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CTRI Number  CTRI/2018/08/015536 [Registered on: 30/08/2018] Trial Registered Prospectively
Last Modified On: 25/01/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Global Health Research for Cardiovascular Disease and Diabetes 
Scientific Title of Study   Understanding the patterns and determinants of health in South Asian people - South Asia Biobank.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrVMohan 
Designation  President  
Affiliation  Madras Diabetes Research Foundation 
Address  Madras Diabetes Research Foundation No 4 Conran Smith Road, Gopalapuram, Chennai

Chennai
TAMIL NADU
600086
India 
Phone  91444396888  
Fax    
Email  drmohans@diabetes.ind.in  
 
Details of Contact Person
Scientific Query
 
Name  DrVMohan 
Designation  President  
Affiliation  Madras Diabetes Research Foundation 
Address  Madras Diabetes Research Foundation No 4 Conran Smith Road, Gopalapuram

Chennai
TAMIL NADU
600086
India 
Phone  91444396888  
Fax    
Email  drmohans@diabetes.ind.in  
 
Details of Contact Person
Public Query
 
Name  DrVMohan 
Designation  President  
Affiliation  Madras Diabetes Research Foundation 
Address  Madras Diabetes Research Foundation No 4 Conran Smith Road, Gopalapuram

Chennai
TAMIL NADU
600086
India 
Phone  91444396888  
Fax    
Email  drmohans@diabetes.ind.in  
 
Source of Monetary or Material Support  
National Institute for Health Research,University of Southampton, Alpha House, Southampton, SO16 7NS, UK  
 
Primary Sponsor  
Name  National Institute for Health Research 
Address  University of Southampton, Alpha House, Southampton, SO16 7NS, UK 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Imperial College  Kensington, London SW7 2AZ, UK 
 
Countries of Recruitment     India
Bangladesh
Pakistan
Sri Lanka  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sujeet Jha  Devki Devi Foundation  Department of Diabetes & Endocrinology, No 2 Press Enclave road Saket
New Delhi
DELHI 
01126515050

drsujeetjha@gmail.com 
Dr V Mohan  Madras Diabetes Research Foundation  Department of Diabetology,No 4 Conran Smith Road, Goppalapuram
Chennai
TAMIL NADU 
4443968888

drmohans@diabetes.ind.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Madras Diabetes Research Foundation Human Ethics Committee   Approved 
Max Super Speciality Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Screening for diabetes and cardiovascular disease 
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Permanent resident of the surveillance site (resident for >12 months)
South Asian ancestry

 
 
ExclusionCriteria 
Details  Planning to leave the study site within the next 12 months
Cancer or other serious illness expected to reduce life expectancy to <12 months
Unable or unwilling to give consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Robust data on burden and quality of care of T2D and CVD in South Asia.
 
2 years
 
 
Secondary Outcome  
Outcome  TimePoints 
Enable researchers, healthcare providers and policy makers to
Identify needs, secular trends and priorities
Evaluate effectiveness of interventions, including demonstration projects
 
2 years 
 
Target Sample Size   Total Sample Size="160000"
Sample Size from India="70000" 
Final Enrollment numbers achieved (Total)= "99641"
Final Enrollment numbers achieved (India)="15073" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/09/2018 
Date of Study Completion (India) 30/09/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/09/2021 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
11 publications 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This project is done in collaboration with Imperial College, London UK and represents a collaboration between academic and clinical experts in NCD prevention and control from leading institutions in Bangladesh, India, Pakistan and Sri Lanka. With initial 4 year funding from the UK National Institutes for Health Research, we will pursue a program of translational research in South Asian that aims to:

1. Strengthen NCD surveillance systems in Bangladesh, India, Pakistan and Sri Lanka, by establishing a network of >200 surveillance sites across these South Asian countries.

2. Using standardised approaches, complete structured assessments on a representative sample of ~160,000 South Asian men and women aged 18+ years, living at the >200 surveillance sites. Collect and store biological samples for epidemiological purposes.

3. In addition use a subset of the surveillance sites as Health observatories for evaluation of healthcare interventions targeted at improving prevention and control of T2D and CVD in South Asia.

4.Thereby provide the first robust, nationally representative data on the burden of T2D, CVD and their risk factors, and on the quality of care for these major NCDs to quantify needs, in South Asian populations.

5.Disseminate the data to relevant stakeholders, include health service providers and policy makers to inform resource allocation and health system priorities. In addition, use the clinical data and biological samples collected, to pursue epidemiological research into aetiological mechanisms underlying the increased risk of T2D and CVD in South Asians.

 
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