Association of environmental factors and heavy metal exposure with glycemic parameters in rural regions of Tamil Nadu
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 2,000
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 30.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Those who have lived in rural areas for more than 5 years Willing to give informed consent.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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
Time Frame: Baseline
Secondary Outcomes
- Explore how PM2.5 black carbon impact betacell function insulin resistance oxidative stress lipid peroxidation & their association with diabetes
Investigators
Dr R Guha Pradeepa
Madras Diabetes Research Foundation