Effect of Air Pollution Mitigation Strategies on Heart and diabetes endpoints in India

Not Applicable

Conditions: Health Condition 1: null- Early diabetes and Metabolic syndrome patientsHealth Condition 2: J22- Unspecified acute lower respiratory infection

Registration Number: CTRI/2018/02/012162

Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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 <7.5, on no medications or only one drug that consists of either metformin, sulfonylurea, pioglitazone, SGLT-2 inhibitor or a DPP4-inhibitor, and on a stable dose for at least 4 months.

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 <1.03 mmol/L in men and <1.3 mmol/L in women; TGs >=1.7 mmol/L; FPG >=5.6 mmol/L; BP >=130/85 mmHg).

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.