The Effect of Personal Protective Aids on Hypertension and Diabetes in People Exposed to High Levels of Air Pollution

Diabetes Mellitus Clinical Trial

Official title: The Effect of Personal Protective Aids on Hypertension and Diabetes in People Exposed to High Levels of Air Pollution

Status Recruiting

Clinical Trial Summary

This is a randomized controlled trial to evaluate personal protective aids (air purifier and N95) as a therapeutic measure in people with hypertension and diabetes exposed to high levels of PM2.5 in India.

Clinical Trial Description

Air pollution is the largest environmental cause of disease and premature death in the world today, disproportionally affecting low- and middle-income countries (LMICs) such as India. Numerous studies have shown that exposure to particulate matter <2.5 µm (PM2.5) can contribute to cardiovascular disease and mortality, which is partially attributable to the development of cardiometabolic conditions such as hypertension and diabetes. We hypothesize that the use of personal protective aids (home air-purifier and N-95 mask) can decrease systolic blood pressure (SBP) in people with hypertension and decrease fasting blood glucose (FBG) in those with diabetes.

This is a prospective randomized cross-over study in Dalkhola, India- an area of high ambient PM2.5 levels. Participants between 18 and 70 years of age with hypertension (n=130) and diabetes (n=33) will be invited to participate in the study. They will be randomized to either an intervention or control arm for 4 weeks, after which they will cross over to the other arm following a 2-week washout period. The intervention period will consist of using an indoor air-purifier at night and an N-95 mask when outdoors. Control period will involve using an identical air purifier and facemask, with the filter removed (sham filtration). Participants and outcome assessors will be blinded.

The primary outcome of the study is the absolute reduction in SBP among people with hypertension and absolute reduction in FBG among people with diabetes.

This is the first randomized controlled trial to evaluate personal protective aids as a therapeutic measure in people with hypertension and diabetes exposed to high levels of PM2.5. Given the high burden of air pollution in LMICs, there is an urgent need for adaptation measures targeting people at high risk for mortality from this exposure. The results of our study will demonstrate if personal protective aids can be a viable adaptation measure for people living with hypertension and diabetes in areas with a high burden of air pollution. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• HTN
• Hypertension
• Pollution; Exposure

• NCT number: NCT04854187
• Study type: Interventional
• Source: Medstar Health Research Institute
• Contact: Dweep Barbhaya, MBBS
• Phone: 2026044161
• Email: dweepbarbhaya@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2021
• Completion date: March 25, 2024