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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  
Variant Bio, USA 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

 


 
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