| CTRI Number |
CTRI/2025/03/083731 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Genetic study of type 2 diabetes and prediabetes in South Asians |
|
Scientific Title of Study
|
Molecular mechanisms in T2D, prediabetes phenotypes and vascular disease in South Asians |
| Trial Acronym |
nil |
|
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 |
Chairman |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Room No G15
Department of Diabetology
Division of Clinical Studies
4 Conran smith road
Gopalapuram
Chennai
Chennai
TAMIL NADU
600086
India |
| Phone |
9840097370 |
| Fax |
|
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Radha Venkatesan |
| Designation |
Executive Scientific Officer and Head |
| Affiliation |
Madras Diabetes Research Foundation India |
| Address |
Dept. of Molecular Genetics Madras Diabetes Research Foundation
20 Golden Jubilee Biotech Park for Women Society SIPCOT Siruseri
Chennai
TAMIL NADU
603103
India |
| Phone |
09840106815 |
| Fax |
|
| Email |
radharv@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Radha Venkatesan |
| Designation |
Executive Scientific Officer and Head |
| Affiliation |
Madras Diabetes Research Foundation India |
| Address |
Dept. of Molecular Genetics Madras Diabetes Research Foundation
20 Golden Jubilee Biotech Park for Women Society SIPCOT Siruseri
Chennai
TAMIL NADU
603103
India |
| Phone |
09840106815 |
| Fax |
|
| Email |
radharv@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Novo Nordisk Foundation
Address
Tuborg Havnevej 19
Hellerup
Country Denmark
Pincode 2900 |
|
|
Primary Sponsor
|
| Name |
Novo Nordisk Foundation |
| Address |
Tuborg Havnevej 19, 2900 Hellerup, Denmark |
| Type of Sponsor |
Other [Danish enterprise foundation that supports scientific, humanitarian and social causes] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nikhil Tandon |
All India Institute of Medical Sciences (AIIMS) |
Room No. 312, Department of Endocrinology and Metabolism, 3rd Floor Biotechnology Block, AIIMS
Ansari Nagar
New Delhi 110029
New Delhi
DELHI |
9818211663
nikhil_tandon@hotmail.com |
| Prof Dorairaj Prabhakaran |
Centre for Chronic Disease Control (CCDC) |
C1/52, 2nd Floor,
Safdarjung Development Area,
New Delhi, India – 110016
New Delhi
DELHI |
9810118696
dprabhakaran@ccdcindia.org |
| Dr V Mohan |
Madras Diabetes Research Foundation (MDRF) |
Room No G15,
Department of Diabetology,
Division of Clinical Studies,
4, Conran Smith Road, Gopalapuram, Chennai
Chennai
TAMIL NADU |
9840097370
drmohans@diabetes.ind.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Madras Diabetes Research Foundation |
Approved |
| Institutional Ethics Committee of Madras Diabetes Research Foundation |
Approved |
| Institutional Ethics Committee of Madras Diabetes Research Foundation |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals with normal glucose tolearance and on no antidiabetic medication |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Group 1: Normal Glucose Tolerant individuals (NGT; n=6793)
Individuals with fasting plasma glucose less than 100mg/dl and 2h-PG less than 140mg/dl or HbA1c less than or equal to 5.7% and on no antidiabetic medication.
Group 2: Individuals with prediabetes (n=1782)
Fasting plasma glucose between 100-125 mg/dL or 2h-PG between 140-199 mg/dL or HbA1c gretaer than 5.7-6.4% and on no antidiabetic medication.
Group 3: Individuals with type 2 diabetes (T2D; n=2561)
Diagnosis of T2D is based on the ADA criteria. Fasting plasma glucose greater than or equal to 126mg/dl or 2h-PG greater than or equal to200mg/dl or HbA1c greater than 6.4%.
|
|
| ExclusionCriteria |
| Details |
Participants with type 1 diabetes will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be the identification of genetic variants associated with glycemic traits and development of polygenic prediction models for drug response traits for type 2 diabetes. |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="11136"
Sample Size from India="11136"
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)
|
01/05/2025 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This project is based on banked biospecimens (by adding whole genome sequencing (WGS) measurements) and annually collected data from the ongoing NIH-funded cohort study, Precision-CARRS (P-CARRS; P01HL154996; 1R01AG089759). P-CARRS is a representative population-based longitudinal study (initiated in 2010) of socio-demographically diverse adults aged 20 and older living in Delhi and Chennai, India (total=21,864; biospecimens banked for n: 19,278)). P-CARRS has an available and ongoing collection of sociodemographic, behavioral (objectively measured activity, sleep, and stress), environmental (pollutants at street-geocode level), cardiometabolic phenotyping data (risk factors, and imaging of vessels and retina, myocardium, and related organs), and multimodal cognitive (neuropsychological examination, neuroimaging, and blood biomarkers). There is no new recruitment of participants. We are only using the stored biospecimens from P-CARRS cohort in India for DNA isolation and whole genome sequencing. |