Status:
COMPLETED
The Effect of Personal Protective Aids on Hypertension and Diabetes in People Exposed to High Levels of Air Pollution
Lead Sponsor:
Medstar Health Research Institute
Collaborating Sponsors:
Indian Institute of Technology Kanpur
Conditions:
Pollution; Exposure
HTN
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 I...
Detailed 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...
Eligibility Criteria
Inclusion
- Hypertension arm
- Individuals age 18-70 years old with systolic blood pressure between 130-160 mmHg, regardless of medication use
- Stable hypertension for the past 3 months with no medication changes
- No planned medication changes for the duration of the study
- Exposure to outdoor air pollution above a certain threshold (pollution levels will be measured using AirVeda devices)
- Individuals who sleep in a closed space (such as a bedroom) for minimum of 6 hours/daily.
- Use of gas (LPG)/electricity for cooking purposes
- Diabetes arm
- Individuals age 18-70 years old with fasting blood glucose between 126-180 mg/dL, regardless of medication use
- Stable diabetes for the past 3 months with no medication changes
- No planned medication changes for the duration of the study
- Exposure to outdoor air pollution above a certain threshold (pollution levels will be measured using AirVeda devices)
- Individuals who sleep in a closed space (such as a bedroom) for minimum of 6 hours/daily.
- Use of gas (LPG)/electricity for cooking purposes
Exclusion
- Unwilling to participate
- Unstable blood pressure and/or blood glucose level requiring frequent medication changes
- Individual suffering from a physical or mental illness that precludes active study participation
- Current smoker
- Planned vacation/absence from the study site
- Patients with life expectancy \< 12 months
- Pregnant patients
Key Trial Info
Start Date :
March 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2024
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04854187
Start Date
March 25 2021
End Date
October 17 2024
Last Update
October 22 2024
Active Locations (1)
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1
Sehat Charitable trust
Dalkhola, West Bengal, India, 733201