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CTRI Number  CTRI/2019/03/018095 [Registered on: 15/03/2019] Trial Registered Retrospectively
Last Modified On: 14/03/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Diabetes prevalence in India 
Scientific Title of Study   ICMR-INDIAB Study -A large cross-sectional epidemiological study with the objectives to determine the national prevalence of type 2 diabetes mellitus & pre-diabetes in India and complications of diabetes in the metros  
Trial Acronym  ICMR–INDIAB Study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr V Mohan 
Designation  PRESIDENT 
Affiliation  Madras Diabetes Research Foundation 
Address  Madras Diabetes Research Foundation Department of Diabetology
No 4 Conran Smith Road Gopalapuram
Chennai
TAMIL NADU
600086
India 
Phone  914443968888  
Fax  914428350935  
Email  drmohans@diabetes.ind.in  
 
Details of Contact Person
Scientific Query  
Name  Dr V Mohan 
Designation  President 
Affiliation  Madras Diabetes Research Foundation 
Address  Madras Diabetes Research Foundation Department of Diabetology
No 4 Conran Smith Road Gopalapuram
Chennai
TAMIL NADU
600086
India 
Phone  914443968888  
Fax  914428350935  
Email  drmohans@diabetes.ind.in  
 
Details of Contact Person
Public Query  
Name  DrGuha Pradeepa 
Designation  Head Research Operations 
Affiliation  Madras Diabetes Research Foundation 
Address  Madras Diabetes Research Foundation Department of Research Operations
No 4 Conran Smith Road Gopalapuram
Chennai
TAMIL NADU
600086
India 
Phone  914443968888  
Fax  914428350935  
Email  guhapradeepa@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Reserach 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Ansari Nagar New Delhi 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Department of Health Research Government of India  2nd Floor IRCS Building Red Cross Road New Delhi Delhi 110003 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 30  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nikhil Tandon  All India Institute of Medical Sciences   Ansari Nagar New Delhi 110029
New Delhi
DELHI 		 01126588663

nikhil_tandon@hotmail.com 
Dr Kalpana Dash  Apollo Hospital  Seepat Road Bilaspur (C.G.)
Bilaspur
CHHATTISGARH 		 9630013474

drkdash@rediffmail.com 
Dr Sanjay Kalra  Bride Bharti hospital  Wazir Chand Colony Kunjpura Road Model Town Karnal 132001
Karnal
HARYANA 		 09215848555

brideknl@gmail.com 
Dr Anil Bhansali  Christian Medical College   Brown Rd CMC Campus Ludhiana 141008
Ludhiana
PUNJAB 		 01722778786

anilbhansali_endocrine@rediffmail.com 
Dr Rosangluaia  Civil Hospital Aizawl   Bazar Bungkawn Bara Bazar Dawrpui Aizawl 796001
Aizawl
MIZORAM 		 09436151180

drrosang@rediffmail.com 
Dr Ajay Kumar  Diabetes Care and Research Centre   64, P C Colony Kankarbagh Road, Housing Board Colony, RBI Flats Colony, Patrakar Nagar, Patna
Patna
BIHAR 		 9431020510

drajaykr@yahoo.com 
Dr VK Dhandhania  Diabetes Care Centre  SHEETAL COMPLEX AGRASEN PATH NEAR SEVA SADAN HOSPITAL
Ranchi
JHARKHAND 		 9431115394

vsudha72@yahoo.com 
Dr Banshi Saboo  DIACARE  1 Gandhi Park Nr Nehru Nagar Road Ambawadi Ahmedabad 380015
Ahmadabad
GUJARAT 		 07926304104

banshisaboo@hotmail.com 
Dr Vizolie Suokhrie  Directorate of Health and Family Welfare Govt of Nagaland  Ruziezou Kohima 797001
Kohima
NAGALAND 		 09436005707

npcdcsnagaland@gmail.com 
Dr LobsangJampa  Directorate of Health Services  Lumar Dai lane Naharlagun
Papum Pare
ARUNACHAL PRADESH 		 9436055743

ljampa2013@gmail.com 
Dr Ankush Desai  Goa Medical College  Bambolim Goa 403202
North Goa
GOA 		 08322495077

ankush_desai@rediffmail.com 
Dr Taranga Reang  Government Medical College  GBP Hospital PO Kunjaban Agartala 799 006
West Tripura
TRIPURA 		 09436134540

tarangareang@gmail.com 
Dr PK Jabbar  Government Medical College Trivandrum  Ulloor Akkulam Road Chalakkuzhi Thiruvananthapuram 695011
Thiruvananthapuram
KERALA 		 09446828766

drjabbar10@gmail.com 
Dr Sagar Modi  Himalayan Institute of Medical Sciences  Swami Ram Nagar Joly Grant Doiwala Uttarakhand 248140
Dehradun
UTTARANCHAL 		 09818941411

sagarmodi1980@gmail.com 
Dr Karma Jigme Tobgay  Human Services and Family Welfare Govt of Sikkim  Annexe Building Health Tadong Gangtok 737 102
East
SIKKIM 		 09434756660

npcdcssikkim@gmail.com 
Dr Prashant P Joshi  Indira Gandhi Govt Medical College  9A Hindustan Colony Amravati Road NAGPUR 440033
Nagpur
MAHARASHTRA 		 9822225504

drprashantpjoshi@gmail.com 
Dr Jatinder Kumar Moktha  Indira Gandhi Medical College  Ridge Sanjauli Road Lakkar Bazar Shimla 171001
Shimla
HIMACHAL PRADESH 		 09418084123

jkmokta@yahoo.co.in 
Dr Shubankar Chowdhary   Institute of Post Graduate Medical Education and Research  244 AJC Bose Road Kolkata 700 020
Kolkata
WEST BENGAL 		 09831076501

subhankar.chowdhury@gamil.com 
Dr Arvind Gupta  Jaipur Diabetes Research Centre  6 JDA Market Mansarovar Link Road Gopalpura Bypass 302020
Jaipur
RAJASTHAN 		 01412763336

arvindneelum@hotmail.com 
Dr Prabha Adhikari  Kasturba Medical College  03 Light House Hill Rd Hampankatta Mangaluru Karnataka 575001
Udupi
KARNATAKA 		 09880991290

pabha_raghuveer@yahoo.co.in 
Dr V Mohan  Madras Diabetes Research Foundation  No 4 Conran Smith Road, Gopalapuram 600 086
Chennai
TAMIL NADU 		 4443968888
28350935
drmohans@diabetes.ind.in 
Dr Somorjit Ningombam  Medical and Health Services  Loklaobung Moirangkhom Imphal 795001
Imphal East
MANIPUR 		 09436036380

drsomorjit@gmail.com 
Dr Sarita Bajaj  MLN Medical College  3 Panna Lal Road Allahabad 211 002
Allahabad
UTTAR PRADESH 		 05322256461

bajajak1945@yahoo.co.in 
Dr PV Rao  Nizam’s Institute of Medical sciences  Punjagutta Hyderabad
Hyderabad
TELANGANA 		 988505110

Diabetology@eth.net 
Dr RO Budnah  Office of the Director of Health Services   Red Hill Laitumkrah Shillong
East Khasi Hills
MEGHALAYA 		 09863020940

richardbudnah2014@gmail.com 
Dr Anil Bhansali  PGIMER  Sector 12 Chandigarh 160012
Chandigarh
CHANDIGARH 		 9478111956

anilbhansali_endocrine@rediffmail.com 
Dr Anil J Purty  Pondicherry Institute of Medical Sciences   Kalathumettupathai Ganapathichettikulam Village No20 Kalapet 605014
Pondicherry
PONDICHERRY 		 09442233460

anilpurty@hotmail.com 
Dr H K Das  Regional Medical Research Centre  NE Region ICMR Post Box No 105 Dibrugarh
Dibrugarh
ASSAM 		 9435002588

drhkd66@gmail.com 
Dr Sidhartha Das  S C B Medical College and Hospital  Medical Road Sri Rama Chandra Bhanja New Auditorium Mangalabag Cuttack 753007
Cuttack
ORISSA 		 09778623285

drsidhartha.cuttack@gmail.com 
Dr Sunil M Jain  TOTALL Diabetes Thyroid Hormone Research Institute Pvt Ltd  Scheme No 54 Indore Madhya Pradesh 452010
Indore
MADHYA PRADESH 		 07312433181

sunilmjain@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 27  
Name of Committee  Approval Status 
AIIMS Institutional Ethics Committee  Approved 
Apollo Hospitals Bilaspur ethics committee  Approved 
CMC Ludhiana Ethics Committee  Approved 
Diabetes Thyroid Harmone Research Institute Ethics Committee  Approved 
DIACARE Research Ethics Committee  Approved 
Goa medical College Institutional Ethics Committee  Approved 
KMC Institutional Ethics Committee  Approved 
Madras Diabetes Research Foundation Human Ethics Committee   Approved 
Madras Diabetes Research Foundation Human Ethics Committee   Approved 
Madras Diabetes Research Foundation Human Ethics Committee   Approved 
Madras Diabetes Research Foundation Human Ethics Committee   Approved 
Madras Diabetes Research Foundation Human Ethics Committee   Approved 
Madras Diabetes Research Foundation Human Ethics Committee   Approved 
Madras Diabetes Research Foundation Human Ethics Committee   Approved 
NIMS Institutional Ethical Committe  Approved 
PIMS Institute Ethics Committee  Approved 
RMRC NE Region Institutional Ethics committee  Approved 
RMRC NE Region Institutional Ethics committee  Approved 
RMRC NE Region Institutional Ethics committee  Approved 
RMRC NE Region Institutional Ethics committee  Approved 
RMRC NE Region Institutional Ethics committee  Approved 
RMRC NE Region Institutional Ethics committee  Approved 
RMRC NE Region Institutional Ethics committee  Approved 
RMRC NE Region Institutional Ethics committee  Approved 
SCB Medical Institutional Ethics Committee  Approved 
SRHU Ethics Committee  Approved 
TMC Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  May be normal, have prediabetes or diabetes 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  willing to give informed consent
Individuals aged 20 years and above  
 
ExclusionCriteria 
Details  Not able to give informed consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of Pre-diabetes,diabetes and associated complications  2008- 2020 
 
Secondary Outcome  
Outcome  TimePoints 
Prevalence rates of diabetes and prediabetes  2020 
 
Target Sample Size   Total Sample Size="124000"
Sample Size from India="124000" 
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)   13/10/2008 
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="12"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   So far ten articles have been published in National and International journals.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study is an ongoing cross sectional study, which aims to estimate the national prevalence of diabetes and prediabetes in India by estimating the state wise prevalence of the same ( 28 states, 1 NCT of Delhi and 2 Union Territories) . This study will also  determine the prevalence of hypertension, dyslipidemia, and coronary artery disease among subjects with and without diabetes and to assess the level of diabetes control among self-reported diabetic subjects.

The following are the different phases/component in the ICMR INDIAB Study.

Phase I of the study which included Tamil Nadu, Chandigarh, Jharkhand and Maharashtra has been completed.

North East component of the study has also been completed in eight study including Assam, Arunachal Pradesh, Manipur, Meghalaya, Mizoram, Nagaland, Sikkim and Tripura.

Phase II of this study which includes 19 states/UT is ongoing: The study has been completed nine states including Andhra Pradesh (undivided), Bihar, Punjab, Karnataka, Gujarat, Delhi , Madhya Pradesh, Uttar Pradesh and Rajasthan: ongoing in Kerala, Goa, Puducherry, Chhattisgarh and Haryana and the pending five states include West Bengal, Odisha, Uttarakhand,  Himachal Pradesh and Jammu and Kashmir 

 


 
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