| CTRI Number |
CTRI/2025/09/095234 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impurities and metals in air and the risk of diabetes in villages of Tamil Nadu |
|
Scientific Title of Study
|
Association of environmental factors and heavy metal exposure with glycemic parameters in rural regions of Tamil Nadu |
| 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 R Guha Pradeepa |
| Designation |
Executive Scientific Officer and Head Dept of Research Operations and Diabetes Complications |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No 4 Conran Smith Road Gopalapuram
Chennai
Chennai
TAMIL NADU
600004
India |
| Phone |
09840856063 |
| Fax |
|
| Email |
guhapradeepa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Guha Pradeepa |
| Designation |
Executive Scientific Officer and Head Dept of Research Operations and Diabetes Complications |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No 4 Conran Smith Road Gopalapuram
Chennai
Chennai
TAMIL NADU
600004
India |
| Phone |
09840856063 |
| Fax |
|
| Email |
guhapradeepa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Guha Pradeepa |
| Designation |
Executive Scientific Officer and Head Dept of Research Operations and Diabetes Complications |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No 4 Conran Smith Road Gopalapuram
Chennai
Chennai
TAMIL NADU
600004
India |
| Phone |
09840856063 |
| Fax |
|
| Email |
guhapradeepa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madras Diabetes Research Foundation |
| Sri Ramachandra Institute for Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V Ramalingaswami Bhawan PO Box No. 4911
Ansari Nagar New Delhi 10029 India |
| Type of Sponsor |
Government funding agency |
|
|
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 R Guha Pradeepa |
Madras Diabetes Research Foundation |
Department of Research Operations and Diabetes Complications 4 Conran Smith Road Gopalapuram Chennai 86
Chennai
TAMIL NADU |
09840856063
guhapradeepa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Madras Diabetes Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Type 2 diabetes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Those who have lived in rural areas for more than 5 years
Willing to give informed consent
|
|
| ExclusionCriteria |
| Details |
Pregnant or lactating
Bedridden
Neurological and cognitive impairment
Individuals who have migrated from and to urban areas within 5 years
Temporarily outside the study area during the time of the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To quantify the relationship between air pollutantsPM2.5 and black carbon and glycemic parameters and create a pilot personal exposure profile for toxic metals/inorganic elements, providing evidence on how environmental factors can influence metabolic disorders |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Explore how PM2.5 black carbon impact betacell function insulin resistance oxidative stress lipid peroxidation & their association with diabetes
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
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
|
Air pollution has recently emerged as a novel risk factor for metabolic disorders. Prior research has been largely focused on ambient fine particulate matter PM2.5 a cardio-respiratory and select maternal and child health outcomes among urban populations with limited focus on linkages with diabetes and among rural populations. This study attempts to establish continuous quantitative exposure response relationships between air pollution fine particulate matter and black carbon exposures and glycemic parameters of the rural population by using outdoor and personal exposure monitoring of fine particulate matter and black carbon along with assessments of heavy metals and other pollutants. Further this study is unique to explore the probable mechanism of actions of fine particulate matter and its constituents to glycemic parameters through insulin resistance inflammation oxidative stress and lipid peroxidation. The objective of this study is to estimate the association between air pollutants heavy metals and other inorganic elements and glycemic parameters in the rural adult population of Tamil Nadu in South India. This is a cross-sectional study planned be conducted among 2000 individuals aged 30 to 65 years residing in 10 villages. 200 participants will be selected from each village in two districts of Chengelpet and Kallakurichi of rural Tamil Nadu. Written informed consent will be obtained from all study participants in the local language.An interviewer administered structured questionnaire will be administered to all participants to capture relevant demographic lifestyle personal details medical history information related to household exposure to air pollutants and awareness regarding air pollution. Anthropometric measurements including height weight waist circumference body composition analysis and blood pressure will be measured. A fasting blood sample will be drawn to measure blood sugar HbA1c lipids insulin and other biomarkers. In each participant 24-hour exposure to air pollutants using real-time personal monitors yearlong ambient air data using low-cost devices in one per village and glycemic levels and related biomarkers will be assessed. Every tenth participant that is two hundred participants will undergo additional testing for heavy metals and inorganic elements via personal air quality monitoring and urinary samples. This study will provide critical insights into how air pollutants affect metabolic health in rural India, thereby informing targeted public health interventions and policies.
|