SYNOPSIS



SYNOPSIS

Rajiv Gandhi University of Health Sciences, Karnataka,

Bangalore.

“OCCURENCE AND PATTERN OF DYSLIPIDEMIA IN

NEWLY- DETECTED TYPE 2 DIABETES MELLITUS AND

ITS CORRELATION WITH ANTHROPOMETRIC PARAMETERS”

Name of the candidate : Dr. Cynthia Amrutha Sukumar

Guide : Dr.(Col) R. Arunachalam

Co-Guide : Dr. Sudeep K.

Course and Subject : M.D (General Medicine)

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Department of General Medicine,

Father Muller Medical College,

Kankanady, Mangalore – 575002.

August – 2012

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

PROFORMA FOR REGISTRATION OF THE SUBJECT FOR

DISSERTATION

|1. |NAME OF THE CANDIDATE AND ADDRESS |DR. CYNTHIA AMRUTHA SUKUMAR |

| | |P.G. RESIDENT |

| | |FR. MULLER MEDICAL COLLEGE, KANKANADY, |

| | |MANGALORE – 575002. |

|2. |NAME OF THE INSTITUTION |FR. MULLER MEDICAL COLLEGE, KANKANADY, |

| | |MANGALORE – 575002 |

|3. |COURSE OF STUDY AND SUBJECT |M.D. (GENERAL MEDICINE) |

|4. |DATE OF ADMISSION TO COURSE |30-05-2012 |

|5. |TITLE OF THE TOPIC: |

| |OCCURENCE AND PATTERN OF DYSLIPIDEMIA IN NEWLY- DETECTED TYPE-2 DIABETES MELLITUS AND ITS CORRELATION WITH ANTHROPOMETRIC PARAMETERS. |

|6. |Brief Resume of the Intended Work: |

| |6.1. Need for the study: |

| |Diabetes is an iceberg disease. Currently, India has a diabetic burden of |

| |40.9 million (2006) and is called the “Diabetic capital of the world”. Type-2 diabetes mellitus constitutes 95% of the diabetic population in India. This |

| |escalating epidemic of type 2 DM has been attributed to increasing obesity and longevity1. |

| |Macrovascular complications in type-2 DM are coronary artery disease, cerebrovascular accidents and peripheral vascular disease which are major causes of |

| |morbidity and mortality in type 2 DM. Altered lipid metabolism and abnormal lipid levels are major contributors to macrovascular diseases. Despite its |

| |enormous global importance, accurate population-based data with specific dyslipidemic pattern for the Asian population are lacking 2. |

| |Because of the additive cardiovascular risk of hyperglycemia and hyperlipidemia, lipid abnormalities should be aggressively detected and treated as a part |

| |of comprehensive diabetic care. |

| |In view of this, the current study aims at detecting the occurence and pattern of dyslipidemia in newly-detected type-2 diabetic patients in Father Muller|

| |Medical College Hospital. An effort will also be made to relate the dyslipidemia to anthropometric parameters. |

| |6.2 Review of Literature |

| |Macroangiopathic complications (attributed mainly to dyslipidemia) refer to adverse cardiovascular events arising from atherosclerosis. Patients with type |

| |2 DM are at a |

| |2- 4 fold higher risk of macrovascular complications 3. |

| |Smoking, hypertension, obesity and dyslipidemia have been shown to play a major role in the pathogenesis of atherosclerosis. |

| |Atherosclerosis in diabetics affects all the parts of the vascular tree and is morphologically and biochemically identical to that in non-diabetic |

| |subjects. However, the atherosclerosis is premature, more extensive and has accelerated progression in diabetics4. |

| |Patients having one or more lipid abnormalities (TG,cholesterol or LDL chlesteerol) outside the targets recommended by the American Diabetic Association |

| |(ADA) are considered to have dyslipidemia, which includes TG ≥150mg/dl, |

| |cholesterol ≥200 mg/dl, LDL ≥ 100 mg/dl, HDL ≤ 40 mg/dl in males and ≤ 50 mg/dl in females . |

| |In Indian diabetics,the most common dyslipidemia noted is the combined dyslipidemia which manifests as increased LDL and decreased HDL in men and women. |

| |The prevalence of dyslipidemia among Indian diabetics is 85.5% in males and 97.8% in females. However , the consequences of atherosclerosis in the Asian |

| |Indian population are more severe and develops earlier in life 5. |

| | |

| | |

| |Normally, LDL receptors are stimulated by insulin, the lack of which will result in accumulation of plasma LDL which progresses to reach atherogenic |

| |levels. Atherosclerotic changes are initiated by oxidized LDL and not naïve LDL. Both HDL and anti-oxidants impair this process of LDL oxidation thereby |

| |exerting |

| |anti-atherogenic action 4. |

| |Obesity and overweight in adults reflects a risk for type 2 DM and cardiovascular risk in the future. Common surrogate measures of obesity are Body mass |

| |index (BMI) |

| |and Waist circumference (WC). |

| |A study done in Karnataka, to assess the lipid abnormalities in normal healthy subjects and in type 2 DM subjects showed significantly elevated total |

| |cholesterol, triglycerides and reduced HDL levels in the diabetic group6. |

| | |

| |6.3 Objective of the study: |

| |To study the occurrence of dyslipidemia in newly-detected type-2 diabetics. |

| |To analyse the pattern of dyslipidemia in this group. |

| |To assess the relationship between anthropometric measurements and dyslipidemia. |

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|7 |Materials and Methods |

| |7.1 Source of data: |

| |A minimum of 50 patients (male and female) seeking medical attention at the Father Muller Medical College Hospital, during the period of study ,who have |

| |been newly-diagnosed to have type 2 DM will be included in this study. |

| |7.2. Method of collection of data( including sampling procedure if any): |

| |This cross-sectional study is proposed to be conducted at the Father Muller Medical College Hospital. After fulfilling the criteria in the study, a |

| |voluntary informed consent will be obtained from all the study subjects. Each of the subjects will be initially evaluated for BMI, WC and clinical features|

| |of dyslipidemia (which include arcus senilis ,xanthelasma and xanthomas). A detailed clinical evaluation including history and physical examination will be|

| |done on each subject. |

| |Body-weight will be recorded while standing motionless on a digital weighing scale( to the nearest 0.1 kg). Height will be measured while standing erect |

| |against a vertical scale of a portable stadiometer (to the nearest 0.1 cm). BMI will then calculated as weight in kilogram divided by squared height in |

| |meter. |

| |Waist circumference will be measured midway between iliac crest and lowermost margin of ribs at minimum respiration. Optimum cut-offs for Asian Indians |

| |will be applied to the obtained values7. |

| |BMI- Normal BMI: 18.0-22.9 kg/m2 |

| |Overweight:23.0-24.0 kg/m2 |

| |Obesity :>25 kg/m2 |

| |Waist circumference- 90 cms(men) and 80 cms (women) |

| |Clinical features of dyslipidemia included in this study will be arcus senilis, Xanthelasma and xanthomas. |

| |Fasting peripheral venous blood samples will be obtained for estimation of fasting blood sugar levels and serum lipid estimation |

| |(S.triglycerides,S.cholesterol,S.HDL and S.LDL) . Venous blood samples will also be obtained for glycosylated-Hb, post-prandial blood sugar, renal |

| |function test(S.Creatinine) and liver function test(SGPT/SGOT). Wherever there is a clinical suspicion of hypothyroidism, serum TSH will be done. Urine |

| |microscopy and urine albumin-creatinine ratio will be obtained in all subjects.All patients will be subjected to a fundoscopic evaluation to evaluate for |

| |diabetic retinopathy. |

| | |

| |Sample size: |

| |Fifty patients who have been newly-diagnosed to have type-2 DM will be included in this study. |

| | |

| |Design of the study: |

| |Cross-sectional descriptive study. |

| | |

| |Duration of the study: |

| |The study period will be 18 months. |

| |Inclusion Criteria : |

| |Patients fulfilling the ADA criteria for diagnosis of type 2 DM who are- |

| |Newly-diagnosed type-2 diabetics |

| |>20 years of age |

| |Exclusion Criteria: |

| |Acute metabolic complications |

| |Diabetic ketoacidosis |

| |Hyperglycemic hyperosmolar syndrome |

| | |

| |Acute illnesses |

| |Acute Myocardial Infarction |

| |Cerbrovascular accidents |

| |Acute infections |

| | |

| |Alcohol Dependance( according to the ICD-10 criteria) |

| |Hypothyroidism |

| |(clinical/abnormal thyroid function test/on thyroid replacement therapy) |

| |Liver disorders ( clinical findings/ > 3-4 times upper limit of normal LFT) |

| |Renal disease (of non-diabetic etiology) |

| |Known inherited disorders of lipids |

| |Secondary dyslipidemia |

| |Pregnancy |

| |Drugs |

| |Beta-blockers |

| |Thiazides |

| |Steroids |

| |Hypolipidemic drugs |

| |Oral contraceptives |

| |Anti -coagulants |

| |Data Analysis |

| |The data obtained will be collected and the occurence and pattern of dyslipidemia will be studied. Further, its relation with the obtained anthropometric |

| |measurements will be analysed by frequency,percentage,mean,standard deviation and chi-square test. |

| | |

| |7.3 Does the study require any investigation/ intervention on patients/other humans. If so, describe briefly: |

| | |

| |Blood and urine tests as enumerated in “Methods of Study” will be done in all subjects. |

| | |

| |7.4 Has ethical clearance been obtained from your institution in case of 7.3: |

| |YES |

| | |

| | |

|8. |References: |

| |1.Mohan V, Sandeep S, Deepa R, Shah B, Varghese C. Epidemiology of type-2 diabetes:Indian scenario. Indian J Med Res 2007; 125:217 -30. |

| |2.King H, Rewers M .Global Estimates for the prevalence of diabetes mellitus and impaired glucose tolerance in adults. Diabetes Care 1993;16:157-77. |

| |3.Huxley R, Barzi F, Woodward M. Excess risk of coronary artery disease associated with diabetes in men and women: meta-analysis of 37 prospective cohort|

| |studies. BMJ 2006; 33:73-8. |

| |4.National Diabetes Data Group. Classification and diagnosis of diabetes mellitus and other categories of glucose intolerance. Diabetes 1979;28:1039-57. |

| |5.Parikh RM, Joshi SR, Menon PS, Shah NS. Prevalence and pattern of diabetic dyslipidemia in Indian type-2 diabetic patients, Diabetes Metab Syndrome |

| |2010; 4(1):10-12. |

| |6.Rai N, Jeganathan PS. A correlative study of status of serum cholesterol, triglyceride and HDL-cholesterol in Type-2 diabetes mellitus patients with |

| |and without hypertension. Research J of Pharmaceutical, Biological and Chemical Sciences 2010; 1(3):377 –81. |

| |7.Misra A, Chowbey PS, Makkar BM, Wasir JS, Chadha D, Joshi SR, et al'. Consensus statement for diagnosis of Obesity,Abdominal Obesity and the metabolic |

| |syndrome for Asian Indians and Recommendations for Physical Activity,Medical and Surgical Management. J Assoc Physicians India 2009;57:163-70. |

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|9 |SIGNATURE OF THE CANDIDATE - | |

|10. |REMARKS FROM GUIDE- | |

|11. |11.1 NAME & DESIGNATION OF |DR. (Col) R. ARUNACHALAM, MD |

| |GUIDE |PROFESSOR AND UNIT HEAD, |

| | |DEPARTMENT OF GENERAL MEDICINE |

| | |FR. MULLER MEDICALCOLLEGE |

| | |MANGALORE – 575002 |

| |11.2 SIGNATURE | |

| |11.3 NAME AND DESIGNATION OF |DR. SUDEEP K, MD. DNB(ENDOCRINOLOGY), ASSISTANT PROFESSOR , |

| |CO-GUIDE |DEPARTMENT OF GENERAL MEDICINE |

| | |FR. MULLER MEDICALCOLLEGE |

| | |MANGALORE – 575002 |

| |11.4 SIGNATURE | |

| |11.5 HEAD OF DEPARTMENT |DR. NARASIMHA HEGDE , MD |

| | |PROFESSOR AND HOD OF MEDICINE |

| | |DEPARTMENT OF GENERAL MEDICINE |

| | |FR. MULLER MEDICAL COLLEGE |

| | |KANKANADY, MANGALORE – 575002 |

| |11.6 SIGNATURE | |

|12 |12.1 REMARKS OF THE CHAIRMAN AND DEAN | |

| | | |

| |12.2 SIGNATURE | |

|9 |SIGNATURE OF THE CANDIDATE - | |

|10. |REMARKS FROM GUIDE- | |

|11. |11.1 NAME & DESIGNATION OF |DR. (Col) R. ARUNACHALAM, MD |

| |GUIDE |PROFESSOR AND UNIT HEAD, |

| | |DEPARTMENT OF GENERAL MEDICINE |

| | |FR. MULLER MEDICALCOLLEGE |

| | |MANGALORE – 575002 |

| |11.2 SIGNATURE | |

| |11.3 NAME AND DESIGNATION OF |DR. SUDEEP K, MD. DNB(ENDOCRINOLOGY), ASSISTANT PROFESSOR , |

| |CO-GUIDE |DEPARTMENT OF GENERAL MEDICINE |

| | |FR. MULLER MEDICALCOLLEGE |

| | |MANGALORE – 575002 |

| |11.4 SIGNATURE | |

| |11.5 HEAD OF DEPARTMENT |DR. NARASIMHA HEGDE , MD |

| | |PROFESSOR AND HOD OF MEDICINE |

| | |DEPARTMENT OF GENERAL MEDICINE |

| | |FR. MULLER MEDICAL COLLEGE |

| | |KANKANADY, MANGALORE – 575002 |

| |11.6 SIGNATURE | |

|12 |12.1 REMARKS OF THE CHAIRMAN AND DEAN | |

| | | |

| |12.2 SIGNATURE | |

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