| 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
|
|
|
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
|
|
|
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. |