| 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
|
|
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
|
|
|
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. |