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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04854187
• Other study ID #: IITK/IEC/2020-21/II/31
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: March 25, 2024

Study information

• Verified date: May 2022
• Source: Medstar Health Research Institute
• Contact: Dweep Barbhaya, MBBS
• Phone: 2026044161
• Email: dweepbarbhaya[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 25, 2024
• Est. primary completion date: March 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Hypertension arm

1. Individuals age 18-70 years old with systolic blood pressure between 130-160 mmHg, regardless of medication use

2. Stable hypertension for the past 3 months with no medication changes

3. No planned medication changes for the duration of the study

4. Exposure to outdoor air pollution above a certain threshold (pollution levels will be measured using AirVeda devices)

5. Individuals who sleep in a closed space (such as a bedroom) for minimum of 6 hours/daily.

6. Use of gas (LPG)/electricity for cooking purposes

Diabetes arm

1. Individuals age 18-70 years old with fasting blood glucose between 126-180 mg/dL, regardless of medication use

2. Stable diabetes for the past 3 months with no medication changes

3. No planned medication changes for the duration of the study

4. Exposure to outdoor air pollution above a certain threshold (pollution levels will be measured using AirVeda devices)

5. Individuals who sleep in a closed space (such as a bedroom) for minimum of 6 hours/daily.

6. Use of gas (LPG)/electricity for cooking purposes

Exclusion Criteria:

1. Unwilling to participate

2. Unstable blood pressure and/or blood glucose level requiring frequent medication changes

3. Individual suffering from a physical or mental illness that precludes active study participation

4. Current smoker

5. Planned vacation/absence from the study site

6. Patients with life expectancy < 12 months

7. Pregnant patients

Related Conditions & MeSH terms

• Diabetes Mellitus
• HTN
• Hypertension
• Pollution; Exposure

Intervention

Device:
• N95 Mask/Indoor air purifier: Including sham
Participants will be using indoor air purifier and N95 mask (control arm with sham filters). The effect will be studied on blood pressure and blood glucose levels.

Locations

Country	Name	City	State
India	Sehat Charitable trust	Dalkhola	West Bengal

Sponsors (2)

Lead Sponsor	Collaborator
Medstar Health Research Institute	Indian Institute of Technology Kanpur

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change in systolic blood pressure for people with hypertension using air purifier and facemask	We will monitor blood pressure at week 0,2,4 of both intervention and control period. Outcome would be measured as difference in the mean systolic blood pressure between both arms.	4 weeks
Primary	Absolute change in fasting blood glucose for people with diabetes using air purifier and facemask	We will monitor fasting blood glucose at week 0,2,4 of both intervention and control period. Outcome would be measured as difference in the mean systolic blood pressure between both arms.	4 weeks