dr.muddassir final synopsis.. - copy - copy (2)

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B.L.D.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

B.L.D.E.U’S SHRI B.M.PATIL MEDICAL COLLEGE

BIJAPUR-586103



B.L.D.E.UNIVERSITY

SHRI B.M.PATIL MEDICAL COLLEGE BIJAPUR

1. NAME OF THE CANDIDATE AND

ADDRESS

DR.MUDDASER MUJAWAR

DEPARTMENT OF PHYSIOLOGY

B.L.D.E.U’S SHRI B.M.PATIL MEDICAL

COLLEGE HOSPITAL AND RESEARCH

CENTRE,

BIJAPUR-586103

2. NAME OF THE INSTITUTE B.L.D.E.U’S SHRI B.M.PATIL MEDICAL

COLLEGE HOSPITAL AND RESEARCHCENTRE,

BIJAPUR-586103

3. COURSE OF THE STUDY AND

SUBJECT

3 YEARS, MSc MEDICAL PHYSIOLOGY

4. DATE OF ADMISSION TO THE

COURSE.

02-08-2011

6. TITLE OF THE TOPIC“A STUDY OF DISTRIBUTION

OFABO 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

ANNEXURE-I

ANNEXURE-I

ANNEXURE-I

MATERIALS AND METHODS

7.1 SOURCE OF DATA ANNEXURE-II



11

.

NAME AND DESIGNATION

11.1 GUIDE

11.2 SIGNATURE

11.3 HEAD OF THE DEPARTMENT

11.4 SIGNATURE

DR. MANJUNATHA. AITHALA.

M.D.PHYSIOLOGY

PROFESSOR AND HEAD


DR. MANJUNATHA. AITHALA.

M.D.(MEDICAL PHYSIOLOGY)

PROFESSOR AND HEAD


12

.

12.1 REMARKS OF THE CHAIRMAN

AND PRINCIPAL

12.2 SIGNATURE



ANNEXURE – I

6. Brief resume of the intended work

NEED FOR THE STUDY

Interest in the presence of and importance of blood groups had aroused during second halfof 19th century because of conclusive association of blood groups and its roles inpathogenesis of erythroblastosis foetalis. So far, more than 20 genetic polymorphism havebeen shown to be there in the antigens of the red cells and serum proteins. Theagglutinogens in each system are determined by allelic genes occurring at specific loci onthe chromosomes.1

Moreover, each system of antigens inherited independently of other system. Thedifferent frequency of occurrence in different racial groups, importance of is sensitization,the simple mode of inheritance to serve as genetic markers and the biochemical properties

etc ; all made the study of blood groups as an integral part of serology, anthropology,genetics and as well as biochemistry. 2

ABO blood groups have been co-related with various diseases. Incidence of peptic

ulcer is much higher in blood group “O”, where as cancer of stomach, tumors of

salivary glands, and leprosy are more frequent in “A” group individual. It is

assumed that blood group substances may interact with microbes and makes a

person more or less susceptible to a particular disease. Moreover, progressive less

of blood group substances from the tissues cell make them carcinomatious. 3

Further, co-relation between secretor status and diseases of

gastrointestinal tract has also been worked out. These blood group substances arealso present on leucocytes and seem to affect their property of phagocytosis. 3

Absence of blood group substances in body fluids is a health disadvantage, as this

appears to increase susceptibility to number of diseases. The secretion of the

antigen into saliva and mucous offers added degree of prediction against bacterial

fimbria letins. 4

Earlier studies have indicated that secretor status are more prone to hemolytic

anemia, oral cancer and viral infections , where as diseases like tuberculosis,

Rheumatic fever, juvenile diabetes and various auto immune diseases are more

common in non-secretors. 5



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 the study has been

undertaken.



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

“ e” 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

6.3 Objectives Of the study

To study distribution of blood groups among patients with diabetes mellitus &

secretor status compared to healthy individuals of both sexes of BLDE’S SHRI

B.M.PATIL MEDICAL COLLEGE AND HOSPITAL in Bijapur.



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 BLDEU’s 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 BLDEU’s

SHRI B. M. Patil Medical College and Hospital in Bijapur, will be selected for the

control group.

Duration of study: From Feb 2013 to Jan 2014.



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 α /2 × σ }2

E

Where zα/2 = Value of Z at α/2 % level of significance

σ = Standard Deviation

E = Permissible error

1)Determination of Diabetic status: The diabetic status of each patient will be

determined by using the criteria of National Diabetes Data Group of National

Institute of Health. The criteria is as follows.

Symptoms of diabetes plus random blood glucose conc. > 11.1 mmol/L (200mg/dl)

OR

Fasting plasma glucose > 7.0 mmol/L (126mg/dl)

OR

Two-hour plasma glucose > 11.1 mmol/L (200mg/dl) during an glucose tolerance

test.

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: The following subjects will be excluded from the study:

1. Subjects with malignancies like leukemia which leads to weakning or

loss of blood group antigens on cell.2. Subjects associated with gram negative septicaemia, intestinal

obstruction and carcinoma of colon or rectum which leads to acquired

“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 thelevel of the nipple with minimum clothing with the help of standard tailor

tape nearest to 0.1centimetre.

4. Body Mass Index (kilogram/meter 2): 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

Title of the project: “A STUDY IF DISTRIBUTION OF ABO

BLOOD GROUPS AMONG PATIENTS WITH DIABETES

MELLITUS AND THEIR SECRETOR STATUS”

P rincipal investigator/ P.G.Guide’s name: DR. MANJUNATHA AITHALA MD



PROF AND HEAD


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

investigator ’s 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.U’S Shri B.M.Patil Medical College, Bijapur

Department of Physiology

CLINICAL PROFORMA

Title : “A STUDY OF DISTRIBUTION OF ABO BLOOD GROUPS

AMONG PATIENTS WITH DIABETES MELLITUS AND THEIR

SECRETOR STATUS”

Name : Age: Sex:

Address & phone no:



General physical examination

PR: BP: Wt: Ht:

Temperature: RR:

Systemic Examination:

Cardiovascular system:

Respiratory system:

Central nervous 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 Signature of Guide and HOD



BIODATA OF GUIDE:

1. Name : Dr. Manjunatha Aithala.

2. Designation : Professor and Head Dept of Physiology.

3. Date of Birth : 26/06/1964.

4. Qualificatio : M.B.B.S [Jan1993, Mahadevappa Rampure Medical

College, Gulbarga.

M.D [SEP 2001, B.L.D.E.U’S Shri B.M.Patil Medical

college Bijapur]

5. KMC Registration no : 38820

6. College address : Department of Physiology

B.L.D.E.U’S Shri B.M.Patil Medical College, Bijapur -

586103



7. Teaching Experience : UG Teaching since 1994.

: PG Teaching since 2007.

8. Contact no : 9902103620.

INVESTIGATOR ’S BIO-DATA

1. Name : Dr. Muddaser Mujawar

2. Qualification : 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 .B.M.Patil Medical college Bijapur. – 586103

5. Mobile no. : 9590713327

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