CTRI Number |
CTRI/2023/07/055615 [Registered on: 24/07/2023] Trial Registered Prospectively |
Last Modified On: |
15/07/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
FINDING OF HEART PROBLEMS IN DIABETIC PATIENTS |
Scientific Title of Study
|
A CLINICAL AND AN ECHOCARDIOGRAPHIC EVALUATION OF LEFT VENTRICULAR DIASTOLIC DYSFUNCTION IN TYPE 2 DIABETES MELLITUS PATIENTS |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
GAURAV SINGH |
Designation |
POSTGRADUATE JUNIOR RESIDENT |
Affiliation |
VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL BANTHRA SHAHJAHANPUR UTTAR PRADESH |
Address |
VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL BANTHRA SHAHJAHANPUR VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL BANTHRA SHAHJAHANPUR Shahjahanpur UTTAR PRADESH 242307 India |
Phone |
9557121007 |
Fax |
|
Email |
dr.gaurav.md007@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DRALOK AGRAWAL |
Designation |
ASSOCIATE PROFESSOR |
Affiliation |
VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL BANTHRA SHAHJAHANPUR UTTAR PRADESH |
Address |
DEPARTMENT OF GENERAL MEDICINE VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL BANTHRA SHAHJAHANPUR
Shahjahanpur UTTAR PRADESH 242307 India |
Phone |
8630713915 |
Fax |
|
Email |
bambi4665@gmail.com |
|
Details of Contact Person Public Query
|
Name |
GAURAV SINGH |
Designation |
POSTGRADUATE JUNIOR RESIDENT |
Affiliation |
VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL BANTHRA SHAHJAHANPUR UTTAR PRADESH |
Address |
VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL BANTHRA SHAHJAHANPUR VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL BANTHRA SHAHJAHANPUR Shahjahanpur UTTAR PRADESH 242307 India |
Phone |
9557121007 |
Fax |
|
Email |
dr.gaurav.md007@gmail.com |
|
Source of Monetary or Material Support
|
VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL |
|
Primary Sponsor
|
Name |
DrGAURAV SINGH |
Address |
DEPARTMENT OF GENERAL MEDICINE VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL BANTHRA SHAHJAHANPUR UTTAR PRADESH |
Type of Sponsor |
Private medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India Malaysia |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
GAURAV SINGH |
VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL |
DEPARTMENT OF GENERAL MEDICINE ROOM NO. 169 VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL BANTHRA SHAHJAHANPUR Shahjahanpur UTTAR PRADESH |
9557121007
dr.gaurav.md007@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTION ETHICS COMMITEE, VAMC |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Cases of type 2 diabetes mellitus, which clinically have no symptoms of cardiovascular disease
Age -18-65 years.
|
|
ExclusionCriteria |
Details |
• Myocardial infarction by history and resting Electrocardiogram (ECG)
• Patients with angina pectoris
• Patients with hypertension
• Type 1 DM patients
• Significant alcoholic patients
• Patients with thyroid diseases
• Patients with renal failure
• Patients with other underlying heart diseases such as:
I. Congenital heart disease
II. Valvular heart disease
III. Pericardial disease – by history, chest X-ray (CXR) posteroanterior (PA) view, and echocardiography (Echo)
• Patients with regional wall motion abnormalities are excluded by Echo
• Patients not giving consent to participate
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate the clinical and an echocardiographic evaluation of left ventricular diastolic dysfunction in type 2 diabetes mellitus patients |
2 WEEKS 4 WEEKS 6 WEEKS |
|
Secondary Outcome
|
Outcome |
TimePoints |
To assess the clinical Profile of left ventricular dysfunction in type 2 diabetic patients using Echocardiogram.
2. To correlate left ventricular dysfunction with duration of diabetes
|
2WEEKS 4WEEKS 6WEEKS
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
27/07/2023 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Left ventricular diastolic function (LVDF) is
affected earlier than systolic function in the development of congestive
cardiac failure. Therefore, left ventricular diastolic dysfunction may
represent the first stage of diabetic cardiomyopathy Echocardiography is the best noninvasive way to evaluate diastolic function and
to estimate filling pressures. M-Mode, two-dimensional, and Doppler echocardiography are all helpful in evaluating
diastolic function. So the present study will be undertaken to evaluate left
ventricular dysfunction in type 2 Diabetes mellitus patients using echocardiographic
evaluation Transthoracic echocardiography will be performed by
trained operator, using a GE VERSANA BALANCE Ultrasound System. Echocardiographer
will not be aware of this study to avoid bias in the interpretation. The left
ventricular systolic funcÂtion measurement will be based on the Teichoiz method
while diastolic function will be based on the Doppler recording of left
ventricular filling dynamics. The peak velocities of left ventricle filling
during the early rapid (E wave m/seconds) and atrial contraction (A wave,
m/second) phases, the ratio of the two filling velocities (E/A ratio), E wave
deceleration time (DT in milliseconds) from the peak of the E wave to the
portion at which the deceleration velocity reaches the baseÂline and the
isovolumic relaxation time (IVRT milliseconds), the time from aortic valve
closure to the beginning of the E wave will be recorded at the end of expiration
for five conÂsecutive beats. Valsalva maneuver will be performed to unmask
pseudo normal filling.
A reduced E/A ratio of
<1 and increase in the size of LA will be considered to be evidence of left
ventricular diastolic dysfunction. |