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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 func­tion 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 base­line 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 con­secutive 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.

 
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