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RAJIV GANDHI university OF HEALTH SCIENCES, KARNATAKA, BANGALORE ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1. Name of the candidates and address (in block letters) DR.NAVEEN GOLABHAVI M.D. GENERAL MEDICINE MAHADEVAPPA RAMPURE MEDICAL COLLEGE GULBARGA- 585105 KARNATAKA Permanent Address DR.NAVEEN GOLABHAVI “SHIVA NILAY” # 25., LAST CROSS, VIVEKANAND NAGAR, GOKAK-591307 2. Name of Institution H.K.E. SOCIETY’S MAHADEVAPPA RAMPURE MEDICAL COLLEGE, GULBARGA – 585 105. 3. Course of study and subjects M.D. GENERAL MEDICINE 4. Date of admission to the course 30/05/2012 5. Title of topic PREVALENCE OF PERIPHERAL ARTERIAL DISEASE IN TYPE-2 DIABETES MELLITUS AND ITS CORRELATION WITH CORONARY ARTERY DISEASE USING ANKLE-BRACHIAL INDEX 6. Brief Resume of the intended work 6.1 Need for the study Peripheral vascular disease is one of the macrovascular complications of diabetes mellitus and also clinical manifestation of the atherosclerotic process, which is associated with cardiovascular disease (CVD) and increased CVD risk. Diabetes, a major chronic disease, accounts for about 50% of all non-traumatic amputations in India because of Diabetic foot. There is strong correlation between presence of peripheral vascular disease, coronary artery disease and cerebrovascular accidents. Diabetics are five times more likely to develop peripheral arterial disease than non-diabetics as it accelerates atherosclerosis and numerous studies have identified it as a key risk factor for PAD.[1-5] Noninvasive testing reveals that up to 20% of elderly individuals have PAD [6– 9] and because only a small percentage of these individuals are symptomatic, the condition is poorly recognized in primary care practice.[10,11] It is well known that ankle-brachial index (ABI) is simple and useful method to assess the peripheral vascular diseases and it is also widely used in clinical and epidemiological studies [12–14]. Ankle-brachial index (ABI) is the ratio of the resting ankle to brachial systolic blood pressure. A low ABI (<0.90) was considered to be a predictor for risk of cardiovascular diseases [15,16]. The measurement of ABI is also recommended by American Heart Association as a diagnostic criterion for the prevalence of peripheral arterial diseases [16]. However, many population-based association studies between ABI distribution and cardiovascular diseases in type 2 diabetes have been carried out in Western countries, whereas, hardly any such epidemiological data are available in Indian subjects with type 2 diabetes mellitus till date according to the information gathered from pubmed. Therefore, we will conduct a hospital-based study to document the association between distribution of the ankle-brachial index and cardiovascular risk factors in the Gulbarga region subjects diagnosed with type 2 diabetes mellitus in order to provide the baseline data for further prospective study 6.2 Review of Literature 1. Premalatha G. et al [17] - conducted a study called “The Chennai Urban PopulationS tudy” (CUPS) which was population based study on diabetes and its complications in Chennai. All the adults > 20 years of age were included. Totally 1262 subjects were included in study. All the subjects were evaluated by OGTT. Antrhopometric measurements included height, weight and BMI. Doppler study of lower limb was done for 50% of participants i.e 631 subjects. Ankle brachial index (ABI) ratio was calculated in all 631 subjects. A criteria for diagnosis of PVD was an ABI < 0.9. The conclusion of study was the prevalence of PVD is low in Urban South Indian. Population when compared to Western studies. The overall prevalence of PVD in whole population was 32% and it was 11.8% in diabetic population. Other conclusion was ABI is suitable method to assess PVD for epidemiological and clinical studies. 2. Premalatha G et al [18]- Conducted a study with aim to compare specificity and sensitivity of ABI measured by peripheral Doppler with color duplex ultrasound (CDU) for diagnosis of PVD. One hundred type-2 diabetic patients underwent both CDU and ABI measurements. PVD was diagnosed if CDU showed > 50% of arterial stenosis or if ABI < 0.9. They concluded that ABI is good initial screening tool. ABI has a very high specificity and sensitivity is low compared to CDU. 3. Ramachandran A. et al [19]- conducted a study with aim to determine the prevalence of micorvascular and macrovascular complications in Type-2 diabetes in India. Study included 3010 subjects (M: F-1982:1118). The study sample resembled the population sample in anthropometry, age, socioeconomic factors. The prevalence of PVD was 4%. Conclusion of study was. PVD prevalence although less compared to white population, may also pose a major problem due to large number of diabetic subjects with foot infections in India. 4. Nosenko EM et al [20] - Clinical manifestations of arterial insufficiency and characteristics of vascular damage were compared in 68 patients (54 men, 14 women) with atherosclerosis of arteries of lower limbs including 40 patients with typ-2 diabetes. Color duplex scanning was used for assessment of severity of vascular wall involvement. Atherosclerosis of arteries of lower limb in patients with diabetes manifested clinically as neuropathy while intermittent claudication was more characteristic of patients without diabetes. ABI in patients with diabetes was 2-30% and 1.5-2 times higher compared with those without diabetes with similar occlusive and non occlusive changes of arteries of lower limbs respectively. 5. McDermott MM et al [21]- Conducted a study with aim to determine the prevalence of unrecognized lower limb peripheral arterial disease (PAD) among men and women aged >55rs in general internal medicine practice. Totally 239 patients were included in study and they were evaluated for PAD with ABI. PAD is said to be present if ABI is <0.9. They concluded that unrecognized PAD is common among men and among aged 55 years and older in general practice and is associated with impaired lower limb functioning . ABI screening may be necessary to diagnose unrecognized PAD in general practice. 6. Larson MG et al [22]- undertook a study to examine the relation between low ABI and risk of stroke, CHD and death in elderly adults. This study included 674 patients (251 men and 423 women). A low ABI was defined as <0.9 in either leg. The participants were followed for 4 years for occurrence of stroke or TIA, coronary disease and death. They concluded that low ABI is associated with a significantly increased risk of stroke or TIA in the elderly. They note also that ABI measurement is a simple test that can be used to identify stroke-prone elderly people who can then be considered for more aggressive preventive therapies. 7. Yokoyama H et al [23]- conducted a study with aim to examine whether brachial ankle pulse wave velocity a possible early marker of atherosclerotic vascular damage is associated with albuminuria in patients with type-2 diabetes. This study includes 346 type-2 diabetes patients. They concluded that results might indicate possible link between the pathogenesis of atherosclerosis and diabetic nephropathy. 8. Samal KK et al [24]- conducted the study to find out the significance of ABI in diabetes mellitus. 294 patients (175 male, 179 female) were studied. The ABI of less than 1 was taken as index of PVD. Various other complications of diabetes were also studied in cases of PVD. The prevalence of PVD was 12.9%. 9. Banait Vs et al [25]- conducted a study with aims to determine the prevalence of abnormal ABI as indicator of PVD in type-2 diabetes and to correlate the prevalence of cardiovascular risk factors and vascular complication of type-2 diabetes with abnormal ABI. 118 type-2 diabetes patients were included in the study. PVD is said to be present if ABI is <0.9. They concluded hat ABI < 0.9 are characterized by clustering of cardiovascular risk factors like obesity, smoking, hypertension and higher serum cholesterol level and are also associated with increased prevalence of other micro vascular and macrovascular complications. 10. Edward B et al [26]- conducted study with aim to quantify the distribution of peripheral arterial disease in the diabetic and non diabetic population attending for angiography and to compare severity and outcome between both groups of patients. A total of 136 arteriograms were studied. Results showed diabetic patients had greater severity of arterial disease in lower limb. A greater number of amputations occurred in diabetic group; diabetic patients were five times more likely to have an amputation. Mortality was higher in the diabetic group. They concluded that patients with PAD and diabetes have worse arterial disease and poorer outcome than non-diabetic patients. 11. MCAlpine et al [27]- conducted a study with aim to know the annual incidence of diabetic complications in population with diabetes mellitus. In this study 6632 type-2 diabetes patients were included and were evaluated for micro and macrovascular complications of diabetes. The prevalence of PVD was 13.6% in type-2 diabetes. The study concluded that increased burden of macrovascular disease in type-2 diabetes and provided the incidence rates of various diseases. 6.3 Objectives of the study To detect peripheiral vascular disease in type-2 diabetes mellitus using ankle brachial index To correlate the findings of ankle brachial index with duration of diabetes and coronary artery disease 7. Materials and methods 7.1 Source of Data Randomly selected 100 cases of Type 2 diabetes mellitus will studied, which will be admitted to medical wards at Basaveshwara Teaching and General Hospital, Gulbarga attached to Mahadevappa Rampure Medical College Gulbarga. 7.2 Methods of collection of data(including sampling) 1. Place of study : Department of Medicine, Basaveshwara Teaching and General Hospital, M.R. Medical College, Gulbarga 2. Duration of study : 18 months(Dec 2012-May 2014) 3. Sample size : 100 Inclusion Criteria- 1) A diagnosis of type 2 diabetes mellitus as per WHO criteria. 2) Treatment with dietary restrictions and / or oral hypoglycaemic agents and / or insulin for at least 6 months. Exclusion Criteria- Patients with the following conditions, which would interfere with the measurement of the ankle brachial index, were excluded: 1) Trauma, surgery or amputation involving the lower limb 2) Leg ulcers 3) Deep vein thrombosis 4) Filariasis or lower limb swelling due to other causes which would impair Doppler image quality. 7.3 Does the study require any investigations or interventions to be conducted on Patients or other humans or animals? If so please describe briefly. Yes INVESTIGATIONS CBC, ESR, FBS, PPBS, HBA1C, FASTING LIPID PROFILE, FUNDOSCOPY, URINE ROUTINE, ECG, ECHOCARDIOGRAPHY and DOPPLER SCAN OF LOWER LIMBS 7.4 Has ethical clearance been obtained from institution in case of 7.3? Yes, ethical clearance has been taken from “Ethical Clearance Committee” of the institution. 8 References Hooi JD, Kester AD, Stoffers HE, Overdijk MM, van Ree JW, Knottnerus JA. 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Medical COLLEGe, GULBARGA-585105 11.2 Signature 11.3 Co-guide DR.Chetan S. Durgi MD Professor, DEPARTMENT OF RADIODIAGNOSIS, M.R.MEDICAL COLLEGE , GULBARGA- 585105 11.4 Signature 11.5 Head of the Department DR.G.VEERANNA MD,DM(CARDIOLOGY) PROFESSOR AND HOD DEPATMENT OF MEDICINE M.R.MEDICAL COLLEGE , GULBARGA – 585105 11.6 Signature 12 12.1 Remarks of the chairman and principal 12.2 Signature