Download diastolic dysfunction in normotensive type2 dm

RAJIV GANDHI UNIVERSITY OF HEALTH
SCIENCES,
BANGALORE, KARNATAKA.
SYNOPSIS FOR REGISTRATION OF
SUBJECT FOR DISSERTATION
TITLE OF THE TOPIC
“DIASTOLIC DYSFUNCTION IN NORMOTENSIVE
TYPE2 DM”
DR.SAYYED ASEF MAULANA
PG GENERAL MEDICINE,
AL-AMEEN MEDICAL COLLEGE,
BIJAPUR
1
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA.
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
01
Name of the candidate and Address (in
block letters)
DR. SAYYED ASEF MAULANA
PG GENERAL MEDICINE
DEPT. OF MEDICINE
AL-AMEEN MEDICAL COLLEGE,
BIJAPUR.
02
Name of the Institution
AL-AMEEN
BIJAPUR
03
Course of study and Subject
M.D GENERAL MEDICINE
04
05
Date of admission to course
Title of the topic
MAY 2011
“DIASTOLIC DYSFUNCTION IN
NORMOTENSIVE TYPE 2 DM”
06
Brief resume of the intended work
6.1 Need for the study
6.2 Review of literature
6.3 Objectives of the Study
Material and Methods
Vide Annexure – I
Vide Annexure – II
Vide Annexure – III
7.1 Source of Data
Vide Annexure – IV
7.2 Method of collection of data
(including sampling procedure, if
any )
Vide Annexure – V
7.3 Does the Study require any
investigations or interventions to be
conducted on patients or other
humans or animals? If so, please
describe briefly.
Vide Annexure – VI
7.4 Has ethical Clearance been
obtained from your institution in
case of 7.3
Yes
(Certificate has been enclosed herewith )
07
08
7.5 Sample informed consent form
List of References
MEDICAL
Vide Annexure – VII
2
COLLEGE,
09
Signature of the Candidate
10
Remarks of the Guide
This study will help in the better
understanding of left ventricular functional
and
structural
abnormalities
in
normotensive patients with type 2 DM
11
Name and Designation of
11.1 Guide
DR.VITHAL RAO
MD.GENERAL MEDICINE
PROFESSOR
DEPARTMENT OF MEDICINE
AL-AMEEN MEDICAL COLLEGE,
BIJAPUR
11.2 Signature
11.3 Co-Guide
DR. N. S. BIRADAR
MD.GENERAL MEDICINE
ASSO. PROFESSOR
DEPARTMENT OF MEDICINE
AL-AMEEN MEDICAL COLLEGE,
BIJAPUR
11.4 Signature
11.5 Head of the Department
DR. BILAL BIN ABDULLAH
MD GENERAL MEDICINE
PROFESSOR AND H.O.D.
DEPARTMENT OF MEDICINE
AL-AMEEN MEDICAL COLLEGE,
BIJAPUR
11.6 Signature
12
Name of Dean
DR. B. S. PATIL
12.1 Remarks of Dean and Chairman
We will provide the necessary facilities for
the study
12.2 Signature
3
ANNEXURE – I
BRIEF RESUME OF THE INTENDED WORK
6.1 NEED FOR THE STUDY
The world today is witnessing an epidemic of diabetes mellitus. Globally and
nationally, diabetes and its complications has become the most important
contemporary and challenging health problem.It is estimated that there will be more
than 200 million diabetics in the world within the next 10 years. India has already
become the diabetes capital of the world with over 30 million affected patients that is
alarmingly just a tip of the iceberg and is expected to touch the 55 million mark in
2025.1
The impact of diabetes on both the health of the individual and the health care system
resides almost entirely in the long term complications of diabetes.
The FRAMINGHAM HEART STUDY revealed marked increase in peripheral
arterial disease, congestive heart failure, coronary artery disease, myocardial
infarction and sudden death(The risk increases from 1 to 5fold) in diabetics.2
The American Heart Association recently designated DM as a major risk factor for
cardiovascular disease along with other major risk factors (smoking, hypertension and
hyperlipidemia).3
Though DM is associated with a multitude of cardiovascular complications recent
studies
have
suggested
structural
myocardial
involvement
termed
“DM
Cardiomyopathy”.4 Myocardial involvement in diabetes may occur relatively early in
the course of the disease, initially impairing the diastolic relaxation and when more
extensive resulting in decreased myocardial contraction. Prior to the development of
4
symptomatic CHF sub-clinical LV dysfunction (systolic and diastolic) does exist for
some time.5
Further, increased LV mass has been documented in Type 2 Diabetes even in
normotensive individuals at an early stage. LVH is an ominous prognostic sign and
independent risk factor for further cardiac events andhence identification of this
subset of patients would enable early interventional strategies that could decrease the
incidence of cardiac events.
There have been few studies that have evaluated the development of systolic and
diastolic LV dysfunction and LV mass in Type 2DM patients, who are normotensive
and have no cardiac symptoms.6
The present study was undertaken to make further inroads into this aspect of diabetes
that would have far flung implications in management of diabetes as a whole.
5
ANNEXURE – II
6.2 REVIEW OF LITERATURE
DIABETES MELLITUS is defined as a syndrome characterized by chronic
hyperglycemia, associated with disturbances of carbohydrate, fat and protein
metabolism due to absolute or relative deficiency in insulin secretionand/or action.
In view of the wide heterogeneity, Diabetes is regarded as a “syndrome” rather than a
disease entity.
Abnormalities of LV systolic function:
This is usually identified on echocardiographic measurement of Ejection Fraction.
EF<55% denotes LV dysfunction.
Abnormalities of LV diastolic function:7
1. Diastolic abnormalities:
Characterized by abnormal filling indices, they are commonly identifiedon echo by
prolonged IVRT; however, these patients have no clinical symptoms. In this situation
the ventricle is able to compensate for abnormal diastolic function and to maintain a
normal level of left ventricular filling pressure.
2. Diastolic dysfunction:
Characterized by increased diastolic filling pressure which may be responsible for the
occurrence of dyspnoea especially during exercise.
3. Diastolic heart failure:
Associated with clinical signs like PND and orthopnoea.
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DIABETES AND CARDIOVASCULAR DISEASE
Diabetes mellitus is an independent risk factor for cardiovascular disease(CVD). In
the FRAMINGHAM STUDY the risk of CVD for diabetic subjects at baseline was
twofold higher in men and three to four fold for women after adjustment for other risk
factors such as dyslipidemia and hypertension. More recently NHANES1 study also
showed that the diabetic population was twice as likely to develop CAD as the non
diabetic population with excess mortality.
The MRFIT STUDY shows that men with diabetes had an absolute riskof death due
to CAD more than three times than the nondiabetic cohort. In the six nation OASIS
study, diabetic patients presenting with unstable angina or Non Q MI had increased
rate of stroke, CHF and death during index hospitalization compared with the nondiabetic group.
In the Finnish contribution to WHO MONICA (World Health Organization
Multinational Monitoring of Trends and Determinants of Cardiovascular Disease)
project, the 1 year mortality was 38% higher for diabetic men and 86% higher for
women.In view of the above, studies have been undertaken in recent times to identify
structural and functional abnormalities in normotensive diabetics who have no cardiac
symptoms. Most of the recent studies identified changes in LV mass and LV systolic
and diastolic function indices even before the patients are symptomatic.
7
The main factors that contribute to the increased incidence of
cardiovascular disease in DM are:
1. The acceleration of atherosclerotic process leading to macro vascular disease.
2. Development of specific cardiomyopathy
3. Progressive micro vascular disease
4. Development of autonomic neuropathy
Noninvasive methods have confirmed that fibrosis is a key feature of the heart of
diabetic patients without evident cardiac disease. Increased level of collagen in
diabetics has been associated with changes in left ventricular diastolic function.
Chronic hyperglycemia leads to the formation of AGE’s that modify the extracellular
matrix, resulting in elasticity of the vessel wall and could interfere with myocardial
function as well. These coupled with abnormal myocardial calcium handling result in
poor elastic recoil, leading to impairment in early rapid diastolic filling(E) manifest
by prolonged Intraventricular isovolumetric relaxation time and Deceleration time,
and increased Mitral (A) velocity.
In the setting of insulin resistance, there is release of free fatty acids from adipose
tissue into the plasma. FFA becomes the dominant fuel for myocardial energy in the
form of free fatty acid oxidation within cardiac myocytes. In addition, the rise in
plasma free fatty acids leads to a decrease in glycolysis and glucose oxidation in these
cells. Free fatty acid oxidation is a less efficient means of generating adenosine
triphosphate than glucose oxidation thus contributing to chronic left ventricular
dysfunction.
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ANNEXURE – III
1.3 OBJECTIVES OF THE STUDY
1) Echocardiographic assessment of left ventricular functional and structural
abnormalities in Type 2 DM patients who are normotensive and without any
cardiac symptoms.
2) To assess the relationship between the duration of diabetes mellitus and the
development of LV structural and functional abnormalities
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ANNEXURE – IV
MATERIAL AND METHODS
7.1 SOURCE OF DATA
Population: This study will be conducted on 100 Type II normotensive diabetes
mellitus patients attending the Department of Internal Medicineat Al Ameen Medical
College Hospital, Bijapur and District hospital, Bijapur and compared to the control
group (100 patients)
.
Period of the study: DEC 2011-MAY 2013.
DESIGN OF STUDY: Case control cross sectional study.
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ANNEXURE – V
7.2 METHOD OF COLLECTION OF DATA
INCLUSION CRITERIA:
1) All cases of Type 2DM diagnosed by WHO criteria
2) Age: 40-60 years
3) BP: <130/86 (at least 3 recordings with the highest recording taken into
consideration)
EXCLUSION CRITERIA:
Patients with
1) Systemic Hypertension(BP>140/90)
2) Ischemic heart disease(abnormal E.C.G. and RWMA onEcho)
3) CHF
4) Congenital or Acquired Valvular Heart Disease
5) CRF
6) Age>60yrs
7) Cardiac signs and symptoms, exertional dysnoea, chest pain.
8) Palpitation raised JVP.
9) PDR/NPDR and
10) Microalbuminuria.
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The study group was further subdivided into three groups based on the duration of
Diabetes.
GROUP I: 0-5YEARS
GROUP II: 6-10YEARS
GROUP III: >10YEARS
The control group was taken from the Outpatient Dept of Medicine andinpatients
admitted for other ailments. This group was designated as GROUPIV.
Echocardiography:
Patients were evaluated by 2D and Doppler Echocardiography. Allexaminations were
performed using an ALOKA SSD 2000 machine 2.5MHztransducer. The following
were registered on assessment:
1.Ejection Fraction
2.LV mass
3.Mitral Early filling velocity (E), Mitrallate atrial filling velocity (A),E/A was then
derived
4.IVRTand
5.DT.
Operators blinded to the diabetes diagnosis of the patients performed all
Echocardiographic measurements.
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STATISTICAL ANALYSIS
The information collected regarding all the selected cases will be recorded in a
Master Chart. Data analysis will be done with the help of computer using
Epidemiological Information Package (EPI 2002).Using this software, frequencies,
percentage, mean, standard deviation, x2 and 'p' values will be calculated.
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ANNEXURE – VI
7.3 INVESTIGATIONS REQUIRED FOR THE STUDY
1) Electrocardiography.
2) Echocardiography.
3) Blood glucose levels.
4) Renal function tests.
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7.4 ETHICAL COMMITTEE
The
following
study
entitled
“DIASTOLIC
DYSFUNCTION
IN
NORMOTENSIVETYPE 2 DM” By DR. SAYYED ASEF MAULANA,PG
General Medicine, 2011 batch has been cleared from the ethical committee of this
institution for the purpose of dissertation work.
Date:
Place :
Chairman,
Ethical Committee,
Al Ameen Medical College,
Bijapur
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7.5 SAMPLE INFORMED CONSENT FORM
RESEARCH INFORMED CONSENT FORM
TITLE OF THE STUDY:-
“DIASTOLIC DYSFUNCTION IN
NORMOTENSIVE TYPE 2 DM”
PRINCIPAL INVESTIGATOR:
DR.SAYYED ASEF MAULANA
P.G. GUIDE’S NAME:
DR. VITHAL RAO
PURPOSE OF STUDY
I have been explained about the reason for doing the study and selecting me as
a subject of this study. This study is for better understanding of left ventricular
diastolic dysfunction in asymptomatic normotensive diabetes mellitus type IIwith the
help of Electrocardiography and Echocardiography.
RISKS AND DISCOMFORTS
I understand that I may experience some pain or discomfort during the
examination or during my treatment. This is mainly the result of my condition and the
procedure of the study is not expected to exaggerate these feelings which are
associated with the usual course of treatment. The risk and possible complications
surgically and anesthetically have been explained to me.
BENEFITS
I understand that my participationin the study will have no direct benefit to me
other than the potential benefit of treatment.
ALTERNATIVES
The various alternative modes of treatment available to me in my disease with
merits and demerits have been explained to me.
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CONFIDENTIALITY:
I understand medical information produced by this study will become part of
my hospital record and will be subject to the confidentiality and privacy regulations of
the hospital.
If the data are used for publication in the medical literature for teaching
purposes, no names will be used, and other identifiers, such as photographs and audio
or videotapes, will be used only with my special written permission. I understand I
may see the photographs and videotapes and hear the audio tapes before giving this
permission. For this purpose every effort will be made by publishing person to
contact me in the address furnished by me through postal communication. If no
response is received within a reasonable time, all the identities will be removed from
the photographs and case report before being submitted for publication.
REQUEST FOR MORE INFORMATION:
I understand that, I may ask more questions about the study at any time.
Researcher is available to answer my questions or concern in this research period. 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.
REFUSAL OR WITHDRAWL OF PARTICIPATION:
I understand that my participation is voluntary and I may refuse to participate
or 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 the study at any time after I have been explained the reasons for doing
so.
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INJURY STATEMENT
I understand that in the unlikely event of injury to me resulting directly from
my participation in this study. If such injury were reported promptly, then medical
treatment would be available to me, but no further compensation would be provided.
I understand that my agreement to participate in the study I am not waiving any of my
legal rights.
Explained to _________________________________________
(Patient’s Name)
The purpose of research, the procedures required and the possible risk and
benefits have been explained to the best of my ability.
Investigator -------------------------------------------------
Date:
I have been explained clearly about the reason for doing this study, reason for
selecting me as a subject in the study. I also have been explained about the risks,
benefits and confidentiality of the study. Alternative procedures that might be used in
the treatment of my disease also explained to me. I am willing to attend any follow
up requested to me at a future date. Freedom is given to me for the participation in
the study or discontinues participation at any time without prejudice.
All the above explained in detail to me clearly in my own language. I am
giving consent voluntarily for inclusion of me in the study as a subject.
----------------------------------Participant
-----------------------------------
Date:
Witness to signature
18
ANNEXURE – VII
LIST OF REFERENCES
1) A.P.I. Textbook of Medicine, 8th edition. Heart Failure; Upendra Kaul 468478.
2) Plouin IF. The importance of Diabetes as a cardiovascular risk
factor.IntJ.ClinicPract.Suppl 2000(110):3-8.
3) Harrisons Principles of Internal Medicine, 18th edition. Heart failure;
Douglass L. Mann and Murali Chakinda; 1901-2015
4) JIACM 2002;3(2):164-8 Echocardiographic Doppler assessment of cardiac
function in patients of Type 2 DM
5) Ethn Dis 2005. Autumn;15(4)635-40, LV dysfunction in Type 2 DM without
Cardiac symptoms.
6) Epidemiology of LVH in Type 2 DM, Dawson A et al. Diabetolgia 2005
Oct;48(10)
7) Braunwald’s Heart Disease A Text Book of Cardiovascular Medicine,
9thedition.Heart failure with normal ejection fraction; Margaret M. Redfield
586-600. Echo changes in diastolic dysfunction; Heidim Connolly and Jae K.
Oh 220-221.
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