Nghiên cứu áp lực bàn chân, mối liên quan với dẫn truyền thần kinh, chỉ số cổ chân – cánh tay ở bệnh nhân đái tháo đường týp 2 tt tiếng anh

1 INTRODUCTION Diabetes is one of the three most developping diseases in the world According to the WHO announcement in 2014, there were 422 millions diabetes patients, taking account to 8,5% population The prevalence has increased through three decades, especially in the poor and developing countries The increase of diabetes prevanlence also accords to its complication It is the cause of cardiovascular accidents, blindness, renal failure, amputation and others which reduce life quality In 2015, the association of foot wound, the foot complication of diabetes has enormously affected the national economics, the prevalence in the developed country is about 2% to 4%, and could be higher in the developing country The worldwide rate of diabetic foot ulcer is 6,3%, male is higher than female, type higher than type The North America had highest prevalence 13%, then Australia 3,0%; Asia 5,5%, Africa 7,1%, European 5,1% In India, about 5% diabetic patients have the foot wound The porpotion of amputation in diabetic foot complication is 40% In the developping country like England, 50% diabetics patients were admitted because of foot wound Another research in 6000 patients showed that foot ulcer was 20% and amputation was 2,5% In many researches of the Vietnam National Hospital of Endocrinology showed that the prevalence of late stage diabetic patients with the foot and amputation complications was high (about 40%) The foot complication is the consequence of causes such as: nerves, vessels, injuries, trauma and infection The diabetic foot complication mechanism is the close combination of three factors: vascular, nerve injuries and infection, sometimes these factors could appear independently Some studies showed that the pressure points of foot have a close relationship with the foot ulcer Therefore, the plantar pressure is the predictive factor in diabetic foot complication patients However, there is no research which evaluates the change of plantar pressure in term of recognization, prevention and reduce the foot injuries of diabetic patients This thesis “Assessment of the plantar pressure in the relation with nerve conduction, and ankle-brachial index (ABI) in type diabetes patients” aims to: Assessment the plantar pressure and some nerve conduction index, ankle-brachial index in type diabetes patients Evaluation the relation between the plantar pressure, nerve conduction index, ankle-brachial index and characteristics in type diabetes patients The new contribution of the thesis: - This thesis showed that the prevalence of increase plantar pressure measured in the base of the first toe in the diabetic patients was 79,4% and base of the third toe was 44,4% - The plantar pressure increased with the level of nerve injury It was statistically significant between the plantar pressure and the potential nerve conduction - The plantar pressure in diabetic patients increases with the level of peripheral artery (assessed by the ABI), significantly positive correlation with the plantar pressure of the second, third and fifth toes (assessed by the ABI) Structure of the thesis This thesis includes 122 pages: Introduction pages, General description 34 pages, Subjects and Methodology 21 pages, Result 30 pages, Discussion 33 pages, Conclusion page, Proposal page, 52 tables, graphs, map, 12 pictures, 122 references (33 Vietnamese, 90 English) Chapter 1: GENERAL DESCRIPTION 1.1 DIABETES 1.1.1 Definition Diabetes is the metabolic disorder, characterized by the hyperglycemia caused by the shortage of insulin secretion, the action of insulin or both The long term hyperglycemia leads to others metabolic disorders such as metabolism of carbohydrate, protein, and lipid, which lead to others organs injuries, especially cardiovascular, renal, ophthalmologic, neurologic diseases 1.1.2 Risk factors The risks factors of type diabetes are classified in four categories: genetics, human race, habits, lifestyle, and intermediate risks Genetic factors Human race (age, gender, race) Lifestyle and habits relating risk factors • Obesity (distribution and related risk factors) • Inactivity • Diet • Others - Stress - Lifestyle: urbanization, modernization - The factors which relate to the gestation such as: status of delivery, gestation diabetes, diabetes, the next generation of the diabetic patients, the uterus environment 1.1.3 The diagnosis criteria of diabetes - Fasting plasma glucose (FPG) ≥ 7mmol/l (126mg/dl) Fasting at least hours before blood test Or - Plasma glucose after hours ≥ 11,1 mmol/l (≥ 200mg/dl) with the oral glucose tolerance test (WHO), 75 g glucose (anhydrous glucose) diluted in 200 ml water Or - HbA1c ≥ 6,5 % (48mmol/mol), blood test approved by the NGSP and standardized in DCCT assay Or - Typical signs and symptoms of hyperglycemia (polyuria, polydipsia, polyphagia, lose weight), beside HbA1c, there are others tests have to be re-done to confirm the diagnosis The second time doing the test should be further from the first time 1-7 days 1.2 The plantar pressure 1.2.1 Definition - The maximum pressure which directly contacts to the ground, is weighted to the foot in standing position on the flat surface - Peak pressure is the pressure to a square unit It is counted by the division of total pressure to the total affected square 1.2.2 The factors of plantar pressure increasing * Neurologic factors: - Motor nerve: It seems to be the most important factor which increases the plantar pressure - Autonomic nerve: the disorder closely relates to the degeneration of sensory nerve * Peripheral vascularization: the peripheral vascular disease is also important factor of increase plantar pressure * Immobility of joint * Other factors: Age, gender, weight, amputation, race 1.2.3 The consequence of plantar pressure increasing: - Foot corn - Foot deformity - Foot ulceration - Amputation 1.2.4 The solutions for reducing the plantar pressure It is the first priority in the treatment - Rest in bed - Wheelchair - Crutch - External fixation - Cushion - Special sandal 1.3 The neuropathies in diabetes The neuropathy in diabetes: symptomatic reduction function of nerve fiber (pain, needling, numbness…) or asymptomatic (after ruling out other causes) 1.3.1 The classification of diabetic neuropathy: - Peripheral neuropathy is the most important complication The prevalence increases with the time of diagnosis With the type diabetes, the neuropathy usually appears at the time of diagnosis, even before years - The diabetic neuropathy are sensory, motor, and autonomic - Phân loại dựa theo kiểu hình tổn thương hệ thần kinh ngoại biên sử dụng rộng rãi nhất, theo cách phân loại này, phân chia bệnh thần kinh ngoại biên thành hai nhóm lớn nhóm có triệu chứng phân bố đối xứng nhóm có triệu chứng phân bố không đối xứng 1.3.2 The evaluating method of neuropathy lesion - Two basic techniques of electromyography diagnosis: surveillance of the nerve conduction and needle electrode - The surveillance of EMG helps to evaluate the ability of electrical conduction of peripheral nerve The concerned index are the peripheral motor potential time (or sensory), the conduction speed, the average potential time, and the frequency of F and H waves 1.4 The vascular lesion in diabetic foot patients - The obstruction of the peripheral vascular is the second important cause of foot ulcer in diabetes It is affected by the: adhesive level of platelets, number of monocytes, lipidemia, smooth muscle, calcium concentration … This condition is much more severe in the high risk subjects such as: hypertension, smoking, obesity… The mechanisms are: - Atherosclerosis - Vascular obstruction causing by the platelets - Less elasticity, less oxygenation, less nutrition… 1.4.2 The evaluating the vascular lesion method of lower limbs - There are varieties of method which evaluate the lower limbs vasculopathy In this study, the ABI was used, measured by the pulse Doppler handling machine + Ankle-brachial index (ABI) + Vascular Doppler ultrasound … 1.5 The studies of plantar pressure, nerve conduction index and ABI * The studies of plantar pressure - Yang Chang et al studied the change of plantar pressure in Chinese diabetic patients The cross-sectioned study in 649 diabetic patients and 808 normal Chinese people who had got diabetes, all was measured by the EMED AT system It showed that the total plantar pressure and its distribution were different It could be a factor which contributes the foot ulcer - In 2014 Fernando performed a cross-section study which compared the pressure in the diabetic patients with neuropathic and ulcerative foot complication It showed that the plantar pressure in the diabetic patients with neuropathic complication and history of ulceration was higher than individuals without history of ulceration - In 2014 Tuna Hakan, Birane Murat et al studied in 84 type diabetic patients, showed the decrease of contact square and the increase of foot peak pressure in the more than 10 years diabetic patients - In 2012, Anita Raspovic 1, Karl B Landorf showed the key role of plantar pressure reduction in the prevention and treatment of foot ulceration in diabetic patients - A study of Madhale Milka D, Godhi Ashoc S in 2017 pointing on the plantar pressure evaluation measured by the machine Novel, performed in 110 Indian patients, who was separated into groups (normal: 30 subjects, type diabetic patients: 30 patients, type diabetic patients with the peripheral complication: 19 patients; diabetic patients with foot ulceration: 31 patients) showed the significance of plantar pressure observation in prevention and reduction the foot ulceration in type diabetic patients * The researches of ABI - In 2011, Nghi Tran Bao and Dung Ho Thuong researched the diagnosis value of ABI index and the risk factor in the peripheral artery disease of the lower limb in the diabetic patients, the crosssection study showed: the sensitivity and specificity of ABI in the peripheral artery disease diagnosis was 90,9 % and 91,0%, respectively - In 2012 Bao Le Hoang and Dao Nguyen Thi Bich performed in 153 type diabetic patients It showed that the proportion of ABI < 0,91: 23,5%; ABI 0,91 – 1,3: 73,9%; and ABI > 1,3: 2,6% - In 2018 Ngan Nguyen Thi and Nhan Nguyen Thi performed a research of the risk factors, ABI, Doppler ultrasound of lower limb artery in the diabetic patients, this cross section study in the Internal Medicine Department of Hue Central Hospital It showed that 26,3% diabetic patients with ABI < 0,9; 69,5% diabetic patients with ABI ranged from 0,91 to 1,3 and 4,2% patients with ABI > 1,3 * The research of peripheral nervepathy - In 2012 Kha Ton That and Hung Nguyen Trong studied about peripheral neuropathy in 84 type diabetic patients It showed the 100% patients with abnormal EMG - In 2015 Banach M et al studied the benefits of nerve conduction mesurement in diabetic patients with polyneuropathic It showed that 57% patients with the abnormalities in EMG diagnosis and decrease amplification of sensory and mortor conduction of lower limb - In 2015 Prasad N et al studied in 40 type diabetic patients, average age 2,28±1,51 years old It showed the decrease of nerve conduction between the diabetic patients 54,32±6,03m/s in comparison with non diabetic patients 59,52±6,51m/s - In 2016 Truong Pham Cong, Vinh Hoang Trung performed a prospective cross section study in 53 type diabetic patients in Ho Chi Minh city It showed that the proportion of objective sensory abnormality increases with the prolong of diagnosis and untrollable HbA1c level The sensory and motor conduction amplification measured in the median nerve was positive correlation; the potential motor and sensory conduction time measured in the median nerve was negative correlation with HbA1c The conduction amplification and velocity measured in the tibia nerve was negative correlation with HbA1c Chapter 2: SUBJECTS AND METHODOLOGY 2.1 Subjects The patient group (the case): 126 patient with type diabetes, examined and treated in the National Hospital of Endocrinology All of them was satisfied the inclusion and exclusion criteria The controls: 40 healthy individuals who satisfied the inclusion and exclusion criteria 2.1.1 Inclusion criteria * The criteria of the case: - Type diabetic patients ≥ 30 years old with male and female - Informed consent and accepted to joint the study - Enough the necessary data for the study * The control criteria: - Healthy individuals who had the casual examination ≥ 18 years old with male and female - Without obesity or overweight - Without chronic diseases: shock, stroke, paralysis - Non-pregnancy woman - Informed consent and accept to joint the study - Enough the necessary data for the study 2.1.2 The exclusion criteria * For the case: - Type diabetic patients with the foot complication (ulceration more than level and amputation) - Acute disease: shock, stroke - Pregnancy woman - Unconsented patients - Unable to measure the plantar pressure * For the controls: - Acute and chronic diseases - Overweight, obesity, pregnancy woman - Unconsented individuals - Unable to question all the necessary information 2.2 The methodology Design: Descriptive cross sectional study Time: from 2015 to 2018 Place: - The case: patients with type diabetes in National Hospital of Endocrinology - The controls: healthy individuals in Institute of Diabetes and Metabolism disorder Diagnosis criteria of Diabetes: Vietnam National Endocrinology – Diabetes Association Plantar pressure measurement: In this thesis, the plantar pressure of the control (TB ± 1SD) would be used as the criteria for comparing with the case + The plantar pressure of case > TB ± 1SD of the control is considered as increase + The plantar pressure of case < TB ± 1SD of the control is considered as decrease The data analysis: using the softwear SPSS 22.0 10 + Logarithms technique to show the standard distribution before analysis + The avarage value define, standard deviation, median, avarage multiplies with the 95%CI + Comparison the averages by the T test Chi-Square and Fissher Exact was employed to compare the difference % + Nonparametric statistics to compare medians + Correlation coefficient + Regression line defined by the linear regression Chapter 3: RESULTS 3.1 The characteristics of the subjects Table 3.1 The distribution of gender and age of subjects Age groups 20 – 29 years old 30 - 39 years old 40 - 49 years old 50 – 59 years old ≥ 60 years old Average The controls (n = 40) n % The cases (n = 126) n % 15.0 0.0 13 32.5 12 9.5 22.5 21 16.7 12 30.0 62 49.2 0.0 41.47 ± 10.10 31 24.6 54.19 ± 9.60 p < 0.05 < 0.05 The cases: The most common was from 50-59 years old, there was no one under 30 years old - The controls: The most common was from 30 to 39 years old, there was no one older than 60 years old - Graph 3.1 The distribution of the subjects regarding to gender 12 The triglyceride, LDL-C concentration in the case group was higher than control groups, statistical significance 3.2 The change of plantar pressure and nerve conduction index, ABI in type diabetic patients 3.2.1 The change of plantar pressure Table 3.5 Characteristics of peak pressure of right foot The peak pressure of right foot (kpa) Total (kpa) Heel (kpa) Middle (kpa) MH1 (kpa) MH2 (kpa) MH3 (kpa) MH4 (kpa) MH5 (kpa) First toe (kpa) Second toe (kpa) 3rd 4th 5th toes (kpa) - Control (n=40) Case (n=126) p 334.06 ± 104.83 185.62 ± 40.04 97.29 ± 26.07 151.46 ± 75.52 220.40 ± 52.20 222.60 ± 47.15 158.21 ± 32.91 133.63 ± 73.13 270.33 ± 133.57 121.21 ± 47.78 85.19 ± 49.09 386.39 ± 123.54 198.17 ± 50.62 107.84 ± 35.04 166.08 ± 69.30 248.09 ± 68.55 246.37 ± 64.69 187.78 ± 56.18 160.45 ± 98.94 287.53 ± 148.65 128.82 ± 55.87 94.97 ± 50.37 0.05 >0.05 >0.05 0.05 >0.05 The peak pressure of the whole foot and peak pressure of MH2, MH3, MH4 regions in the case group was higher than control group, statistical significance The peak pressure of other regions in the foot was not significantly different Table 3.6 The distribution of the foot peak pressure The peak pressure of the right foot Total (kpa) Heel (kpa) Middle (kpa) MH1 (kpa) MH2 (kpa) MH3 (kpa) MH4 (kpa) MH5 (kpa) First toe (kpa) Decrease n % 1.6 18 14.3 11 8.7 0.8 15 11.9 17 13.5 12 9.5 4.8 16 12.7 Case ( n = 126) Normal n % 97 77.0 70 55.6 83 65.9 25 19.8 70 55.6 65 51.6 57 45.2 94 74.6 87 69.0 Increase n % 27 21.4 38 30.2 32 25.4 100 79.4 41 32.5 44 34.9 57 45.2 26 20.6 23 18.3 13 Second toe (kpa) 3rd 4th 5th toes (kap) 17 13.5 7.1 90 95 71.4 75.4 19 22 15.1 17.5 In the increase foot peak pressure, the most common location was the first toe then the second toe Table 3.7 The characteristics of peak left plantar pressure Peak left plantar pressure Total (kpa) Heel (kpa) Middle (kpa) MH1 (kpa) MH2 (kpa) MH3 (kpa) MH4 (kpa) MH5 (kpa) First toe (kpa) Second toe (kpa) 3th 4th 5th toes (kap) - Control (n=40) 316.43 ± 107.22 184.86 ± 41.13 114.48 ± 35.65 151.12 ± 49.56 221.43 ± 52.21 216.77 ± 36.09 166.43 ± 37.28 140.75 ± 62.48 237.29 ± 139.22 143.36 ± 119.73 96.73 ± 50.14 Case (n=126) 392.85 ± 129.21 209.77 ± 60.72 103.14 ± 27.50 182.21 ± 86.64 262.50 ± 90.69 251.42 ± 63.96 179.93 ± 50.57 146.80 ± 87.17 284.64 ± 133.54 122.74 ± 56.32 89.01 ± 51.40 p 0.05 > 0.05 > 0.05 There was no statistically significant difference of conduction between the right and left common peroneal nerves Table 3.10 The conduction of tibia nerve Index Right tibia nerve Left tibia nerve p Potential time (ms) 12,56 ± 1,61 12,41 ± 1,69 > (min – max) (9,3 – 18,8) (8,7 – 19,3) 0,05 Amplitude (mV) 9,67 ± 6,80 8,84 ± 5,71 > (min – max) (0,1 – 74) (0,3 – 60,2) 0,05 Velocity (m/s) 43,26 ± 4,69 42,85 ± 4,06 > (min – max) (26 – 54) (29 – 53) 0,05 There was no difference of conduction between the two groups p>0.05 Table 3.11 The conduction of saphenous nerve Index Potential time (ms) (min – max) Amplitude (µV) (min – max) Velocity (m/s) (min – max) The right saphenous nerve 2.43 ± 0.49 (1.5 – 4.1) 11.59 ± 5.44 (0.1 – 24.6) 53.49 ± 6.70 (34 – 85) The left saphenous nerve 2.46 ± 0.48 (1.5 – 3.7) 13.76 ± 7.72 (4 – 39.8) 53.35 ± 5.30 (50 – 180) p > 0.05 > 0.05 > 0.05 15 There was the difference between the left and right conduction (right > left) However, this difference was not statistically significant Table 3.12 The superficial fibular nerve Index Potential time (ms) (min – max) Amplitude (µV) (min – max) Velocity (m/s) (min – max) The right superficial fibular nerve The left superficial fibular nerve p 2.15 ± 0.40 (1.4 – 4.1) 2.12 ± 0.38 (1.3 – 3.6) > 0.05 9.82 ± 4.68 (4 – 25) 55.78 ± 5.06 (42 – 69) 10.76 ± 5.50 (4 – 35) 55.10 ± 5.57 (31 – 67) > 0.05 > 0.05 The conduction of the right was higher than the left However, this difference was not statistically different p>0.05 3.2.3 The change of ankle-brachial index (ABI) Table 3.13 The distribution of ABI (n=126) Value range ≤ 0.9 0.91 – 1.29 ≥ 1.3 Right n 107 19 Ankle-brachial index Left Total % n % n % 0.0 0.0 0.0 84.9 107 84.9 100 79.4 15.1 19 15.1 26 20.6 There was no subject with ABI under 0.9; there was 20.6% subjects with ABI ≥ 1.3 3.3 The relationship between the plantar pressure and nerve conduction, ABI and the characteristics of type diabetic patients 3.3.1 The relationship between the plantar pressure index and characteristics of subjects Table 3.14 The distribution of plantar pressure in the respect of hypertension (n=126) The peak pressure (kpa) Right foot Non HP1 Hypertension2 (n=84) (n=42) p12 Left foot Non HP3 Hypertension4 (n=84) (n=42) Total 384.4±119.6 395.9±143.2 >0.05 390.7±118 402.7±175.6 Heel 196.6±50.6 205.6±51.3 >0.05 206.4±51.0 225.7±93.8 106.0±36 116.4±29.3 >0.05 101.1±25.2 112.7±35.6 166.0±73.8 166.3±43.7 >0.05 183.9±85.3 174.4±94.5 Middle MH1 p34 >0.0 >0.0 >0.0 >0.0 16 MH2 247.3±64.9 251.9±85.4 >0.05 257.2±68.4 MH3 246.4±63.7 246.4±70.9 >0.05 248.0±58.9 267.3±83.7 MH4 188.2±58.1 185.9±47.3 >0.05 179.7±52.1 180.8±43.7 MH5 162.0±104.7 152.9±66.9 >0.05 142.7±82.5 165.9±106.5 First toe 285.7±136.6 296.4±199.8 >0.05 291.9±127.1 250.5±159.2 2nd toe 126.9±56.8 137.8±51.6 >0.05 120.3±56.3 134.3±56.4 93.5±51.0 102.0±47.7 >0.05 104.9±56.6 rd th th toes 85.6±49.9 287.5±158.3 There was no statistically significant difference of the foot peak pressure between hypertension and non-hypertension patients, p>0,05 Table 3.15 The distribution of peak plantar pressure according to the dyslipidemia (n=126) Right foot Dyslipidem Non1 ia2 (n=24) (n=102) 399.5±86 382.9±131 Total 183.0±47 Heel 202.1±51.1 113.2±45 Middle 106.1±31.9 153.4±47 MH1 168.8±73.6 256.4±82 MH2 245.9±65.4 248.4±74 MH3 246.2±62.8 172.2±47 MH4 192.1±57.5 181.2±122 MH5 155.6±93.1 290.6±133 285.6±152 First toe Peak pressure (kpa) p12 Left foot Dyslipidem p34 Non ia2 (n=24) (n=102) >0.05 365.4±70 398.3±139 >0.05 0 97.7±35.1 103.9±25.0 05 05 >0 165.2±59 >0 187.1±91.7 05 05 >0 268.0±74 >0 261.2±94.8 05 05 >0 261.2±61 >0 249.1±65 05 05 >0 165.6±49 >0 183.1±50.6 05 05 >0 141.2±92 >0 144.6±78.8 05 05 >0 274.0±104 288.8±139 >0 05 05 >0.0 >0.0 >0.0 >0.0 >0.0 >0.0 >0.0 17 141.6±64 125.5±53.9 103.5±59 93.3±48.3 2nd toe 3rd 4th 5th toes >0 05 >0 05 124.4±54 122.0±57.3 98.9±63.3 86.3±48.4 >0 05 >0 05 The foot peak pressure measured in almost point in the dyslipidemia group was no different with the non-dyslipidemia Except in the heel, the pressure of the dyslipidemia one was statistically significant difference p0.05 r, p -0.07; >0.05 -0.042; Heel >0.05 Middle 0.081; >0.05 MH1 0.067; >0.05 Y=28.38X+212 0.21; 0.05 Y=36.26X+206 0.23; 0.05 0.06; >0.05 0.16; >0.05 Y=65.71X+64.4 0.28; 0.05 -0.07; First toe >0.05 Second toe 0.09; >0.05 0.09; >0.05 3th 4th 5th -0.05; >0.05 -0.01; toes >0.05 Total The peak pressure of MH2 right foot region, MH3 left foot region and MH5 left foot region had the positive correlation with the ABI in type diabetic patients with p< 0.05 20 Chapter DISCUSSIONS 4.1 The main characteristics of the subjects The study performed in 126 subjects, which was divided into two groups: The cases group included 126 type diabetic patients and The control group included 40 individuals without diabetes In this thesis, there was a difference of the age group; BMI; waist/hip, the biochemistry tests between the case and control group, because we collected the healthy individuals for the control group This aimed to drawn the average plantar pressure of these to compare with the case group * Gender: in the case group, 68.3% male and 31.7% female In the control, 65% male and 35% female It was the same as the study of Chao xu et al in 2017, the normal plantar pressure measured by the Footscan machine in 32 individuals (46.9% female and 53.1% male) * Age: There was many studies which confirmed the difference between age , sex and plantar pressure * BMI: The average BMI in this thesis was lower than Fernando et al study: the control 21.1 ± 2.16 and the case 22.96 ± 3.07 * The patient history: 50% patients were diagnosed before the symptom 10 years * The characteristic of biochemical tests in serum: because of the case group was in the treatment period, therefore the results of plasma glucose, HbA1c and dyslipidemia test was significantly higher than the control Comparing to the study of Dien Le Thanh about the clinical characteristics and the EMG abnormality in the type diabetic patients with 194 patients showed that: the average plasma glucose was 8.12 ± 2.26 mmol/l and HbA1c 7.56 ± 1.22 % lower than our study (10.8 ± 4.65 mmol/l; HbA1c: 9.49 ± 4.34 %) Hence, this study was similar with some in the world, the bio tests was fited into the developpment of disease 21 4.2 The change of plantar pressure and nerve conduction index, ankle-brachial index 4.2.1 The change of plantar pressure In this study, the machine Emed A 50 to measure the plantar pressure showed that the total plantar pressure of control group was 334.06 ± 104, 06 kpa, significantly lower with the case group 386.39 ± 123.64 kpa, p