Health Condition 1: null- Early diabetes and Metabolic syndrome patients Health Condition 2: J22- Unspecified acute lower respiratory infection
Conditions
Interventions
Intervention1: air purifier(APHF) and dust respirator face masks(DR): Air purifier with HEPA filter (APHF) (3M) and an 8812 dust respirator (DR) (3M) Sham modal of the above mansion equipment would be
Sponsors
Johns Hopkins Bloomberg School of Public Health
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or Female age 40-60 years of age, able to provide informed consent and willingness to complete the study protocol and measurement procedures AND 2.Non-smoker of any type (cigarette, bidi, cigar) during past year (100% abstinence as per self report) and living in a non-smoking household (no person living in the household smoking at home) AND 3.Living in a household with any outside Windows that can be fully closed to prevent outside air penetration indoors (and thus preventing the efficacy of the air purifier with HEPA filter) with the household AND 4.Spend at least four hours per day outside the house AND 5.Early Type II diabetes with HbA1c OR International Diabetes Federation criteria for metabolic syndrome for Asians defined as either impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) with additional 2 components [(waist circumference >80 cm in females or >=90 cm in males) and 2 of the following (HDL =1.7 mmol/L; FPG >=5.6 mmol/L; BP >=130/85 mmHg).
Exclusion criteria
Exclusion criteria: 1.Inability for mental or physical reasons to understand and comply with the informed consent process and/or the study protocol procedures. 2.Obesity with arm circumference >18 inches preventing accurate BP determination during ABPM monitoring. 3.Diagnosis of any established cardiovascular disease including prior myocardial infarct, any revascularization, coronary atherosclerosis, peripheral atherosclerosis, carotid disease, prior TIA or stroke, heart failure of any type, prior or active angina, aneurysmal disease. 4.Significant arrhythmia including ventricular tachycardia, frequent PVCs, atrial fibrillation. 5.Type I diabetes mellitus and/or use of insulin. 6.Past diagnosis of advanced CKD (stage Ill or greater) or chronic liver disease. 7. Past diagnosis of asthma or any lung disease (ie COPD). Regular usage of any inhaler (ie beta-agonist, steroids). 8.Past diagnosis of systemic inflammatory disease (rheumatological diseases such as RA, SLE, vasculitis) or inflammatory bowel disease. 9. Abnormal urinary cotinine consistent with active smoking at screening visit. 10. Uncontrolled stage II hypertension (SBP >160 and/or DBP >100 mmHg) at screening that requires urgent treatment. 11. Past diagnosis of sleep apnea either untreated or treated with CPA. 12. Use of any anti-hypertensive medication (e.g., beta blocker, ACE inhibitor). 13. Treated hyperlipidemia or usage of any lipid-lowering medication (e.g., statin). 14. Daily use of aspirin for cardiac prevention. 15. Anticoagulation use of any type (warfarin, direct anti-thrombotic). 16. History of malignancy including leukemia and lymphoma (but not basal cell skin cancer, cured squamous cell cancer and localized prostate cancer) AND/OR any severe, life-threatening disease AND/OR history of drug abuse within the last 2 years. 17. Regular heavy alcohol intake of >14 drinks per week or consumption of more than 6 or more drinks on one or more occasions per week. 18. Regular use of any over-the-counter drug, recreational medication including stimulants (amphetamines) and/or complimentary or herbal therapy that might impact study outcomes including BP and insulin sensitivity, per investigator discretion. This includes regular use ( >twice per week) of anti-oxidants (Vitamin C, E); fish oil supplements ( >1000 mg/d) and NSAID. 19. In women of childbearing age: pregnancy, non-use of approved method of birth control, intent to get pregnant during the study period. 20. Other medical or psychosocial conditions or life circumstances that may put the subject at increased risk of participation or jeopardize the scientific integrity of the study, as determined by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Personal exposure monitoring of PM2.5: 2. BP will be measured each morning. Measurements will be made in the home by a study worker using a BP cuff. 3. Homeostatic Model Assessment of Insulin Resistance and glucose tolerance: Blood (10ml) will be collected on the morning of days 6, 13, and 20 after an 8h fast for HOMA-IR, which is a validated measure of insulin sensitivity 4. SGRQ and RQLQ at baseline during recruitment and day 6, 13 and 20. Timepoint: days 6, 13, 20, and 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured via ECG for 10 minutes while the participant is in a supine position. Aortic Hemodynamics and Arterial Compliance. Plasma cytokines: C-reactive protein cortisol. Participants will wear an APB cuff for 24h and measure BP every 30 minutes during waking hours and every 2 hours during sleeping hours Urinary mercapturic acid conjugates of benzene acrolein will be measured via HPLC. Changes in DNA methylation as an indicator of epigenetic reprogramming using white blood cells. Timepoint: days 6, 13, and 20 | — |
Countries
India
Contacts
Public ContactDr Mradul Kumar Daga
Maulana Azad Medical College
Outcome results
None listed