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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA BANGALORE PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1. Name of the Candidate Address (In Block Letters) ADARSH.V.B S/O CHANDRASHEKHAR RAMPURE COLONY H. NO. 9-10-21 BVB COLLEGE ROAD BIDAR KARNATAKA 2. Name of the Institution MVJ MEDICAL COLLEGE & RESEARCH HOSPITAL, HOSKOTE, BANGALORE 3. Course of study and subject M.D. (GENERAL MEDICINE) 4. Date of admission to course 5. Title of the topic 22.05.2008 EVALUATION OF GALLBLADDER VOLUME IN DIABETICS BY ULTRASONOGRAPHY 6. Brief resume of the intended work: 6.1 Need for the study: Diabetes Mellitus is most common endocrine disorder in humans characterized by metabolic abnormalities leading to long term complications involving kidney, G.I.T, nerves and vessels. Various studies point towards the increased prevalence of gall bladder diseases in diabetics. This has been attributed to cholecystomegaly & impaired gall bladder contraction, mainly due to autonomic neuropathy seen in diabetics. Though gall bladder stasis is the most necessary prerequisite for gall stone formation, other risk factors include sex, genetic factors, obesity, parity, diet, drugs and hyperlipidemia. 6.2 Review of literature: 1. A.K.Agarwal, S.Miglani, S.Singla et al conducted a randomized study on 91 diabetic patients enrolled in Diabetic Clinic of Dept. of Medicines, Dr. Ram Manohar Lohiya Hospital, New Delhi to determine the gall bladder volume in diabetic patients, its comparison with control group, its correlation with age, sex, body mass index, parity, hyperlipidemia and autonomic neuropathy by using real time ultrasonography and concluded that cholosystomegaly to a significant degree was found in Type 2 diabetic patients. When Type 2 diabetics were sub grouped according to presence of autonomic neuropathy, higher gall bladder volumes were seen in patients with autonomic neuropathy. 2. S.Singh, R.Chandar, A.Singh et al conducted a randomized prospective study at Govt. Medical College, GND Hospital, Amritsar, to determine gall bladder volume in Type 2 diabetic patients, comparison of gall bladder disorders in patients with or without autonomic neuropathy as well as normal individuals. For the study 50 diabetic patients, out of which 25 had autonomic neuropathy, and 25 without autonomic neuropathy and 25 healthy non diabetic are matched (age, sex). Ultra sonography abdomen was performed to measure size of gall bladder, gall bladder thickness, presence of gall stones, gall bladder volume was calculated by ellipsoid method. Results: Fasting gall bladder volume in diabetics with autonomic neuropathy was found to be higher than that of controls. 3. Guliter.S, Yilmaz.S, Karakan.T Dept. of Gastroentorology, University of Kirikkale Faculty of Medicine, Turkey conducted a randomized study to determine gall bladder volume and prevalence of cholelthiasis in diabetic patients especially in a group of patients with NIDDM. For the study 41 males and 47 females of NIDDM with mean age 53.5 +/- 11 were compared with control group, which included health volunteers 33 males and 34 females mean age 50.3 +/- 18 years, all patients investigated after 12 hours of fasting & 30 min after standard test meal. Pre-meal & post-meal gall bladder volumes were used for calculation of the ejection fraction and gall bladder volume. The study concluded that increasing gall bladder and impaired ejection fraction in NIDDM patients. This may be the initiator of bile stasis in the gallbladder & subsequent cholesterol crystal formation. 4. Raman.P.G., Patel.A, Mathew.V Dept. of Medicine, MGM Medical College & MY Hospital, Indore conducted a randomized study to know the prevalence of gall bladder disorder in Type 2 diabetic patients and their correlation with patient factors like age, sex, weight, duration of diabetics and autonomic neuropathy. For the study 50 Type 2 diabetics and 30 healthy controls underwent real time ultrasonography. The fasting gall bladder volume and contraction 60 minutes after a fatty meal of the study group and controls were compared. The study concluded that type 2 diabetics have increased prevalence of gall bladder disorder attributed to autonomic neuropathy leading to increased fasting gall bladder volume. 5. Kayacetin, Guracan Kisakol et al Selcuk University, Meram Medical faculty, Dept. of Internal Medicine, Division of Gastro Enterology, Turkey conducted a randomized study on 51 diabetics and 28 controls to determine gall bladder volume, function and its relationship with peripheral and autonomic neuropathy. They measured fasting and post prandial gall bladder volume and ejection fraction by a real time ultrasonography. The study concluded that no significant difference in biochemical parameters between diabetics and control group could be found, but fasting gall bladder volumes were higher in diabetic group compared to control group. 6. Chapman.T.M, Chapman.B.A, Frampton.C.M et al conducted a study at Netherlands to know whether diabetics have increased gall bladder volume that would predispose to stasis, nucleation of cholesterol crystals. For the study 271 diabetics and 271 normal controls were chosen. Gall bladder volume determined by real time ultrasonography and ellipse formula. The study concluded that there is significance difference between IDDM and NIIDM. NIIDM is independent predictor of increased gall bladder volume. 6.3 7. Objective of the study 1. To determine the Gall bladder volume in diabetic patients. 2. Comparison of gall bladder volume in both study group and control group. 3. Correlation of gall bladder volume in diabetics with parameters such as age, sex, body mass index, parity, hyperlipidemia and autonomic neuropathy. 4. Correlation of gall bladder volume with duration of diabetes. Material and methods 7.1 Source of Data: M.V.J Medical College & Research Hospital falling into the inclusion criteria of the present study. 7.2 Method of collection of data A study group of 100 patients (50 males and 50 (including sampling procedure, if females) , the diagnosis of diabetes in these any): patients is in accordance with WHO criteria, i.e. fasting blood glucose concentration >/=126mg/dl and >/=200mg/dl 2hrs after ingestion of standard test meal 75gm of carbohydrate load. 50 healthy (25 males and 25 females), nonpregnant volunteers without gastrointestinal, renal and cardiac diseases were recruited to control group, after obtaining informed consent. USG abdomen will be done for both study and control group, in both fasting level and after ingestion of standard test meal. The data will be analysed by dividing the study group into two groups i.e., Type 1diabetes and Type 2 diabetes, all relevant details including history, examination, investigations, etc. were enlisted in the proforma. The gall bladder volumes in study group will be compaired with age and sex matched healthy volunteers. Correlating the gall bladder volume with parameters such as age, sex, body mass index, parity, hyperlipidemia and autonomic neuropathy and with duration of diabetes. 7.3 Does the study require any investigation or interventions to be conducted on patients or other human or animals? If so, please describe briefly. 7.4 Has ethical clearance been obtained from your institution in case of 7.3 8. Inclusion Criteria : Duration of diabetes > 5 years Functioning gall bladder No evidence of gastro intestinal and hepato biliary disease Exclusion Criteria: Diabetic patients taking antihypertensive drugs which interferes with autonomic functions Those with history of major cardiac arrhythmias Obese subjects ( BMI >25) Pregnant ladies With history of CVA Yes Fasting blood sugar levels Post prandial blood sugar levels Glycosylated Hb Serum lipid profile Microalbuminuria Ultrasonography YES List of references: 1) A.K.Agarwal, S.Miglani, “Evaluation of gall bladder volume in diabetics by ultrasonography” J Assoc Physicians India 2004;52:962-5 2) S.Singh, R.Chandar, A.Singh, “Ultrasonographic evaluation of gall bladder diseases in diabetes mellitus type 2” Ind J Radiol Imag 2006 16:4:505-508 3) Guliter.S, Yilmaz.S, Karakan.T, “Evaluation of gall bladder volume in NIDDM using ultrasonography” J Clin Gastroenterol 2003 Oct, 37(4), 288-91 4) Raman.P.G, Patel A, Mathew.V “Gall bladder disorder and type 2 diabetes mellitus – a clinical base study” JAPI 50: 887-889, 2002 5) Kayacetin, Guracan Kisakol, “Real time sonography for screening of gall bladder motility in diabetic patients: relation to autonomic and peripheral neuropathy ”, NEL 2003; 24:73–76 6) Chapman.T.M, Chapman.B.A, Frampton.C.M, “Gall bladder volume (comparison of diabetes and controls)” Dig Dis Sci 1998 Feb;43(2):344-8. 9. Signature of the Candidate 10. Remarks of the Guide Diabetes mellitus , which is the most common endocrine disorder leads to various long term complications affecting the kidney, GIT, heart, nervous system & peripheral vascular system. Gall bladder is increasingly affected in diabetes mellitus as a long term complication as shown in various studies. There is cholecystomegaly and impaired gall bladder contraction essentially due to autonomic neuropathy seen in diabetics. By using real time ultrasonography, gall bladder volume and impaired contraction can be studied. The study will provide the exact incidence and the nature of gall bladder pathology. 11. Name & Designation of (in block letters) 11.1 Guide Dr. P.V. VENKATARAMANAPPA, M.D. PROFESSOR, DEPT. OF MEDICINE, MVJ MEDICAL COLLEGE & RESEARCH HOSPITAL, HOSKOTE, BANGALORE 11.2 Signature 11.3 Co-Guide (if any) 11.4 Signature Dr. GEETHA S. SHANKAR PROFESSOR, DEPT. OF RADIOLOGY, MVJ MEDICAL COLLEGE & RESEARCH HOSPITAL, HOSKOTE, BANGALORE 11.5 Head of Department DR.K.S.KESHAVA, M.D PROFESSOR & HOD, DEPARTMENT OF MEDICINE, MVJ MEDICAL COLLEGE & RESEARCH HOSPITAL, HOSKOTE, BANGALORE 11.6 Signature 12. 12.1 Remarks of the chairman & principal 12.2 Signature