跳至主要内容
临床试验/CTRI/2025/09/095234
CTRI/2025/09/095234尚未招募不适用

Association of environmental factors and heavy metal exposure with glycemic parameters in rural regions of Tamil Nadu

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
2,000
试验地点
1
主要终点
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

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Those who have lived in rural areas for more than 5 years Willing to give informed consent.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: Baseline

次要结局

  • Explore how PM2.5 black carbon impact betacell function insulin resistance oxidative stress lipid peroxidation & their association with diabetes

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr R Guha Pradeepa

Madras Diabetes Research Foundation

研究点 (1)

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