Download 6.2need for the study - Rajiv Gandhi University of Health Sciences

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA.
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
DR.MYTHRI.S
Name of the candidate and
address
(in block letters)
1.
POST GRADUATE STUDENT,
DEPARTMENT OF GENERAL MEDICINE,
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES ,
.
BANASHANKARI 2ND STAGE
BANGALORE(KARNATAKA)-560070
2.
Name of the Institution
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES,
BANGALORE(KARNATAKA)
3.
Course of study and subject
4.
Date of admission to the course
M.D.(General Medicine)
09-05-2011
LEFT VENTRICULAR DIASTOLIC DYSFUNCTION AND
5.
Title of the topic
CARDIOVASCULAR AUTONOMIC NEUROPATHY IN
ASYMPTOMATIC TYPE2 DIABETES MELLITUS- A CLINICAL
STUDY
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6.
BRIEF RESUME OF THE INTENDED WORK:
6.1 INTRODUCTION
Long standing diabetes mellitus is associated with micro and macro level dysfunction in multiple organ
systems. Diabetic autonomic neuropathy may manifest as disturbances in cardiovascular, gastrointestinal or
genitourinary system. Diabetic autonomic neuropathy is often an ignored complication of diabetes as the
symptoms associated with it are generally mild and are not life threatening.
Cardiac autonomic neuropathy (CAN) is one of the major complications of diabetes mellitus. It is also the
most under diagnosed and least understood diabetic complication. It generally manifests as exercise
intolerance, resting tachycardia and orthostatic hypotension. Though these manifestations themselves are not
life threatening, studies have revealed an increase in all cause mortality in the diabetic patients with CAN.
Meta-analysis of 15studies has demonstrated the direct association between the presence of CAN and
mortality. The reason for high mortality is not clear though it has been suggested that neuropathy, accelerated
nephropathy, association with microangiopathy and disturbed cardiovascular risk profile are important
contributors.
The presence of CAN is diagnosed on the basis of tests of autonomic reactivity.
The reported prevalence of diabetic CAN is varied. This is generally due to the differences in the criteria used
for the diagnosis of CAN and differences in patient cohort i.e. community based study or referral
Centre study. According to WHO the burden of diabetes mellitus in India is 31.7 million (approximately 3%
population) and projected figure for 2030 is 79.44 million.
6.2NEED FOR THE STUDY
•
Most common cause of mortality in diabetics is due cardiovascular events.
•
Cardiovascular autonomic neuropathy (CAN) has a prevalence of 8-90%
•
CAN is a serious complication of DM with high mortality risk of 27% in a period of 5yrs
like Silent cardiac ischemia, Sudden cardiac death, Arrhythmias
•
Left ventricular diastolic dysfunction is considered a precursor of diabetic cardiomyopathy.
•
Hence, the need for the study to identify diabetics at high risk.
•
Also data about Indian population is limited.
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6.3 REVIEW OF LITERATURE
Poirier P, Bogaty P et al studied three groups of 10 age-matched men each with wellcontrolled type 2 diabetes in Canada: (1) subjects with normal diastolic function, (2) subjects with LVDD
characterized by impaired LV relaxation, and (3) subjects with a more severe form of LVDD
characterized by a pseudo normalized pattern of LV filling. No subject had evidence of clinical diabetic
complications, coronary artery disease (CAD), hypertension, congestive heart failure, or thyroid or overt
renal disease. LVDD and CAN are associated in patients with otherwise uncomplicated wellcontrolled type 2 diabetes was the conclusion.
Gambardella S,Frontoni S et al investigated possible relationship between diabetic autonomic neuropathy,
circadian blood pressure changes, and echocardiograph parameters in 27 normotensive diabetic
patients (10 with and 17 without autonomic neuropathy) who underwent 24 h noninvasive ambulatory
blood pressure monitoring and M-mode echocardiograph recording. The increased LVMI they observed
may represent a possible link between diabetic autonomic neuropathy, nocturnal blood pressure levels,
and higher cardiovascular mortality rate. This study was conducted in Italy.
AK Basu, R Bandyopadhyay et al studied on The Prevalence of Cardiac Autonomic Neuropathy in
Type-2 Diabetes in Eastern India. In this study, CAN was found in 54% cases. Parasympathetic neuropathy
was found in 52% cases and sympathetic neuropathy in 20% cases. Majority of patients (28%) had two
abnormal cardiovascular reflexes. Statistical evaluation revealed retinopathy is significantly associated with
CAN. Statistical evaluation also revealed that microalbuminuria is significantly associated with CAN.
Parasympathetic cardiac autonomic function tests are more sensitive for the detection of CAN than
sympathetic cardiac autonomic function tests. Evaluation of cardiovascular reflexes constitutes an important
feasible and reproducible beside clinical technique.
6.4
AIMS AND OBJECTIVES:
TO FIND OUT THE ASSOCIATION BETWEEN LEFT VENTRICULAR DIASTIOLIC
DYSFUNCTION AND CARDIO VASCULAR AUTONOMIC NEUROPATHY IN
ASYMPTOMATIC TYPE 2 DM
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______________________________________________________________
7.
MATERIALS AND METHODS:
7.1 SOURCE OF DATA:
Inpatients admitted in Department of Medicine , Kempegowda Institute of Medical sciences and diagnosed
with type 2 Diabetes Mellitus
Type of Study: A Descriptive study design
INCLUSION CRITERIA:

Type2 DM

Age >30 yrs and <65yrs
EXCLUSION CRITERIA:
Macro vascular complications
Hypertension
Structural heart disease
Congestive heart failure
History of heart disease
Patients on antihypertensive drugs
7.2 METHODS OF COLLECTION OF DATA:
The data for this study will be collected on purposive sampling basis from patients with type 2 Diabetes
Mellitus, who fulfill the inclusion and exclusion criteria and who are willing to participate in the study.
Statistical method
Descriptive statistical characteristics and variables of the patients will be described.
The biochemical and other parameters can be compared using chi square test
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.
YES (As and when required)
•
•
•
•
•
•
•
FBS & PPBS
HbA1C
Sr.Creatinine
Urine routine-random sample
2D echo
ECG
Fundoscopy
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•
•
•
Lipid profile
Gastric tonometry and urodynamic studies will be done where required.
Other relevant investigations
7.4 Has ethical clearance been obtained from ethical committee of your institution in case of
7.3?
YES, Clearance has been obtained from the ethical committee of Kempegowda Institute of Medical Sciences,
Bangalore
7.5 DURATION OF STUDY: Two years (November 2011 to November2013)
8.
LIST OF REFERENCES
1. Dihn W, Füth R et al. Cardiovascular autonomic neuropathy contributes to left ventricular diastolic
dysfunction in subjects with Type 2 diabetes and impaired glucose tolerance undergoing coronary
angiography. Diabet Med. 2011 Mar; 28(3):311-8.
2. Gambardella S. Increased left ventricular mass in normotensive diabetic patients
with autonomic neuropathy. Am J Hypertens .1993 Feb;6(2):97-102.
3. Poirier.p, bogaty p eta l. Relation of left ventricular diastolic dysfunction to cardiac
autonomic neuropathy in men with uncomplicated well-controlled type 2 diabetes. Metabolism. 2003 Aug;
52(8):1056-61.
4. AK Basu, R Bandyopadhyay et al. A Study on the prevalence of cardiac autonomic neuropathy in type 2
Diabetes in eastern India. JIACM.2010;11(3):190-4
5. Vinik AI, Maser RE et al. Diabetes Care. 2003 May; 26(5):1553-79. Diabetic autonomic neuropathy.
6. Ewing DJ, Campbell IW. Assessment of cardiovascular effects in diabetic autonomic neuropathy and
prognostic implications.Ann Intern Med.1980 Feb;92(2 Pt 2):308-11
9.
Signature of the candidate
10.
Remarks of the guide
DR. MYTHRI.S
APPROVED
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11.
Name and Designation
11.1 Of the Guide
DR. N.C.SRINIVASA PRABHU
PROFESSOR,
DEPARTMENT OF MEDICINE,
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES,
BANASHANKARI 2ND STAGE,
BANGALORE- 560070
11.2 Signature
11.3 Head of the Department
11.4
DR. POORNACHANDRA.M.V.
PROFESSOR AND HEAD OF THE DEPARTMENT,
DEPARTMENT OF MEDICINE,
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES,
BANASHANKARI 2ND STAGE,
BANGALORE- 560070
Signature
12.
12.1 Remarks of the Principal
and Chairman
12.2 Signature
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