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CTRI Number  CTRI/2023/11/059500 [Registered on: 03/11/2023] Trial Registered Prospectively
Last Modified On: 02/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Cardiac dysfunction in Diabetic patients.  
Scientific Title of Study   Echocardiographic study of Left Ventricular diastolic dysfunction in Type 2 Diabetes Mellitus patients and correlation with hba1c levels. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kodukula Naga Venkat Bharath  
Designation  First year resident  
Affiliation  Park hospital, Panipat  
Address  Department of General Medicine, room no. 11, Park hospital, Panipat NH no.1, Sewah, Haryana

Panipat
HARYANA
132103
India 
Phone  7207438198  
Fax    
Email  knvb1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ajit Srivastav  
Designation  MD General Medicine  
Affiliation  Park hospital, Panipat  
Address  OPD no.1 , Park hospital, Panipat NH no.1, Sewah, Haryana

Panipat
HARYANA
132103
India 
Phone  7207438198  
Fax    
Email  drajit.mgims@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kodukula Naga Venkat Bharath  
Designation  First year resident  
Affiliation  Park hospital, Panipat  
Address  Department of General Medicine, room no. 11 , Park hospital, Panipat NH no.1, Sewah, Haryana


HARYANA
132103
India 
Phone  7207438198  
Fax    
Email  knvb1998@gmail.com  
 
Source of Monetary or Material Support  
Park hospital, Panipat  
 
Primary Sponsor  
Name  Kodukula Naga Venkat Bharath  
Address  Park hospital, Panipat NH no.1,Sewah , Haryana -132103 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Park hospital Panipat   Park hospital, Panipat NH no.1, Sewah, Haryana -132103 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kodukula Naga Venkat Bharath   Park hospital  Department of General Medicine, Room no 11, Panipat NH no.1, Sewah, Haryana.-132103
Panipat
HARYANA 		 7207438198

knvb1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Park Hospital Ethics Committee   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  2d Echocardiography   People of any gender , age more than 50, who are Diabetic, will be screened for Left ventricular diastolic dysfunction. 
Comparator Agent  HbA1C   People who have high HbA1C level will be compared with people who have normal HbA1C level for presence and grading of Left ventricular diastolic dysfunction. 
Comparator Agent  Smoking   People included in study who are smokers will be compared to Non smokers for presence and grading of Left ventricular diastolic dysfunction. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients with DM type 2 .Cases were selected as per the diagnostic criteria laid down by the American Diabetes Association. Fasting blood glucose (FBS) of 126 mg/dl or higher or a 2-hr postprandial blood glucose (PPBS) level of 200 mg/dl or higher during a 75-gm oral glucose tolerance test or random plasma glucose of 200 mg/dl or higher in a patient with symptoms of hyperglycemia or HbA1c 6.5% or higher.
 
 
ExclusionCriteria 
Details  Patients with systemic hypertension, coronary artery disease, ischemic heart disease, cardiomyopathy, valvular disorders, connective tissue disorder, CLD, CKD and thyroid dysfunction.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Diabetes mellitus type 2 is associated with left ventricular diastolic dysfunction.  Baseline  
 
Secondary Outcome  
Outcome  TimePoints 
Smoking worsens diastolic dysfunction in diabetic patients   Baseline  
 
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   Phase 1 
Date of First Enrollment (India)   11/11/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  11/11/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [knvb1998@gmail.com].

  6. For how long will this data be available start date provided 02-09-2023 and end date provided 02-09-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This study aims to find out the incidence of Left ventricular diastolic dysfunction in patients with Diabetes mellitus type 2. Patients can be newly diagnosed or have a history of DMt2. At presentation all the participants will be tested with serum HbA1c levels which gives us an idea of blood sugar control for the past 3 months. Then the patient will go on to have a 2d echocardiography done, where in parameters for diastolic dysfunction will be measured.  Presence or absence of Diastolic dysfunction will be determined by recommendations made by American society of Echocardiography and European Association of cardiovascular Imaging in 2016. The diastolic dysfunction if present will be graded as mild , moderate or Severe and compared to the earlier HbA1c levels.  There will be another comparison of severity of diastolic dysfunction between smoking and non smoking Diabetic patients. 
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