tóm tắt luận án hiệu quả kiểm soát glucose máu, cải thiện một số chỉ tiêu hóa sinh của thực phẩm chức năng chiết xuất từ lá vối - ổi - sen (voscap) trên bệnh nhân đtđ type 2 tại hà nội

MINISTRY OF EDUCATION AND TRAINING MINISSTY OF HEALTH THE NATIONAL INSTITUTE OF NUTRITION PHAM THI LAN ANH EFFECTS OF VOSCAP, A FUNCTIONAL FOOD EXTRACTED FROM CLEITOCALYX OPERCULATUS, GUAVA AND LOTUS LEAVES ON CONTROL OF BLOOD GLUCOSEAND SOME BIOCHEMICAL INDICATORSIN PATIENTS WITH DIABETES TYPE 2 IN HANOI SPECIALIZED: NUTRITION CODE: 62.72.03.03 NUTRITION PHD THESIS SUMMARY HA NOI, 2013 WORK TO BE DONE IN NATIONAL INSTITUTE OF NUTRITION ============= Scientific Advisors: 1. Pham Van Hoan Assc Prof., MD., PhD 2. Truong Tuyet Mai MD., PhD Rapportor I: Rapportor II: Rapportor III: The thesis to be defended at the National Institute of Nutrition Training Council The National Institute of Nutrition Ha Noi On … Date … Thesis can be found at: National Library Library of National Institute of Nutrition ABBREVIATIONS LIST ADA: American Diabetes Association ALT: Alanine transaminase AST: Aspartate transaminase BMI: Body Mass Index CTV: Collaborator. ĐTĐ: Diabetes GSV: Supervisor. GI: Glycemic Index Hb: Hemoglobin. HOMA-Insulin :Homeostasis Model of Assessment Insulin Resistance IAUC: Incremental Area Under Curve IC Inhibitory Concentration NGSP: National Glyco-hemoglobin Standardization Progam JNC VII: Joint National Committee 7 THA: Hypertension. TP.HCM: Ho Chi Minh City VOSCAP: Cleitocalyx operculatus, Guava, Lotus capsule WHO: World Health Organization 2 INTRODUCTION Diabetes mellitus type 2 is a non-communicable chronic disease related to nutrition and lifestyle, growing very fast in many countries around the world. Diabetes is a group of metabolic diseases characterized by chronic hyperglycaemia as a result of the lack or reduced activity of insulin or a combination of both. In 2010, it was estimated that the world has about 285 million adults with diabetes aged 20-79, the number continued to grow 154% from 2010 to 2012. In 2013 study of Endocrinology Hospital showed the prevalence of diabetes was 5.7% (7.2% in the South West, lowest was in the Central Highlands 3.8%). The rate of glucose intolerance also increased quickly from 7.7% in 2002 to nearly 12.8% in 2012. Postprandial blood glucose control in patients with diabetes type 2, in addition to weight loss, exercise and diet changes, there is a need to coordinate with diabetes medications, including inhibitors of α-glucosidase. α-glucosidase inhibitors slow the digestion of double track glucose absorption, lead to reduced revenues, thereby slowing the rise of blood glucose after eating. Polyphenols composition of plant have been scientifically demonstrated the ability to inhibit α- glucosidase in the intestinal epithelial cells, helping to limit postprandial hyperglycaemia. Polyphenols also work to improve the activity and insulin secretion, reduce blood fat. VOSCAP 3 combination product is extracted from the leaves of robusta, guava and lotus has only been tested effectively control blood glucose in healthy and diabetic rats. This is the next step, VOSCAP product has been tested on both healthy people and people with diabetes type 2. STUDYOBJECTIVES: 1. To identify the control of postprandial blood glucose of VOSCAP product on healthy and in patients with diabetes type 2. 2. To assess the effects of VOSCAP product on blood glucose control, HbA1c, Insulin Resistance in patients with diabetes type 2 after 12 weeks - trial and the changes in blood glucose 6 weeks after discontinuation of the trial. 3. To assess the changes of some other indicators related biochemical (blood fat and uric acid) and other index (blood pressure, the use of pharmacy diabetes treatment) in patients with diabetes type 2 after 12 weeks - trail of VOSCAP product and the changes in these indicators 6 weeks after discontinuation of the trial. THE NEW CONTRIBUTIONS OF THE THESIS 1. This is a study of Vietnam's first test using VOSCAP product derived from plant extracts of cleitocalyx operculatus, lotus leaves to assess the effect of blood glucose control in both healthy volunteers and patients with diabetes type 2. 2. This is a long-term clinical trials, not just taking VOSCAP product during 12 weeks to evaluate the effectiveness of blood glucose control in healthy volunteers and patients with diabetes type 2, but 4 also continue to monitor for another 6 weeks later the end of the test to assess the ability to maintain the efficiency of the product. 5 CHAPTER 1: OVERVIEW 1.1. The situation of diabetes in the world and Vietnam: 1.1.1. The situation of diabetes in the world: In recent years, disease patterns have changed, the infections tend to a reduction, in contrast to non-communicable diseases such as cardiovascular, psychiatric, cancer especially diabetes and metabolic disorders are increasing. In the late 20th century and early 21st century, the WHO experts had predicted, "The 21st century will be the century of the Endocrine diseases and metabolic disorders, especially diabetes a non-communicable disease would be the fastest growing one”. The number of people with diabetes worldwide increased from 171 million in 2000 to 194 million in 2003, jumped to 246 million in 2006 and forecasted to increase to 380-399 million in 2025. Of which, in the developed countries, the disease rate increased 42% and that in the developing countries increased 170%. Among people with diabetes, the diabetes type 2 mainly accounts for about 85-95%. Diabetes is ranking the 4th in cause of death in the world, causing reduced 5 to 10 years of life expectancy, the leading cause of blindness and end-stage renal failure as well as the leading cause of amputation not due to injury. Every 10 seconds, there is a person dies due to diabetes and its complications, every 30 seconds there is a complication of diabetes foot amputation. The cost of treatment of diabetes worldwide in 2007 was estimated U.S. $ 232 trillion, projected to grow to 302 trillion in 2025. 6 Diabetes increases fastest in countries with economic rapid growth like India, China. The rate of diabetes in the Southeast Asia countries is also relatively high. In the Philippines, in 2008 the diabetes rate was 7.2%, impaired glucose tolerance was 6.5% and fasting blood glucose disorders 2.1%; Diabetes rate in urban areas was 8.3% and rural areas was 5.8%. In 2008, the diabetes rate in Indonesia was 5.7%, the rate of reduced glucose tolerance was 10.2% in the age group above 15 years old. According to Wilds et al., the rate of diabetes of all ages around the world in 2000 increased to 2.8% and in 2030 increase to 4.4% (171 million in 2000 and 366 million in 2030). A research conducted by Shaw JE et al showed the diabetes rates worldwide among adults 20-79 was 6.4% (285 million) and will increase to 7.7% (439 million people) by the year 2030. There are 69% of adults with diabetes in developing countries and 20% in developed countries. A study of David R et al 2011 showed that: In 2011, there were 366 million people with diabetes aged 20-79, this figure expected to rise to 552 million by 2030. 1.1.1. Diabetes situation in Vietnam: In Vietnam, diabetes has tended to increase over time and the level of economic development and urbanization. In 1991, Mai The Trach et al. investigated in 4912 people in Hanoi, by the standards of the World Health organization (WHO 1985), the prevalence of diabetes in subjects over 15 years old was 1.2%, of which 1.44% in the urban and 0.63% in the suburbs; The percentage of blood glucose 7 intolerance was 1.6%. In 1993, Mai The Trach et al. surveyed on 5,416 people over age 15 or older in the HCM city, the results showed diabetes rate was 2.52%. In 2001, the epidemiological investigation on diabetes applied new international standard with the help of leading experts from WHO, conducted in 4 cities: Hanoi, Hai Phong, Da Nang and Ho Chi Minh City. Result of this investigation is really alarm bells about the situation of non-communicable diseases in general and diabetes in particular in Vietnam, the prevalence of diabetes in 4 big cities of Hanoi, Ho Chi Minh City, Hai Phong and Da Nang in subjects aged 30-64 was 4.9%, glucose intolerance rate was 5.9%, the rate of fasting blood glucose disorder was 2.8%, the rate of subjects with risk factors for diabetes was 38.5%; It is so worried that 44% of the people with diabetes has not been diagnosed and given any preventive and treatment guidelines. In 2002, Endocrinology Hospital conducted a national survey of diabetes risk factors on over 9,122 people in 90 wards, ò which 1833 subjects in the Central Highlands, 2722 in the delta region, 2,759 in the cities, 45% of male and 55% of female. The results showed people with diabetes type 2 nearly tripled over the last 10 years; The rate of diabetes type 2 aged 30-69 was about 5.7%; And the rate in the urban and industrial zones was higher, 7,0% - 10%. In 2013, the study of Endocrinology Hospital showed that the prevalence of diabetes was 5.7% (the highest was in the South West at 7.2%, the lowest was 3.8% in the Highland). The rate of glucose 8 intolerance also increased quickly from 7.7% in 2002 to 12.8% in 2012. According to this study, people over age 45 are at risk for diabetes type 24 times higher than those under 45 years of age. People with high blood pressure are at diabetes risk for more than 3 times the other. People with large waist are at diabetes risk for 2.6 times higher. 1.1.3. The consequences of diabetes mellitus type 2: Diabetes is a serious disease threat to life and cause many complications. According to the International Diabetes Association, diabetes is the leading cause of death ranking the 4th or 5th in the developed countries and is being considered epidemic in developing countries. Approximately 50% of diabetic patients with complications such as coronary heart disease, heart attack, stroke, neuropathy, cuts amputation, kidney failure, blindness caused by diabetes. These complications result in disability and reduced life expectancy. Diabetes leads to serious consequences for the health and economy of the entire society. 1.2. Diagnosis of diabetes type 2. According to the ADA, the diagnostic criterias for diabetes since 2010 are: - HbA1c ≥ 6.5%. - Fasting blood glucose level ≥ 7.0 mmol / l (≥ 126mg/dl). - Blood glucose level ≥ 11.1 mmol / l (200mg/dl) at the time of 2 hours after glucose tolerance test orally. 9 [...]... HDL-C (Mean ± SD) Control VOSCAP group group T0 5,3 ± 0,8 5,1 ± 0,9 Cholesterol T6 5,3 ± 1,0 5,3 ± 1,0 (mmol/L) T 12 5 ,2 ± 1,0 4,9 ± 0,9 T 12 - T0 -0 ,15 ± 0,8 -0 ,17 ± 0,6 T0 2, 2 ± 1 ,2 2,0 ± 1,1 Indicator Triglyceride Time point 21 T6 2, 2 ± 1,7 2, 1 ± 1,0 T 12 2,0 ± 1 ,2 2,0 ± 1,0 T 12 - T0 -0 ,18 ± 1,5 -0 ,005 ± 1,05 T0 1,1 ± 0 ,26 1,1 ± 0 ,27 HDL-C T6 1 ± 0 ,24 1 ± 0 ,26 (mmol/L) T 12 1,1 ± 0 ,27 1,1 ± 0, 32 T 12 -. .. T 12 Control group 24 ± 16 28 ± 14 28 ± 14 3,9 ± 10,9 31 ± 24 29 ± 21 33 ± 20 2, 2 ± 14,7 90 ± 23 1 12 ± 24 97 ± 19 6,9± 16,9 367 ± 105 359 ± 1 12 VOSCAP group 25 ± 10 25 ± 8,3 26 ± 7,3 0,7 ± 6,9 26 ± 14 25 ± 12 26 ± 10 -0 ,18 ± 9,5 92 ± 21 98 ± 21 ## 90 ± 17 -2 ,7 ± 10,7# 328 ± 88 329 ± 80 31 0± 97 319± 70 22 Indicator # Time point T 12 -T0 Control group -5 7,5 ± 54,1 VOSCAP group -9 ,3 ± 78,7### p . ± 1 ,27 7,84 ± 0, 92 After 15 minutes 11,30 ± 1,75 10,54 ± 1, 52* After 30 minutes 13,58 ± 2, 04 12, 25 ± 1,95* After 60 minutes 15 ,28 ± 3,36 14,14 ± 2, 15 After 90 minutes 12, 95 ± 3, 12 12, 32 ± 2, 41 After. group Blood Glucose (mmol/L) T0 8,1 ± 0,8 7,9 ± 0,9 T6 8,1 ± 2, 1 7,7 ± 1,7 T 12 7,7 ± 1,5 6,7 ± 1,4*,, # T 12 - T0 -0 ,4 ± 1,4 -1 ,2 ± 1,1* Insulin (pmol/L) T0 72 ± 35 68 ± 32 T 12 76 ± 36 68 ± 31 T 12 - T0. ± 0,68 After 120 minutes 5,11 ± 0,49 5 ,24 ± 0,63 IAUC 0-1 20 minutes 21 4 ,2 105,7 168,4 ± 94 ,2 * * p <0.01, ** p <0.05 compared with control day, t-test. Postprandial blood glucose in the