to the criteria of NCEP-ATPIII was 87.6 and 94.2%, respectively A research in Pakistan in 2012 shows that the prevalence of metabolic syndrome in type diabetes patients according to WHO criteria was 81.4% The research conducted by Le Thanh Duc at Vinh Long General Hospital illustrates that the prevalence of metabolic syndrome in accordance with IDF criteria was 59% Another research conducted at Ho Chi Minh city in 2004 states that the prevalence of metabolic syndrome according to NCEP-ATPIII’s criteria was 77.6%, according to NCEP-ATPIII’s criteria for Asian people was 86.0%, according to WHO 1999’s criteria was 91.4% and according to WHO 1999’s criteria for Asian people was 92.4% 1.3 The risk factors contributing to the prevalence of metabolic syndrome Physical activities: Physical activities are a very important factor in the process of energy expenditure; physical activities enable the body to balance between then energy intake and the energy consumed On the other hand, physical activities also promote for beneficial energy conversion in the body, thus reducing fat, promoting insulin sensitivity and reducing blood insulin Sex: Many researches have shown that the prevalence of metabolic syndrome among female type diabetes patients is higher than that of the male counterpart This may be because it is more likely for women to have abdominal fat and female hormones increase the likelihood of having the components of metabolic syndrome Smoking and drinking: Many studies have shown that smoking and drinking alcohol or beer could lead to high blood pressure, wider waist circumference and high triglycerides, as well as low HDL-C and lowered insulin sensitivity or insulin resistance Frequency of consumption of a few types of food: Diet is one of the essential factors that directly affects obesity, diabetes and metabolic syndrome A surplus supply of energy from meals that contain a large quantity of fat, sugar, of unreasonable portions, an imbalance between nutrients such as lipid, carbohydrate, protein, amino acids… shall result in carbohydrate and lipid disorder 1.4 The nutrition content in Germinated Brown Rice (GBR) GBR is produced by soaking husked brown rice in water and let germinate The germination process would soften the rice when cooked as well as render it tastier than husked brown rice; in addition, this also enriches the amount of active substances found in husked brown rice such as Gamma-aminobutyric acid, acylated steryl glucosides, inositol hexaphosphate, ferulic acid, inositol, γoryzanol, tocopherols, tocotrienols, vitamins and minerals - The effects of GBR on controlling post-meal blood glucose and blood insulin levels in healthy people were measured under two diets, one had the ratio of white rice/GBR being 2/1 and the other 1/2; the blood sugar levels after 120 mins of the GBR-heavy diet was 54.4±5.1, statistically lower than that of the white rice-heavy diet, which was 74.6±6.2 mg/dl, the blood sugar levels is in reverse proportion with the ration of GBR/white rice - The effects of GBR on controlling blood glucose and blood lipid levels for people with blood sugar disorder when hungry or with diabetes: According to a research on subjects with blood sugar disorder when hungry or diagnosed with diabetes, after weeks of intervention, the group that ate GBR had blood sugar levels lowered compared to before eating GBR (135±7mg/dl and 153±9mg/dl, respectively) The amount of total cholesterol and triglycerides of GBR eating subjects both experienced statistically significant reduction - The effects of GBR on controlling blood glucose levels and weight for pre-diabetes women: Bui Thi Nhung carried out a research on pre-diabetes women aged 45-65 using GBR as the replacement for white rice continuously for 04 months The results show that the post-intervention blood glucose levels, HbA1c, triglycerides, HDL-C, LDL-C all experienced statistically significant changes compared to pre-intervention The figures related to biometry such as weight, BMI, body fat, waist size, hip size, waist/hip ratio all underwent statistically significant changes as well - Tran Ngoc Minh conducted a research on the effects of GBR on controlling post-meal blood glucose levels in type diabetes patients The intervention research results also illustrate that, after 16 weeks, GBR reduced blood glucose levels and helped regulate blood lipid levels compared to preintervention - Effects of GBR on patients with metabolic syndrome A research in which GBR was used as the intervention on metabolic syndrome patients aged 55-70 years old for 03 months continuously shows that the blood glucose levels, insulin, HbA1c, cholesterol, triglycerides, LDL-C all went through statistically significant reduction compared to pre-intervention The prevalence of metabolic syndrome was lowered from 100% down to 70% post-intervention Chapter 2: SUBJECTS AND METHODS OF RESEARCH 2.1 Subjects of the research Pre-intervention phase: Outpatients diagnosed with type diabetes being treated at Vu Thu General Hospital at the time Intervention phase: Pre-intervention patients with metabolic syndrome, aged 45-65 years old at the research location 2.2 Research design Cross-sectional study on the current state of & risk factors contributing to the prevalence of metabolic syndrome among type diabetes patients and a number of related factors Intervention study with a comparison group, compare and assess the before and after intervention results 2.3 Research location: Vu Thu District, Thai Binh Province 2.4 Research time: Over 02 years, from 2016 to 2017 2.5 Sample size and method of selecting sample Sample size: Sample size before intervention: All type diabetes outpatients undergoing treatment at Vu Thu General Hospital, Thai Binh province in 2016 As the result, the research group managed to select 846 subjects after screening all other unqualified patients Intervention subject size: (σ12+σ22/κ) (Z1-α/2 +Z1-β)2 N1 = −−−−−−−−−−−−−−− (μ1- μ2)2 The sample size was n = 43 The research group estimated that 15% of the subjects would quit so the sample size needed to be 50 intervention subjects and 100 comparison subjects In reality, the research group managed to acquire 54 intervention subjects and 108 comparison subjects However, during the intervention process there were 02 subjects of the intervention group and 04 subjects of the comparison group moved to another Province, therefore the data of 52 intervention subjects and 104 comparison subjects was ultimately assessed Subject selection for intervention phase: - Step 1: Make a list of type diabetes patients with metabolic syndrome - Step 2: Select 54 patients, aged 45-65 that not have any diabetes complication yet, and not have their treatment plan changed 06 months prior to the time of intervention Remove patients with acute disease, that are using insulin drugs and supplements that help control blood lipid disorders and blood glucose disorders and are using husked brown rice/germinated brown rice at the time Select subjects for the comparison group: In order to ensure the similarity of the comparison group, for each intervention subject, choose 02 comparison subjects based on criteria: same sex (both are male or female), age gap does not exceed 05 years, HbA1c difference does not exceed 01% Sex, age, HbA1c are the most objective components that are not affected by other unwanted elements during the intervention process 2.6 Contents of the research - Objective no 01 To gather data on the current state of metabolic syndrome prevalence among type diabetes patients: Take biometric measurements, blood pressure, waist measurement, perform blood test to determine whether a subject has metabolic syndrome To determine a number of related social elements: Interview the subjects on their economic and social background, their own characteristics, characteristics of their lifestyle and diets to determine the connections to metabolic syndrome prevalence among type diabetes patients - Objective no 02 Intervene by having the selected subjects eating GBR instead of white rice completely and continuously for 16 weeks in a row Monitor their meals, perform tests and analyze their 24-hour diets for 03 days in a row and compare the results of pre and post intervention 2.7 Techniques used in the research Interview to gather information of the subjects such as age, sex, education, occupation, lifestyle, physical activities, frequency of consuming certain types of food, take their biometric measurements, waist measurement, perform blood test to gather data on glucose, triglycerides, HDLC, total cholesterol, LDL-C, HbA1c and interview them on their 24-hour diets Using Germinated Brown Rice (GBR): GBR used in the test was produced at Viet Nam Biomedical Technology Joint Stock Company at no 117 Thai Binh street, Nam Dinh city, Nam Dinh province using Japanese technology Rice grain was husked and still had its bran and germ layer intact Then the husked rice was soaked in warm water until sprouts grew Subsequently, the rice was dried and bagged Each bag contained 01 kg of rice and was tightly sealed The rice was tested for its nutrition values, heavy metal content and underwent microbiological test at National Institute of Nutrition The subjects were supplied with GBR each week and use it in every meal In the process of cooking the rice was not washed to avoid losing nutrients The rice was cooked in a normal electric cooker, the water content put in depended on the preference of each subject (whether that person preferred eating drier or wet rice) It was required that each subject must eat GBR for the two main meals of the day continuously for the duration of 16 weeks 2.8 Methods of managing, processing and analyzing data The data was entered into EpiData 3.1 software and was analyze on SPSS 16.0 software The statistic tests were used as single variable, multivariate logistic regression; Chi-squared test was used to compare and establish the differences between the groups; independent t test and paired t test were used to compare and establish the differences regarding the average values between the groups The differences were accepted when p2 times/week) Sugary food eating No frequency Yes (>2 times/week) Animal organ eating No frequency Yes (>2 times/week) Fatty-meat eating No frequency Yes (>2 times/week) Egg eating frequency (0-3 meals per week) Yes Additional meal(s) No β OR 20.1 1.04 95%CI p 11.7 - 35.1 1.02 - 1.06

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