| 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
|
|
|
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)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes and Coronary Artery Disease, |
|
|
Intervention / Comparator Agent
|
|
|
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. |