"STUDY OF CAROTID INTIMA MEDIA THICKNESS IN DIABETIC & NON DIABETIC SUBJECTS; A STUDY FROM SOUTH INDIAN RURAL HOSPITAL"
SYNOPSIS OF DISSERTATION SUBMITTED TO
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
In partial fulfillment of regulations for the award of
M.D. Degree in General Medicine
Submitted by
Dr. SHIVARANJAN K.P M.B.B.S.
POST GRADUATE STUDENT IN
GENERAL MEDICINE (M.D.)
Under the guidance of
Dr. VIMALA IYENGAR. M.B.B.S., M.D.,
ASSOCIATE PROFESSOR
DEPARTMENT OF GENERAL MEDICINE,
A.I.M.S., B.G.NAGARA-571448.
DEPARTMENT OF GENERAL MEDICINE
ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES,
B.G.NAGARA-571448
2012
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / NAME OF THE CANDIDATEAND ADDRESS
(in block letters) / Dr. SHIVARANJAN K.P
P.G. IN GENERAL MEDICINE,
A.I.M.S., B.G. NAGARA,
MANDYA DISTRICT –571448
2. / NAME OF THE INSTITUTION /
ADICHUNCHANAGIRI INSTITUTE OF
MEDICAL SCIENCES, B.G.NAGARA.3. / COURSE OF STUDY AND SUBJECT /
M.D. IN GENERAL MEDICINE
4. / DATE OF ADMISSION TO COURSE / 4th JUNE 20125. / TITLE OF THE TOPIC / "STUDY OF CAROTID INTIMA MEDIA THICKNESS IN DIABETIC & NON DIABETIC SUBJECTS; A STUDY FROM SOUTH INDIAN RURAL HOSPITAL"
6. / BRIEF RESUME OF INTENDED WORK
6.1 NEED FOR THE STUDY
6.2 REVIEW OF LITERATURE
6.3 OBJECTIVES OF THE STUDYs / APPENDIX-I
APPENDIX-IA
APPENDIX-IB
APPENDIX-IC
7 / MATERIALS AND METHODS
7.1 SOURCE OF DATA
7.2 METHOD OF COLLECTION OF DATA : (INCLUDING SAMPLING PROCEDURE IF ANY)
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER ANIMALS, IF SO PLEASE DESCRIBE BRIEFLY.
7.4 HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3 / APPENDIX-II
APPENDIX-IIA
APPENDIX-IIB
YES
APPENDIX-IIC
YES
APPENDIX-IID8. / LIST OF REFERENCES /
APPENDIX - III
9. / SIGNATURE OF THE CANDIDATE /10. /
REMARKS OF THE GUIDE
/ As we know diabetes is a major health concern in India and world over. New tools of risk assessment are taking centre stage in risk stratification so as to avoid morbidity and mortality which is mainly due to atherosclerosis. Hence the assessment of carotid intima media thickness is one of the investigation to assess the early changes of vascular complications like atherosclerosis before patient become symptomatic.11. / 11.1 NAME OF THE GUIDE / Dr. VIMALA IYENGAR M.B.B.S, M.D.
ASSOCIATE PROFESSOR,
DEPARTMENT OF GENERAL MEDICINE,
A.I.M.S, B.G.NAGARA.
11.2 SIGNATURE OF THE GUIDE
11.3 CO-GUIDE (IF ANY) / -
11.4 SIGNATURE / -
11.5 HEAD OF DEPARTMENT / Dr. VASUDEVA NAIK. H. M.B.B.S, M.D.
PROFESSOR AND HEAD,
DEPARTMENT OF GENERAL MEDICINE,
A.I.M.S, B.G.NAGARA.
11.6 SIGNATURE
12 / 12.1 REMARKS OF THE CHAIRMAN
AND PRINCIPAL / The facilities required for the investigation will be made available by the college
Dr. M.G. SHIVARAMU, M.B.B.S, M.D.
PRINCIPAL,
AIMS, B.G. NAGARA.
12.2 SIGNATURE
APPENDIX-I
6.BRIEF RESUME OF THE INTENDED WORK
APPENDIX –I A
6.1 NEED FOR THE STUDY
Patients with diabetes mellitus suffer unduly from premature and severe atherosclerosis. The Framingham study pointed out that diabetic individuals have higher concentration of serum lipids, hypertension, obesity and thus are more prone to advanced atherosclerosis and its sequelae i.e, coronary artery disease.
Diabetic as a metabolic disorder is rising at an alarming rate all over the world and has been a reason for concern due to the complications associated with it. With India having the highest number of diabetic patients in the world, the diabetes is posing an enormous health problem in the country. Calling India the diabetes capital of the world the international journal of diabetes in developing countries says that there is alarming rise in prevalence.
Hyperglycemia, hypertension, LDL cholesterol and obesity are widely accepted as risk factors for coronary artery disease which are associated with premature atherosclerosis.
Atherosclerosis is an inflammatory disease that often begins in childhood and slowly progresses through a long asymptomatic phase. Since atherosclerosis is a generalized phenomenon and is more or less present equally in coronary, cerebral and carotid arteries; ultrasonographic assessment of easily accessible arteries such as carotid arteries have been advocated as a surrogate marker over less accessible vessels such as coronary and cerebral arterial systems. High resolution B mode ultrasound is a non invasive technique widely used to assess atherosclerosis in superficial arteries like carotid arteries. It allows accurate measurement of distance between blood-intima and media-adventitia interfaces of carotid wall, which is defined as carotid intima media thickness. Ultrasound imaging of carotid vessels can provide information on Carotid Intima Medial Thickness (CIMT), plaque presence and type, calcification, and wall diameter, offers the ability to examine pre- symptomatic lesions, assess atherosclerotic burden and hence the risk of cardiovascular events. Such non-invasive screening procedures are valuable in identifying diabetic patients at risk for CAD. In clinical settings, this can potentially lead to early intervention.
Intima-media thickness of the common carotid artery was recommend as a useful parameter to assess the presence of coronary artery disease in a publication of the American Heart Association. Lesions found on coronary arteriography correlate with the presence of lesions in the carotid arteries.10
IMT measurement should be included as a diagnostic tool, given the paucity of facilities for invasive techniques in India. This will help in early identification of clinical and premature Coronary Artery Disease. Finally, long-term follow-up studies from India are required to address the utility of this technique for therapeutic intervention.
APPENDIX –I B
6.2 REVIEW OF LITERATURE
Asian Indians are known to have very high rates of diabetes1,2 and premature coronary artery disease3.
Diabetes leads to both micro and macro vascular complications. For assessment of macro vascular complications, carotid intima media thickness (CIMT), is a well standardized surrogate marker for assessing cardiovascular risk, and it is well accepted as a parameter of subclinical atherosclerosis. CIMT is a strong predictor of future cardiovascular event and is associated with conventional markers of cardiovascular risk such as age hypertension and dyslipidemia4
Earlier studies have documented significant role of CIMT in cardiovascular disease prediction in both non diabetic and diabetic population5
Studies have shown that in Asian Indians there is an association between increased CIMT and type2 diabetes, CIMT significantly higher in diabetic patients than in non diabetic subjects6,7 and also demonstrated that subclinical atherosclerosis increases with increasing degrees of glucose intolerance8
Carotid intima media thickness is a simple and inexpensive tool to assesses the cumulative effect of atherosclerotic risk factors and is an independent predictor of future cardiovascular risk. Carotid intima media thickness correlates with cardiac risk factors and is an independent predictor of future myocardial infarction. Tests for subclinical atherosclerosis such as CIMT, will help clinicians to more effectively identify the vulnerable patients who would benefit from aggressive prevention intervention9
Bonora Enzo, Tessari Roberto, Micciolo Rocco et al (1997) studied carotid IMT in non-diabetic and NIDDM patients and concluded that diabetes is characterized by a greater thickness of carotid artery
De Groot Eric, Van Leuven Sander I, Duivenvoorden Raphael et al (2008) studied different imaging modalities to assess atherosclerosis and described the application of carotid intima media thickness measurements as a tool in risk evaluation of individuals and in studies of atherosclerosis progression and regression.
Anath Oren, Lydia E Vos, Cuno S P M Uiterwal et al (2003) evaluated 750 healthy young adults and concluded that an unfavorable cardio vascular risk profile is associated with a marked increase in common carotid intima media thickness in young adulthood.
Rajala U, Paivansalo M, Laakso M et al (2003) evaluated the associations of ultrasonographic manifestations of carotid atherosclerosis with systolic and diastolic blood pressure and pulse pressure in 65 year old finnish population and concluded that high systolic blood pressure was associated with severe carotid intima media thickness.
APPENDIX –IC
AIMS AND OBJECTIVES
Ø To identify all admissions with diabetes mellitus.
Ø To measure carotid intima media thickness in subjects with and without diabetes mellitus.
APPENDIX-II
7.0 MATERIALS AND METHODS
APPENDIX-IIA
7.1 SOURCE OF DATA:
This is a prospective observational study of 50 diabetic patients including both in- patients and out- patients. Carotid intima media thickness is assessed on all this patients and compared with 50 subjects who are non diabetic for a period of 2 years from November 2012 to November 2014.
STUDY DESIGN : A Comparative Study
STUDY PERIOD : 24 months
APPENDIX-IIB
7.2 METHOD OF COLLECTION OF DATA
SAMPLE SIZE : TOTAL 100
CASE : 50 Subjects
CONTROL : 50 Subjects
INCLUSION CRITERIA
Ø Patients aged more than 30 years with diabetes mellitus
Ø Includes both males and female
EXCLUSION CRITERIA:
Ø Patients with ischaemic heart disease (acute coronary syndrome, stable angina, prior history of coronary artery bypass graft, per cutaneous coronary angioplasty)
Ø Patients with congestive heart failure
Ø Patients with renal disease
Ø Patients with stroke
Ø Patients with peripheral vascular disease
APPENDIX-II C
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so describe briefly?
YES, it requires the following investigations to be conducted on patients included in the study.
INVESTIGATIONS :
Routine investigations:
· Hemoglobin percentage
· Total WBC count
· Differential WBC count
· Erythrocyte sedimentation rate
· Platelet count
· Bleeding time
· Clotting time
· Random blood sugar
· Fasting Blood Sugar
· Post Prandial Blood Sugar
· Blood urea
· Serum creatinine
· Total cholesterol
· LDL cholesterol
· Serum Triglycerides
· ECG
· HbA1c
Specific investigations:
· High resolution B mode ultrasonography system
APPENDIX-IID
PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL
SECTION A
A / Title of the study / "STUDY OF CAROTID INTIMA MEDIA THICKNESS IN DIABETIC & NON DIABETIC SUBJECTS; A STUDY FROM SOUTH INDIAN RURAL HOSPITAL"B / Principle investigator
(Name and Designation) / Dr. SHIVARANJAN K.P
P.G. IN GENERAL MEDICINE,
A.I.M.S., B.G. NAGARA,
MANDYA DISTRICT –571448
C / Co-investigator
(Name and Designation) / Dr. VIMALA IYENGAR M.B.B.S, M.D.
ASSOCIATE PROFESSOR,
DEPARTMENT OF GENERAL MEDICINE,
A.I.M.S, B.G.NAGARA.
D / Name of the Collaborating
Department/Institutions / Department of General Medicine,
AIMS, B.G. Nagara
E / Whether permission has been obtained from the heads of the collaborating departments & Institution / NASection – B
Summary of the Project / APPENDIX I
Section – C
Objectives of the study / APPENDIX ICSection – D
Methodology / APPENDIX IIBA / Where the proposed study will be undertaken / ADICHUNCHANAGIRI HOSPITAL AND RESEARCH CENTRE, B.G.NAGARA
B / Duration of the Project /
24 MONTHS
C / Nature of the subjects:Does the study involve adult patients?
Does the study involve Children?
Does the study involve normal volunteers?
Does the study involve Psychiatric patients?
Does the study involve pregnant women? / YES
NO
YES
NO
NO
D / If the study involves health volunteers
I. Will they be institute students?
II. Will they be institute employees?
III. Will they be Paid?
IV. If they are to be paid, how much per session? / YES
YES
NO
NO
E / Is the study a part of multi central trial? / NO
F / If yes, who is the coordinator?
(Name and Designation)
Has the trial been approved by the ethics Committee of the other centers?
If the study involves the use of drugs please indicate whether.
I. The drug is marketed in India for the indication in which it will be used in the study.
II. The drug is marketed in India but not for the indication in which it will be used in the study
III. The drug is only used for experimental use in humans.
IV. Clearance of the drugs controller of India has been obtained for:
Use of the drug in healthy volunteers
Use of the drug in-patients for a new indication.
Phase one and two clinical trials
Experimental use in-patients and healthy volunteers. / NA
NA
NA
NA
NA
NA
NA
NA
G / How do you propose to obtain the drug to be used in the study?
- Gift from a drug company
- Hospital supplies
- Patients will be asked to purchase
- Other sources (Explain) / NA
H / Funding (If any) for the project please state
- None
- Amount
- Source
- To whom payable / NA
I / Does any agency have a vested interest in the out come of the Project? / NO
J / Will data relating to subjects /controls be stored in a computer? / NO
K / Will the data analysis be done by
- The researcher?
- The funding agent / YES
NO
L / Will technical / nursing help be required form the staff of hospital.
If yes, will it interfere with their duties?
Will you recruit other staff for the duration of the study?
If Yes give details of
I. Designation
II. Qualification
III. Number
IV. Duration of Employment / NO
NO
NO
NA
NA
NA
NA
NA
M / Will informed consent be taken? If yes
Will it be written informed consent:
Will it be oral consent? Will it be taken from the subject themselves?
Will it be from the legal guardian? If no, give reason: / NO
NA
NA
NA
NA
N / Describe design, Methodology and techniques / APPENDIX II
Ethical clearance has been accorded.
Chairman,
P.G Training Cum-Research Institute,
A.I.M.S., B.G.Nagara.
Date :
PS : NA – Not Applicable
APPENDIX - III
LIST OF REFERENCES:
1. International Diabetes Federation, Diabetes Atlas. Unwin N, Whiting D, Guariguata L, Ghyoot G, Gan D(eds). Fifth Edition, International Diabetes Federation, Brussels, Belgium, 2011; 11-74.
2. Anjana RM, Pradeepa R, Deepa M, Datta M, Sudha V, Unnikrishnan R, et al. Prevalance of diabetes and prediabetes (impaired fasting glucose or/and impaired glucose tolerance) in rural and urban India; Phase 1 results of the Indian Council of Medical Research-India Diabetes (INDIAB) study. Diabetologin 2011; 54: 3022-3027.
3. Reddy KS, Yusuf S. Emerging epidemic of cardiovascular disease in developing countries. Circulation 1998; 97: 596-601.
4. Mannami T, Konishi M, Baba S, Nishi N, Terao A. Prevalance of asymptomatic carotid atherosclerotic lesions detected by high-resolution ultrasonography and its relation to cardiovascular risk factors in the general population of a Japanese city: the Suita study. Stroke 1997; 28: 518-525.