FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2013/11/004150 [Registered on: 19/11/2013] Trial Registered Prospectively
Last Modified On: 14/07/2015
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Observational 
Study Design  Other 
Public Title of Study   A clinical study to learn more about prevalence of diabetes and heart disease in Indian population 
Scientific Title of Study   Medanta Cardiometabolic Disease Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MED/2013/002  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjay Mittal 
Designation  Director-Clinical Cardiology and Research  
Affiliation  Medanta-The Medicity 
Address  Medanta-The Medicity Sector – 38, Gurgaon Haryana 122 001 India

Gurgaon
HARYANA
122 001
India 
Phone  01244141414  
Fax  01244834111  
Email  sanjay.mittal@medanta.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjay Mittal 
Designation  Director-Clinical Cardiology and Research  
Affiliation  Medanta-The Medicity 
Address  Medanta-The Medicity Sector – 38, Gurgaon Haryana 122 001 India

Gurgaon
HARYANA
122 001
India 
Phone  01244141414  
Fax  01244834111  
Email  sanjay.mittal@medanta.org  
 
Details of Contact Person
Public Query
 
Name  Mr Kuldeep Kumar 
Designation  Project Leader  
Affiliation  Medanta Duke Research Institute 
Address  Medanta Duke Research Institute Pvt. Ltd. 10th Floor, A Wing, Medanta-The Medicity Sector – 38, Gurgaon Haryana 122 001 India
Medanta Duke Research Institute Pvt. Ltd. 10th Floor, A Wing, Medanta-The Medicity Sector – 38, Gurgaon Haryana 122 001 India
Gurgaon
HARYANA
122 001
India 
Phone  9971918887  
Fax  01244834111  
Email  kuldeep.chauhan@medanta.org  
 
Source of Monetary or Material Support  
Jubilant Life Sciences. Ltd 
 
Primary Sponsor  
Name  Medanta Duke Research Institute 
Address  Medanta Duke Research Institute 10th Floor ‘A’ Wing POC Unit Medanta-The Medicity Sector – 38, Gurgaon Haryana 122 001, India  
Type of Sponsor  Research institution 
 
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 
Dr Sanjay Mittal  Medanta-The Medicity   Third Floor Medanta-The Medicity Sector – 38, Gurgaon Haryana 122 001, India
Gurgaon
HARYANA 
9910044477

Sanjay.mittal@medanta.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medanta Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Type 2 Diabetes and Coronary Artery Disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  I. Are 18-80 years old,
II. Have the ability to give informed consent and
III. Are a patient at the Medanta-The Medicity Hospital outpatient clinic, cardiac catheterization laboratory or at the rural camps organized by the Medanta-The Medicity Hospital you are eligible to participate in the study.
IV. Are undergoing a cardiac catheterization, it should be because there is a concern for coronary artery disease and the cardiac catheterization should not be an emergency procedure.
 
 
ExclusionCriteria 
Details  I. Are being unable to give informed consent,
II. Are undergoing an emergency cardiac catheterization,
III. Are having severe anemia,
IV. Are having a planned surgery within 24 hours of cardiac catheterization.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Novel biomarkers profiling of type 2 diabetes and coronary artery disease  Novel biomarkers profiling of type 2 diabetes and coronary artery disease 
 
Secondary Outcome  
Outcome  TimePoints 
Identification of patients of Indian origin who are at greater risk of developing type 2 diabetes and coronary artery disease  Identification of patients of Indian origin who are at greater risk of developing type 2 diabetes and coronary artery disease 
 
Target Sample Size   Total Sample Size="700"
Sample Size from India="700" 
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)
Modification(s)  
27/11/2013 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Cardiovascular disease and diabetes are reaching epidemic proportions in the United States and in developing countries.  India, in particular, has shown marked increases in the rates of these two diseases with major public health impact. The epidemiology and mechanism underlying these trends are incompletely understood.   It is known that CAD risk has a strong genetic component .  Research work at Duke University, NC, USA in Caucasian population has already suggested that novel mechanisms of diabetes and cardiovascular disease risk and have also identified novel diagnostic and prognostic biomarkers.  Through this proposal, we will expand Duke’s previous work in the clinical and molecular epidemiology of type II diabetes and cardiovascular disease (CVD) in Indian populations.  This work will help us to better define the epidemiology of diabetes and CVD in Indian populations and advance our understanding of molecular mechanisms related to the dramatic increase in diabetes and CVD risk in transitioning Indian populations,

The primary goals of this component of the study proposal are :

1)      To identify novel biomarkers of type II diabetes and coronary artery disease in an Indian population referred for cardiac catheterization at Medanta Hospital.  Metabolomic profiling and gene expression assays on 400 participants referred for cardiac catheterization in 2x2 factorial design of type II diabetes and coronary artery disease (+DM/+CAD vs. +DM/-CAD vs. –DM/+CAD vs. –DM/-CAD).

 

2)      To conduct a small-scale pilot “proof-of-principle” effort of clinical and electrocardiographic data and biological sample collection in rural Delhi. Clinical, biochemical and ECG evaluation of 300 participants in Medanta cardiovascular disease outreach camp.

 

In this study, we will analyse the blood samples from the study population for genetic and metabolomic profiling.

 

Our research will help to identify patients of Indian origin who are at high risk for developing disease and will add to the epidemiologic and biomarker data of CVD in urban and rural India. This study therefore has great implications for disease prevention and for public health improvement in India. 
Close