| CTRI Number |
CTRI/2025/08/093034 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
30/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Diabetes in Thin People through genetic studies in India |
|
Scientific Title of Study
|
Genomic insights into lean diabetes and metabolic conditions in India |
| 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 Ranjit Mohan Anjana |
| 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 |
43968888 |
| Fax |
|
| Email |
dranjana@drmohans.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ranjit Mohan Anjana |
| 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 |
43968888 |
| Fax |
|
| Email |
dranjana@drmohans.com |
|
Details of Contact Person Public Query
|
| Name |
Dr R Guha Pradeepa |
| Designation |
Executive Scientific Officer, and Head Department of Research Operations and diabetes complications |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Madras Diabetes Research Foundation
No 4 Conran Smith Road
Gopalapuram
Chennai
Chennai TAMIL NADU 600086 India |
| Phone |
09840856063 |
| Fax |
|
| Email |
guhapradeepa@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Variant Bio, USA |
| Address |
188 E Blaine St, Suite 126, Seattle, Washington 98102, USA |
| Type of Sponsor |
Other [Biotech company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anjana Ranjit Mohan |
Madras Diabetes Research Foundation |
Department of Diabetology, 4 Conran Smith Road
Gopalapuram Chennai 600086 Chennai TAMIL NADU |
43968888
dranjana@drmohans.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Madras Diabetes Research Foundation Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 Diabetes and Lean individuals aged 18 years or above, clinically diagnosed with type 2 diabetes, and a body mass index more than 16 and less than 23
Type 2 Diabetes and Non lean individuals aged 18 years or above clinically diagnosed with type 2 diabetes and a body mass index greater than or equal to 23
Non diabetes individuals aged 18 years or above have a body mass index more than 16 and have never been clinically diagnosed with diabetes While they should be generally healthy individuals and may have been diagnosed with other non severe conditions that are not diabetes |
|
| ExclusionCriteria |
| Details |
Refuse or are unable to understand or give consent
Have a condition(s) that may make participation unsafe
Are under guardianship or trusteeship
Are pregnant or breastfeeding
Have a clinical diagnosis of type 1 diabetes, MODY, or LADA (confirmatory tests not required, only exclude if clinical diagnosis has already been made)
Are unable to return for biological sampling (if necessary)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will be a comprehensive map of genetic variants associated with the risk of lean and non lean diabetes and comorbidities in an Indian population |
Three years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will be to map genetic variants to quantitative molecular traits such as biomarkers, gene expression, gene splicing, proteins, and metabolites which will allow us to translate our genetic findings to a molecular mechanism associated with disease susceptibility or progression |
Three years |
|
|
Target Sample Size
|
Total Sample Size="10000" Sample Size from India="10000"
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)
|
01/12/2025 |
| 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="3" 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
|
Across India, there has been a documented increase in the
prevalence of metabolic disease including diabetes dyslipidemia and
hypertension particularly in urban regions. A subset of these cases falls into a category known as lean diabetes in which diabetic
patients present without concurrent obesity. In India in particular lean diabetes is on the rise, accounting
for up to 50 percent of all diabetes cases in certain regions. While there are
numerous treatments for typical type 2 diabetes many patients do not achieve
full remission on these medications, even with significant weight loss. This may be a product of their specific presentation or
duration of diabetes that is decreased beta cell function and underlying
genetic factors. Given this there is a pressing need to identify novel diabetes
therapeutic targets which influence disease beyond obesity-related risk factors
and may present an additional option for patients to achieve diabetic remission.
While both diabetes generally and lean diabetes specifically, are known to be
highly prevalent in India, few studies have explored the underlying cause of
this heightened prevalence in detail. We hypothesize that lean diabetes in
India has a distinct genetic architecture from non-lean diabetes both of which
may be driven in part by population-enriched genetic variation which is rare or
absent in other global diabetes cohorts. Through the approach detailed here we
expect to uncover novel genes and genomic mechanisms influencing diabetes and
related traits in India. Thus the purpose of this study is to map the genetic
architecture and molecular signatures of lean with a BMI less than 23 and non lean
with a BMI greater than or equal to 23 with type 2 diabetes and related
metabolic traits in India. To do so we plan to recruit up to 10000
participants total, with up to 3500 participants who are diagnosed with lean
diabetes up to 3500 participants diagnosed with non lean diabetes and up to 3000
individuals who do not have type 2 diabetes. Samples collected from these
participants will be used to generate whole genome sequencing data along with
comprehensive physiological and molecular phenotyping and health history. This
phenotypic data paired with genetics will allow us to not only explore variants
associated with disease risk, but also understand the mechanism by which they influence
disease traits.
|