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DR - Muddassir Final Synopsis..
DR - Muddassir Final Synopsis..
E UNIVERSITY BIJAPUR, KARNATAKA PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION TITLE OF THE TOPIC A STUDY OF DISTRIBUTION OF ABO BLOOD GROUPS AMONG PATIENTS WITH DIABETES MELLITUS AND THEIR SECRETOR STATUS DR. MUDDASER MUJAWAR PG IN MEDICAL PHYSIOLOGY (M.Sc MEDICAL PHYSIOLOGY)
UNDER THE GUIDANCE DR.MANJUNATHA. AITHALA. PROFESSOR AND HEAD OF DEPARTMENT OF PHYSIOLOGY
A STUDY OF DISTRIBUTION OF ABO BLOOD GROUPS AMONG PATIENTS WITH DIABETES MELLITUS AND THEIR SECRETOR STATUS
7.
BRIEF RESUME OF THE INTENDED WORK. 6.1 NEED FOR THE STUDY 6.2 REVIEW OF LITERATURE 6.3 OBJECTIVES OF STUDY MATERIALS AND METHODS 7.1 SOURCE OF DATA ANNEXURE-II ANNEXURE-I ANNEXURE-I ANNEXURE-I
7.2 METHOD OF COLLECTION OF DATA 7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTION TO BE CONDUCTED ON PATIENTS, HUMANS OR ANIMALS. IF SO PLEASE DESCRIBE BRIEFLY. 7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3 ANNEXURE-II ANNEXURE-II ANNEXURE-II
8.
LIST OF REFERENCES
ANNEXURE-III
9.
11 NAME AND DESIGNATION . 11.1 GUIDE DR. MANJUNATHA. AITHALA. M.D.PHYSIOLOGY PROFESSOR AND HEAD DEPARTMENT OF PHYSIOLOGY
11.2 SIGNATURE
DR. MANJUNATHA. AITHALA. M.D.(MEDICAL PHYSIOLOGY) PROFESSOR AND HEAD DEPARTMENT OF PHYSIOLOGY
11.4 SIGNATURE
12.2 SIGNATURE
ANNEXURE I
6. Brief resume of the intended work
In the genetics of the secretor system two options exist. A person can be either a Secretor (Se) or a Non-secretor (se). This is completely independent of whether an individual is a blood type A, B, AB, or O. This means that someone can be an A Secretor or an A Non-secretor, a B Secretor or a B Non-secretor etc.
6
In a simplified sense, A Secretor is defined as a person who secretes his blood type antigens into body fluids and secretions like the saliva in mouth, the mucus in digestive tract and respiratory cavities, etc. Basically what this means is that a secretor puts his/her blood type into these body fluids. A Non-secretor on the other hand puts little to none of his/her blood type into these same fluids. As a general rule, in the U.S. about 80% of the population are Secretors remaining 20% are Non-secretors. 6
Despite the fact that the association of blood groups with certain diseases is clearly demonstrated, and the evidence that blood groups may play an important role in certain diseases, for example, peptic ulcer and gastric cancer, some other studies report no association between ABO blood group with those diseases, including DM. It is not surprising that the data on association of diabetes with ABO blood groups is scanty and mostly shows no association. However, there is evidence of positive association as well. In addition, it was found that the A blood group appears with the highest frequency among Malay healthy controls, but in Indians blood group B is the most dominant. In a recent study,it was found that blood group B was prevalent at a high percentage among patients with DM type 2 35.71% in comparison to that of controls, 22.52%, but there was no statistically significant difference (P>0.05).
So, it was concluded that there is an association between blood groups A and O and DM type 2 and the association is negative as these groups are less common in diabetics and seems to be protective from the disease. Large studies in other ethnic groups are needed to confirm these results. Hence undertaken. the study has been
ANNEXURE I
6.2
Review of Literature:
A study conducted in Bangladesh with a sample size of 2,312 patients and 8,936 controls that there was no association between ABO blood groups and DM. But results show a significantly lower percentage of O and A blood groups among diabetic patients, which means a negative association with these blood groups. A larger sample study will be needed in our population to further investigate this finding. A study carried out in India included 511 patients with DM type 2 in Madhya Pradesh. The samples represented adequately the Brahmin (n=146), Bania (n=127), Kayasth (n=52), Shudra (n=59), and Muslim groups (n=51). In total, 475 unrelated normal healthy individuals were sampled randomly from the same area, matching age, sex, socio-economic status, etc., but not the disease condition. For the ABO blood types, standard serological procedures were followed. Statistical analysis was done using the Chisquare test and the findings suggested that there was no association between the ABO . 7 In 2009, a study was conducted to show interrelationship between DM type 2 and ABO blood groups. It was found that among 70 patients with DM, blood group B was more common and represented 35.71% compared to that of control, which represented only 22.14% of the sample population, but statistical significance was not achieved. 7 A study was conducted to show the frequencies of blood groups A and B & differences between populations. The observations raised fundamental questions regarding the causes of these differences. From another study it was suggested that P falciparum was in the right position during evolutionary history to affect the origin and relative proportion of ABO antigens; that the geographic distribution of ABO antigens worldwide is consistent with a survival advantage in malaria among group O individuals; 9 10
A study was conducted to determine the frequency of ABO and Rhesus (Rh) blood groups in Pakistan. It was a cross sectional prospective study and was conducted over a period of one year. 8 Out of 22897 subjects 17141 (74.86%) were male subjects and 5756 (25.140%) were female. Out of 17141 male subjects 15597 (90.99%) and out of 5756 female
subjects 5040 (87.56%) were found to be Rh-positive. The frequency of Rh-negative group in male subjects were (9.01%) where as in female subjects were (12.22%). The frequency of A, B, O and AB groups in Rh-positive male subjects were 25.63%, 29.54%, 26.04% and 9.78%, amongst female subjects, it was 24.53%, 28.06%, 25.54% and 9.43% respectively. In Rh-negative male subjects the frequency of A, B, O and AB is 2.25%, 2.88%, 3.01% and 0.88%, while amongst females it is 3.54%, 4.24%, 3.74% and 0.92% respectively. 8 It was concluded from this study that frequency of Rh-positive blood group was B, O, A, and AB in both gender, where as the most common Rh-negative in male and female subjects are O, B, A, AB, and B, O, A, and AB respectively.8 A study was conducted in Non-O blood groups subjects and demonstrated particularly high risk of severe malarial anemia (e.g. blood group A: case-control OR 1.54, CI 1.22 1.96, P = 0.00039; family OR 1.51, CI 1.09 2.09, P = 0.014). The higher risk of SA experienced by individuals with non-O blood groups may reflect a pathophysiological effect, for example accelerated clearance of erythrocytes bound to iRBC. 9 The analysis strongly supported the hypothesis that blood group O individuals are relatively protected from severe malaria in comparison to other blood groups, particularly blood group A and AB. 9
A study was carried out to show Heretability of diabetes mellitus in Ethiopian diabetics in prospective case control study of 859 diabetic probands and 1059 non-diabetics controls. There were 445 non-insulin dependent diabetic mellitus ( NIDDM ) and 414 insulin dependent diabetes mellitus ( IDDM), in the diabetic probands. The study indicated that, heredity plays an important role in genesis of diabetes mellitus. 11
From the above observations it appears that there is variation in difference in the relationship between blood groups, secretor status and their susceptibility to diseases . Lokking at the heterogenecity of the results, it is exceedingly difficult to arrive at the cause effect relationship of blood groups and diabetes mellitus . It is also extremely difficult to explain in what way, the ABO antigens offer protection or make persons more susceptible to disease. What is certain from the family and blood group studies is that heredity plays an important role in aetiology of diabetes mellitus.
Thus as mentioned previously, in the aetiology that genetic inheritance of diabetes is accepted most widely, it then appears that , the genes for ABO blood groups and secretor Se genes along with the other genetic and environmental factor might influence the degree of penetrance of a gene or genes responsible for diabetes mellitus.
The above reviews reveal that , there is a sizeable proportion of evidence for association between blood group antigens, secretor status and diabetes mellitus, from various parts of the world. However , there are very few reports involving subjects of Indian origin in this field. This warrants a study to be conducted to know the association between blood group antigens, secretor status and diabetes mellitus involving subjects of Indian origin.
ANNEXURE I
ANNEXURE-II
METHODOLOGY
7.2 Method of collection of Data Study group: This group will consist of specific group of patients suffering with
either Type I or Type II Diabetes Mellitus and attending Medical OPD and admitted patients in medical wards in BLDEUs SHRI B. M. Patil Medical College and Hospital in Bijapur. The patients are in age group of 17-65 yrs with confirmed Diabetes Mellitus. Study group includes both male and females subjects.
Control group: Normal healthy subjects attending Diabetic clinic in the BLDEUs
SHRI B. M. Patil Medical College and Hospital in Bijapur, will be selected for the control group.
Age of the subjects: In both the groups, subjects are in the age group of 17-65
years will be included.
Size of sample: Both the control and study groups consisted of 110 subjects (55
subjects each) Sample size is calculated by assuming the error +2.53, by using the formula
n={ z /2 }2 E
Where z/2 = Value of Z at /2 % level of significance = Standard Deviation E = Permissible error
2) Determination of ABO and Rh blood group 3) Determination of Secretor and Non-secretor status
Inclusion criteria:
1. Only healthy subjects without any family history of diabetes mellitus and known chronic disease will included in the study as control group. 2. Established diabetic patients of both type I and type II will be included in study group. 3. Confirmed diabetic patients whose blood sugar level will be controlled on taking oral hypoglycaemic drugs or insulin will be included in the study group.
Exclusion criteria:
1. Subjects with malignancies like leukemia which leads to weakning or loss of blood group antigens on cell. 2. Subjects associated with B antigen like activity. 3. Subjects with history of recently transfused non-specific group blood and bone marrow transplantation leading to presence of 2 separate cell population. The following parameters will be recorded in the subjects: I.Record of Physical Anthropometry of subjects. 1. Height (in centimetres): This will be measured with subject standing without their footwears nearest to 0.1 centimetres. 2. Weight (in kilograms): The subjects will be weighed in standardized machine with minimum clothing nearest to 0.1 kilogram. 3. Chest circumference: It will be measured at deep inspiration position at the level of the nipple with minimum clothing with the help of standard tailor gram negative septicaemia, intestinal
tape nearest to 0.1centimetre. 4. Body Mass Index (kilogram/meter2): This is calculated for each subject from weight in kgs and height in meters by using Quetlet index. II. Record of physiological parameters.
1. Pulse rate: It will be expressed as beats per minute by palpating right radial artery. 2. Blood pressure (SBP and DBP): It will be measured by mercury sphygmomanometer in mm of Hg. 3. Respiratory rate: It will be expressed as cycles per minute by manual method. 4. Mean arterial pressure (MAP): It will be measured in mm of Hg by using the following formula = DBP+1/3 pulse pressure (PP). III. Method of Assesing secretory status The presence of blood group antigens in the saliva of the subjects of both groups will be tested by using Haemaglutination Inhibition Technique.
Statistical Analysis: Statistical analysis is done using Chi Square test for finding the presence of an association between attributes like blood groups,secretor status, sex etc.. The results are presented using bar diagrams.
a. Diagrammatic representation. b. Mean +/- Standard Deviation c. Chi square test. d. Correlation and Regression analysis.
7.3. Does the study require any investigation or intervention to be conducted on workers or other human or animals? Yes. The study requires recording of various physical and physiological parameters, as well as determination of ABO, Rh blood group & Secretor status. However, none of these are invasive and none will interfere with the normal physiology of the subjects. For this, an informed consent will be obtained from each subject (Format enclosed in Annexure IV).
7.4 Has ethical clearance been obtained from your institution in case of 7.3? To be taken.
ANNEXURE-IV
B. L. D. E. U SHRI B.M. PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, BIJAPUR RESEARCH INFORMED CONSENT FORM
BLOOD GROUPS AMONG PATIENTS WITH DIABETES MELLITUS AND THEIR SECRETOR STATUS
PROF AND HEAD DEPARTMENT OF PHYSIOLOGY 1: PURPOSE OF RESEARCH: I have been informed that this study will test relationship between Blood group, secretory status of the subject to his/her Diabetes mellitus. This study will be useful academically as well as to find out association between Blood group, secretory status and Diabetes mellitus in patients and normal subjects of both sexes. 2: PROCEDURE: I understand that, the procedure of the study will involve determination of my blood groups, secretor status and diabetic status. Procedure is diagnostically invasive in nature. (Collection of blood sample ) The procedure will not interfere with any of my physiological parameters and they are non invasive.
3: RISK AND DISCOMFORTS: I understand that, determination of my blood groups, secretor status and diabetic status will not cause any discomfort to me and do not involve any risk to my health. 4: BENEFITS: I understand that my participation in the study may not have a direct benefit to me but this may have a potential beneficial effect in the field of Diabetes mellitus in future. 5: CONFIDENTIALITY: I understand that medical information produced by this study will become part of institutional records and will be subject to the confidentiality and privacy regulation of the said institute. Information of a sensitive personal nature will not be a part of medical record, but will be stored in investigators research file and identified only by a code number. The code key connecting name two numbers will be kept in a separate secured location.
If the data to be used for publication in the medical literature and for teaching purpose no names will be used and other identities such as photographs, audio and video tapes will be used only with my special written permission. I understand I may see the photographs and the video tapes and have the audio tapes before giving this permission. 6: REQUEST FOR MORE INFORMATION: I understand that I may ask more questions about the study at any time. Concerned researcher is available to answer my questions or concerns. I understand that I will be informed of any significant new findings discovered during the course of this study which might influence my continued participation. If during the study or later, I wish to discuss my participation in all concerns regarding this study with a person not directly involved, I am aware that the social worker of the hospital is available to talk with me. A copy of this consent form will be given to me to keep for careful re-reading.
7: REFUSAL OR WITHDRAWAL OF PARTICIPATION: I understand that my participation is voluntary and may refuse to participate or may withdraw my consent and discontinue participation in the study at any time without prejudice to my present or future care at this hospital. I also understand that researcher may terminate my participation in this study at any time after she/he has explained the reasons for doing so and had helped arrange for my continued care by my physician or physical therapist if this is appropriate 8: INJURY STATEMENT I understand that in unlikely event of injury to me resulting directly from my participation in this study, if such injury were reported promptly, then medical treatment will be available to me, but no further compensation would be provided. I understand that by my agreement to participate in this study I am not waiving any of my legal rights.
I have explained to ___________________________(Name of subject) the purpose of the research, the procedure required and the possible risk and benefits to the best of my ability.
ANNEXURE-II
CONSENT FORM
I confirm that ________Dr Muddaser Mujawar________________________ has explained to me the purpose of research, the study procedure that I will undergo, and the possible risk and discomforts as well as benefits that I may experience.
Alternative to my participation in the study, I have also been to give my consent form. Therefore, I agree to give consent to participate as a subject and this research project.
Participant
Date:
Signature of witness
Date:
Modified from Portney L.G. Watkins M.P., in Foundation of Clinical Research, Second Edition, New Jersey, Prentice Hall Health 2000. (A
B.L.D.E.US Shri B.M.Patil Medical College, Bijapur Department of Physiology CLINICAL PROFORMA Title : A STUDY OF DISTRIBUTION OF ABO BLOOD GROUPS
Name:
Age:
Sex:
Temperature:
Cardiovascular system:
Respiratory system:
Per abdomen:
PARAMETERS FOR STUDY: 1. Blood Sugar Level 2. Fasting 3. Post-Prandial 4. Random 5. Blood Group(ABO & Rh) 6. Secretor status
Signature of PG student
BIODATA OF GUIDE: 1. Name 2. Designation 3. Date of Birth 4. Qualificatio : Dr. Manjunatha Aithala. : Professor and Head Dept of Physiology. : 26/06/1964. : M.B.B.S [Jan1993, Mahadevappa Rampure Medical College, Gulbarga. M.D [SEP 2001, B.L.D.E.US Shri B.M.Patil Medical college Bijapur] 5. KMC Registration no 6. College address : 38820 : Department of Physiology B.L.D.E.US Shri B.M.Patil Medical College, Bijapur 586103
7. Teaching Experience
8. Contact no
1. Name 2. Qualification
: Dr. Muddaser Mujawar : B.H.M.S [ 2010, A.M.SHAIKH HOMOEOPATHIC MEDICAL COLLEGE, BELGAUM ]
3. Registration No
: A. 10850
4.Address for Correspondence : Department of Physiology. B.L.D.E.U Shri 5. Mobile no. .B.M.Patil Medical college Bijapur. 586103
: 9590713327