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CTRI Number  CTRI/2025/07/091265 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 18/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Lipid biomarker studies in stored samples 
Study Design  Other 
Public Title of Study   Blood test that inform the rural population in south India about their unhealthy fat in their body 
Scientific Title of Study   Identifying clinical biomarkers for unfavorable fat distribution among rural population - TREND Study 
Trial Acronym  TREND 
Secondary IDs if Any  
Secondary ID  Identifier 
NIl  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R Guha Pradeepa 
Designation  Head Department of Research Operations and Diabetes Complications 
Affiliation  Madras Diabetes Research Foundation Department of Research Operations and Diabetes Complications 
Address  4 Conran Smith Road
Gopalapuram
Chennai
TAMIL NADU
600086
India 
Phone  09840856063  
Fax    
Email  guhapradeepa@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr R Guha Pradeepa 
Designation  Head Department of Research Operations and Diabetes Complications 
Affiliation  Madras Diabetes Research Foundation Department of Research Operations and Diabetes Camplications 
Address  4 Conran Smith Road
Gopalapuram
Chennai
TAMIL NADU
600086
India 
Phone  09840856063  
Fax    
Email  guhapradeepa@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr R Guha Pradeepa 
Designation  Head Department of Research Operations and Diabetes Complications 
Affiliation  Madras Diabetes Research Foundation Department of Research Operations and Diabetes Complications  
Address  4 Conran Smith Road
Gopalapuram
Chennai
TAMIL NADU
600086
India 
Phone  09840856063  
Fax    
Email  guhapradeepa@gmail.com  
 
Source of Monetary or Material Support  
Queen Mary University of London, Mile End Road London E1 4NS UK  
 
Primary Sponsor  
Name  Queen Mary University of London  
Address  Mile End Road London E1 4NS UK 
Type of Sponsor  Other [University] 
 
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 
DrRMAnjana  Madras Diabetes Research Foundation  Department of Diabetology, 4 Conran Smith Road Gopalapuram Chennai 600086
Chennai
TAMIL NADU 
09940652581

dranjana@drmohans.com 
 
Details of Ethics Committee  
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 
Healthy Human Volunteers  With and without diabetes 
 
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  Participants who have not receive medication for type 2 diabetes
Availability of genotype data
Availability of stored venous blood samples
 
 
ExclusionCriteria 
Details  Individuals with self-reported diabetes 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quantifying the diagnostic accuracy of adiponectin and leptin supports their potential integration into clinical screening tools and enhances our understanding of the biological mechanisms linking adipose tissue distribution to metabolic health  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Polygenic risk score developed for unfavourable fat distribution   1 year 
 
Target Sample Size   Total Sample Size="4732"
Sample Size from India="4732" 
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)   01/10/2025 
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="1"
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  

We aim to understand how the location of fat stored in the body affects people’s chances of developing type 2 diabetes at an early age. Body Mass Index is widely used as a predictor of type 2 diabetes, but it does not tell the whole story. People of Asian Indian ancestry develop type 2 diabetes much younger than people of European ancestry, and they often do so with a healthy BMI. This may be because people of Asian Indian ancestry tend to store fat around their organs rather than under the skin known as unfavorable fat distribution. Therefore, a person may have a healthy BMI, but fat stored around organs such as their liver could still be putting strain on the body and leading to earlier onset of metabolic diseases. Therefore, we are undertaking this project to identify better biomarkers of fat distribution that could be detected in routine blood tests. Furthermore, we hope to identify genetic signatures (polygenic risk scores) for such fat distribution patterns that can help us identify people at risk long before they develop metabolic diseases, and develop more targeted interventions to improve fat distribution patterns. It is also possible that the genetic discoveries will help lead us toward the possibility of develop therapeutics. This, for this study stored blood samples of 4732 adult participants of either sex aged 18 and above years and already have genotype data  who were recruited in a cross-sectional door to door population-based TREND survey called the Telemedicine PRoject for screENing Diabetes and its complications in rural Tamil Nadu  conducted between 2018 and 2021 will be analyzed for serum adiponectin, leptin and insulin levels. The study covered 30 selected villages in Cheyur taluk, situated in Kancheepuram district of Tamil Nadu state in southern India.

 
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