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
|
|
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
|
|
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 |