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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.US SHRI B.M.PATIL MEDICAL COLLEGE

BIJAPUR-586103


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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.US SHRI B.M.PATIL

MEDICAL COLLEGE HOSPITAL AND

RESEARCH CENTRE,

BIJAPUR-586103

2. NAME OF THE INSTITUTE B.L.D.E.US SHRI B.M.PATIL

MEDICAL COLLEGE HOSPITAL AND

RESEARCH CENTRE,

BIJAPUR-586103

3. COURSE OF THE STUDY AND

SUBJECT

3 YEARS, MSc MEDICAL

PHYSIOLOGY

4. DATE OF ADMISSION TO THE

COURSE.

02-08-2011


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6. TITLE OF THE TOPIC 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

ANNEXURE-I

ANNEXURE-I

ANNEXURE-I

MATERIALS AND METHODS

7.1 SOURCE OF DATA

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.

ANNEXURE-II

ANNEXURE-II

ANNEXURE-II

ANNEXURE-II


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7.4 HAS ETHICAL CLEARANCE

BEEN OBTAINED FROM

YOUR INSTITUTION IN CASE

OF 7.3

8. LIST OF REFERENCES ANNEXURE-III

9. SIGNATURE OF THE

CANDIDATE

1

0.

REMARKS OF THE GUIDE

1

1.

NAME AND DESIGNATION

11.1 GUIDE

11.2 SIGNATURE

11.3 HEAD OF THE

DEPARTMENT

DR. MANJUNATHA. AITHALA.

M.D.PHYSIOLOGY

PROFESSOR AND HEAD


DR. MANJUNATHA. AITHALA.

M.D.(MEDICAL PHYSIOLOGY)

PROFESSOR AND HEAD



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11.4 SIGNATURE

1

2.

12.1 REMARKS OF THE

CHAIRMAN AND PRINCIPAL

12.2 SIGNATURE


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ANNEXUREI

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 half of 19thcentury because of

conclusive association of blood groups and its roles in

pathogenesis of erythroblastosis foetalis. So far, more than 20

genetic polymorphism have been shown to be there in the

antigens of the red cells and serum proteins. The

agglutinogens in each system are determined by allelic genesoccurring at specific loci on the chromosomes.1

Moreover, each system of antigens inherited

independently of other system. The different 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 are also present on leucocytes

and seem to affect their property of phagocytosis. 3


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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 anA 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


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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.


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ANNEXUREI

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 asignificantly 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


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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 thatP falciparumwas 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;910

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 malesubjects 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


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A study was conducted in Non-O blood groups subjects anddemonstrated 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 severemalaria 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.


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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.


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ANNEXUREI

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 BLDES SHRI B.M.PATIL MEDICAL

COLLEGE AND HOSPITAL in Bijapur.


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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.

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.


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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

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 anglucose tolerance test.


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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 septicemia,

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


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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 withsubject standing without their footwears nearest to 0.1

centimetres.

2. Weight (in kilograms): The subjects will be weighed instandardized machine with minimum clothing nearest to

0.1 kilogram.

3. Chest circumference: It will be measured at deepinspiration position at the level of the nipple with

minimum clothing with the help of standard tailor 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.


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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

Haemagglutination 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.


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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.


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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

Principal investigator/ P.G.Guidesname:

DR.MANJUNATHAAITHALAMD

PROF AND HEAD



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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 statusand Diabetes mellitusin patients andnormal 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.


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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


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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.


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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:


25/31

Modified from Portney L.G. Watkins M.P., in Foundation of

Clinical Research, Second Edition, New Jersey, Prentice Hall

Health 2000. (A

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:


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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


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Signature of PG student Signature of Guide & 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. Qualification : 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 : 38820

6. College address : Department of Physiology

B.L.D.E.US Shri B.M.Patil Medical

College, Bijapur - 586103

7. Teaching Experience : UG Teaching since 1994.

: PG Teaching since 2007.


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8. Contact no : 9902103620.

INVESTIGATORSBIO-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. : 9886003203


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LIST OF REFERENCES

1. L. Qi, M. C. Cornelis, P. Kraft et al., Genetic variants in ABO

blood group region, plasma soluble E-selectin levels and risk of

type 2 diabetes,Human Molecular Genetics, vol. 19, no. 9, ArticleID ddq057, pp. 18561862, 2010.

2. El Hajj, J. G. Hashash, E. M. K. Baz, H. Abdul-Baki, and A. I. Sharara,

ABO blood group and gastric cancerSouthern Medical Journal, vol.

100, no. 7, pp. 726727, 2007.

3. The relationship between blood groups and disease(David. J.

Anstee.)

4. Variant ABO Blood Group Alleles, Secretor Status and Risk of

Pancreatic Cancer: Results from the Pancreatic Cancer CohortConsortium(Brian M. Wolpin, Peter Kraft, Mousheng Xu, Emily

Steplowski.)

5. Biological and clinical aspects of ABO blood group system. J.

Med. Invest. 2008;55:174- 182. Hosoi E.

6. Advanced Topics in Blood Type Diet.Secretors and Non-secretors.(Dr. D'Adamo )

7.Association of ABO blood groups with diabetes mellitusMuhammad Kamil*,Hamid Ali Nagi Al-Jamal andNarazah Mohd Yusoff, Citation: Libyan J Med 2010, 5: 4847 - DOI:10.3402/ljm.v5i0.4847Libyan J Med 2010. 2010 Muhammad Kamil et al.

8. Ayub Med Coll Abbottabad.

Frequency of ABO and Rhesus blood groups in District Swat,

Pakistan \ Khattak ID,Khan TM,Khan P,Shah SM,Khattak ST,Ali

A.2008 Oct-Dec;20(4):127-9.
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19. Risch HA, Yu H, Lu L, Kidd MS. ABO blood group, Helicobacterpylori seropositivity, and risk of pancreatic cancer: a case-controlstudy. J Natl Cancer Inst. 2010;102:5025.

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