| CTRI Number |
CTRI/2017/09/009909 [Registered on: 25/09/2017] Trial Registered Prospectively |
| Last Modified On: |
25/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
The study has both cross sectional and cohort studies |
| Study Design |
Other |
|
Public Title of Study
|
Research to combat diabetes using genetics and novel technologies |
|
Scientific Title of Study
|
NIHR Global Heath Research Unit on Global Diabetes Outcomes Research |
| Trial Acronym |
|
|
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 |
Director |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Diabetology
No 4 Conran Smith Road
Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
43968888 |
| Fax |
28350935 |
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mohan |
| Designation |
Director |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Diabetology
No 4 Conran Smith Road
Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
43968888 |
| Fax |
28350935 |
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Mohan |
| Designation |
Director |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Diabetology
No 4 Conran Smith Road
Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
43968888 |
| Fax |
28350935 |
| Email |
drmohans@diabetes.ind.in |
|
|
Source of Monetary or Material Support
|
| National Institute for Health Research Evaluation Trials and Studies Coordinating Centre University of Southampton Alpha House Enterprise Road Southampton SO17 1BJ United Kingdom |
|
|
Primary Sponsor
|
| Name |
Madras Diabetes Research Foundation |
| Address |
No 4 Conran Smith Road Gopalapuram Chenaii 600086 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| School of Medicine University of Dundee |
12 level 5 Ninewells Hospital and Medical School
Dundee DD1 9SY
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr V Mohan |
Madras Diabetes Research Foundation |
Department of Diabetology No 4 Conran Smith Road
Gopalapuram
Chennai
TAMIL NADU |
43968888
28350935
drmohans@diabetes.ind.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Madras Diabetes Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
| Patients |
Diabetes, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 Diabetes
Cohort Study
Those who have at least 4 or more follow ups in the hospital
Cross sectional study
Individuals aged ≥ 20 years
Willing to participate in the study
Usual resident of the selected locality
|
|
| ExclusionCriteria |
| Details |
Known cases of type 1 diabetes
Diabetes secondary to other causes eg.chronic pancreatitis
Under 20 years of age or over 80 years of age
Refused consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To provide a low cost, agile and sustainable solution supported by telemedicine for outreach to the poorest populations in rural India.
To determine genomic signatures of diabetes subtypes specific to the Indian sub-continent including those defined by therapeutic response to established anti-diabetic medications. |
4 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish genetic determinants of genetic complications |
3 years |
|
|
Target Sample Size
|
Total Sample Size="30000"
Sample Size from India="30000"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="15091" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2017 |
| Date of Study Completion (India) |
30/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
15 peer reviewed publications |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diabetes
is a major problem in India with 1 in 12 people affected amounting to 69
million with diabetes currently. Majority
of the studies on how diabetes develops, how patients respond to medications
and the determinants of medical complications that arise are from white
European ancestry populations despite the fact that diabetes in Europeans is
very different to diabetes in Indian-Asians.
There is a need for a large in-depth study of the causes and
consequences of diabetes in India in order to identify patient strata in a
population-specific way. The unit
commands access to two of the most advanced type 2 diabetes management systems
in the world: the Scottish Care Information-Diabetes (SCI-DC), which provides a
sophisticated shared electronic patient record for every individual with type 2
diabetes in Scotland (n=250K) and the Dr
Mohan’s Specialities Diabetes Centres (DMDSC). This unit will integrate
clinical, retinal image and molecular information to achieve personalized
diabetes treatment in India, in particular to provide a low-cost, agile and
sustainable solution for telemedicine outreach to the rural population India.
|