18100006003 THESIS
TITLE
“ASYMPTOMATIC LEFT VENTRICULAR (LV) DIASTOLIC
DYSFUNCTION IN PATIENTS OF TYPE 2 DIABETES
MELLITUS OF 1 TO 10 YEARS DURATION”
INTRODUCTION
In the year 2000, India topped the world with the highest number of people
with Diabetes Mellitus with 31.7 million people affected with it, giving it a
status of a potential epidemic. [1] In 2014, this figure more than doubled
to 62 million of the adult population diagnosed with Diabetes. According
to Wild et. al. this figure may reach nearly 80 million by the end of 2030,
further establishing its status as a potential epidemic. [2]
According to the recently conducted National Family Health Survey,
(NFHS-4, 2015-16) 6.3% of adult women in Nalgonda suffer from
Diabetes Mellitus, with Khammam having the highest prevalence at 7.6%
of its adult population. [3]
Left ventricular diastolic dysfunction in asymptomatic patients with
diabetes mellitus may represent the early stage of diabetic
cardiomyopathy even in patients without structural cardiac disease or
systemic hypertension and have a preserved left ventricular systolic
function. [4]
Diabetic cardiomyopathy was first reported by Rubler et al. [5] in 1972
when they described four diabetic patients with heart failure, normal
coronary arteries, and without obvious aetiology for heart failure and
stated that it was due to diabetic cardiomyopathy.
Studies have reported a high prevalence of pre-clinical LV diastolic
impairment in diabetic patients [6] and this cardiac complication may
represent the reversible early stage of heart failure which is termed
diabetic cardiomyopathy.
Cardiac involvement in patients with diabetes mellitus may occur
relatively early in the course of disease, impairing left ventricular (LV)
relaxation (diastolic dysfunction) and later on can affect ventricular
contraction (systolic dysfunction). [6]
AIM
To Study Asymptomatic Left Ventricular (LV) diastolic dysfunction in
patients of Type 2 Diabetes Mellitus of 1 to 10 years duration.
OBJECTIVES
To study asymptomatic diastolic dysfunction in patients with Type 2
Diabetes Mellitus.
RESEARCH QUESTIONS
1. Is there a correlation between glycaemic control and grade of
diastolic dysfunction?
2. Does duration alone affect the grade of diastolic dysfunction?
3. Does grade 3 diastolic dysfunction (restrictive filling pattern) occur
in diabetics of less than 10 years duration?
METHODOLOGY – PATIENTS AND METHODS
PATIENTS: Type 2 Diabetes Mellitus patients (insulin dependent or
non-dependent), that are free from cardiac symptoms (e.g.,
exertional Dyspnea, Angina) with duration between 1-10 years, of
out-patients or in-patients admitted in Medical wards or ICU in KIMS,
Narketpally.
✓ STUDY DURATION: Recruitment of patients would begin from
October 2018 - September 2020.
✓ STUDY DESIGN: Qualitative, Cross-sectional, Exploratory
✓ SAMPLE SIZE: 60
✓ INSTITUITIONAL ETHICAL COMMITTEE CLEARANCE &
PATIENTS OFFERING VOLUNTARY WRITTEN INFORMED
CONSENT TO PARTICIPATE IN THIS STUDY
INCLUSION CRITERIA
1. Age >40 years
2. Patients diagnosed with Type 2 Diabetes Mellitus of 1 to 10 years
duration.
EXCLUSION CRITERIA
1. Patients with CAD diagnosed by symptoms, ECG or regional wall
motion abnormalities on echocardiogram or prior coronary
angiography.
2. Patients with heart failure diagnosed by signs and symptoms,
chest radiograph or echocardiography.
3. Patients with significant valvular heart disease, diagnosed clinically
or with echocardiography.
4. Heart rate <50 or >100 beat per minute, atrial fibrillation and other
arrhythmias that may interfere with Doppler studies.
5. Hypertensive patients (Either a known case on treatment or when
blood pressure is greater than 140/90 mmHg) [7]
6. Patients with long history of diabetes mellitus (>10 years) or duration
of < 1 year.
7. Subjects with poor transthoracic echocardiographic window.
STUDY PROTOCOL
This study will include all patients of Type 2 Diabetes Mellitus,
greater than 40 years of age falling into criteria set by American
Diabetic Association. [8]
All patients will be subjected to the following investigations:
i. Hemogram
ii. Complete Urine Examination
iii. Diabetic Profile – FBS, PPBS. HbA1c
iv. Blood Urea, Serum Creatinine and Serum Electrolytes
v. Fasting Lipid Profile
DIAGNOSTIC CRITERIA FOR TYPE 2 DIABETES MELLITUS
Fasting blood sugar (FBS) ≥ 126 mg/dL
(or)
Post-prandial blood sugar ≥ 200 mg/dL
(or)
HbA1c ≥ 6.5% or Classic diabetes symptoms + random plasma glucose
≥ 200 mg/dL
DIAGNOSTIC CRITERIA USED IN 2D-ECHOCARDIOGRAPHY
Subjects will be examined using standard parasternal long axis,
short axis and apical two and four chambers views. Conventional
techniques (two-dimensional-2D, M-mode echocardiography,
Pulsed-wave Doppler wave (PW) and TDI methods will be used for
1. LV internal dimensions: LV end systolic dimension (LVESD) and
LV end diastolic dimension (LVEDD).
2. Ejection fraction (EF %) (Using Teichholz method).
3. E point (m/sec): Early diastolic velocities of mitral inflow (Doppler-
derived).
4. Septal and lateral e point by tissue Doppler (m/sec): Early diastolic
myocardial velocity, derived from tissue Doppler imaging.
5. E/e ratio: Ratio of early diastolic velocities of mitral inflow (PW-
derived) and myocardial movement (TDI-derived) taken as left
ventricular filling pressure.
6. Left atrial (LA) volume index (mL/BSA): In apical four and two-
chamber views.
7. Peak tricuspid regurgitation (TR) velocity (m/sec). Systolic
dysfunction was defined if LV Ejection fraction <50%.
DEFINITION OF LV DIASTOLIC DYSFUNCTION
Definition of LV diastolic dysfunction will be indicated if 3 or more of
these variables are abnormal :
→ Septal e <7 cm/sec
→ Lateral e <10 cm/sec
→ E/e ratio >14
→ E/A ratio < 0.8
→ LA volume index >34 mL/m2
→ Peak TR velocity >2.8 m/sec.
Diastolic dysfunction will be divided into three grades :
• Grade I; impaired LV relaxation.
• Grade II ; pseudonormal filling pattern.
• Grade III ; restrictive filling pattern.
PARAMETERS USED FOR DATA ANALYSIS
The parameters used will be categorised separately for men and women.
→ Age
→ Duration
→ Body Mass Index (BMI)
→ Haemoglobin A1c (HbA1c)
→ E/A ratio
→ E/e ratio
→ Left Atrium Size (LA Volume Index)
→ Tricuspid Regurgitation Velocity (TR Velocity)
→ Left Ventricular Ejection Fraction (LVEF / EF)
→ Diastolic Dysfunction
* p value <0.05 is considered statistically significant and p value
<0.001 is considered highly significant.
LINK TO COMPLETE THESIS WITH MASTER CHART
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