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CTRI Number  CTRI/2020/03/023738 [Registered on: 03/03/2020] Trial Registered Prospectively
Last Modified On: 14/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Occurrence of heart related risk factors in Diabetes mellitus 
Scientific Title of Study   Prevalence of cardiovascular risk factors in Diabetes mellitus 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jaspreet Kaur 
Designation  Assistant Professor 
Affiliation  Guru Jambheshwar University Of Science and Technology 
Address  Department Of Physiotherapy
Guru Jambheshwar University Of Science and Technology Hisar Haryana
Hisar
HARYANA
125001
India 
Phone  09466092657  
Fax    
Email  jaspreet_malik16@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mamta Boora 
Designation  Assistant Professor 
Affiliation  Guru Jambheshwar University Of Science and Technology  
Address  Department Of Physiotherapy
Guru Jambheshwar University Of Science and Technology Hisar Haryana
Hisar
HARYANA
125001
India 
Phone  8683810061  
Fax    
Email  mamtaboora50@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mamta Boora 
Designation  Assistant Professor 
Affiliation  Guru Jambheshwar University Of Science and Technology  
Address  Department Of Physiotherapy
Guru Jambheshwar University Of Science and Technology Hisar Haryana
Mahendragarh
HARYANA
125001
India 
Phone  8683810061  
Fax    
Email  mamtaboora50@gmail.com  
 
Source of Monetary or Material Support  
Department Of Physiotherapy  
 
Primary Sponsor  
Name  Department Of Physiotherapy  
Address  Department Of Physiotherapy Guru Jambheshwar University Science and Technology Hisar Haryana 
Type of Sponsor  Other [University] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mr Ravinder Pal  Department Of Physiotherapy  Department Of Physiotherapy Guru Jambheshwar University Science and Technology Hisar Haryana
Hisar
HARYANA 
8813947186

rkmboj2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  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 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age between 18 to 70
Patients with Diabetes Mellitus-Type 2 and who consented to participate the study 
 
ExclusionCriteria 
Details  Below age 18 and above 70
Pregnant women are excluded from the study to avoid the possible impact of pregnancy on anthropometric measurement
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Cardiovascular risk factors in Diabetes Mellitus
 
o week,one week 
 
Secondary Outcome     
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   06/03/2020 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Introduction

 Diabetes Mellitus (DM) is a metabolic disorder characterized by the presence of chronic hyperglycemia either immune-mediated (Type 1 diabetes), insulin resistance (Type 2), gestational or others (environment, genetic defects, infections, and certain drugs).

Diabetes is a serious, chronic disease that occurs either when the pancreas does not produce enough insulin (a hormone that regulates blood sugar, or glucose), or when the body cannot effectively use the insulin it produces. Diabetes is an important public health problem, one of four priority noncommunicable diseases (NCDs) targeted for action by world leaders. Both the number of cases and the prevalence of diabetes have been steadily increasing over the past few decades.

Diabetes mellitus is one of the most prevalent metabolic, non-communicable disorders in the world. It is estimated, in 2014 there are 422 million adults that having diabetes (nearly doubled since 1980). Prevalence of diabetes has risen faster in low and middle income countries. There are about 1.5 million deaths accounted in 2012 due to diabetes. Increased blood glucose caused an additional 2.2 million deaths due to cardiovascular and other diseases.

Cardiovascular disease (CVD) is a major cause of death and disability among people with diabetes. Adults with diabetes historically have a higher prevalence rate of CVD than adults without diabetes, and the risk of CVD increases continuously with rising fasting plasma glucose levels, even before reaching levels sufficient for a diabetes diagnosis.

The increased focus on adequately treating patients with both CVD and T2DM requires that we have updated prevalence rates of CVD among patients with T2DM. This is especially needed to inform clinical and policy level decision-making by healthcare providers, healthcare policy decision-makers, and health economic analysts. Reviews have been published on the epidemiology of type1 diabetes (T1DM), and CVD.


                                               Need of the study

An understanding of the changing epidemiology of cardiovascular risk factors in diabetes in Haryana is required.

Estimation of the prevalence of diabetes and identification of high risk groups is essential for planning of cardiovascular risk factors reduction interventions. There is currently insufficient information available on prevalence of cardiovascular risk factors in type 2 diabetes and associated factors in Haryana

 
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