Status:
COMPLETED
Physiological Changes in Adults With Metabolic Syndrome Exposed to Ultrafine Air Particles
Lead Sponsor:
David Diaz-Sanchez
Collaborating Sponsors:
Environmental Protection Agency (EPA)
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
25-70 years
Phase:
NA
Brief Summary
The purpose of this study is to examine the acute health effects of concentrated ambient ultrafine (UF) particulate matter (PM) exposure in patients with metabolic syndrome. Without lifestyle changes ...
Eligibility Criteria
Inclusion
- Age between 25-70 years old
- Metabolic syndrome as defined by the participant having at least three of the following criteria:
- Abdominal obesity: Men waist circumference \>102 cm (\>40 in) Women waist circumference \>88 cm (\>35 in)
- Triglycerides: ≥150 mg/dL
- HDL cholesterol: Men \<40 mg/dL and Women \<50 mg/dL
- Blood pressure: ≥130/≥85 mmHg OR have a history of high blood pressure requiring medication
- Fasting glucose: ≥100 mg/dL and ≤126 mg/dL
- Normal resting electrocardiograph (ECG).
Exclusion
- Current smoker or smoking history within 3 months of study (defined as more than one pack of cigarettes in the past 3 months).
- Oxygen saturation below 95% at the time of physical exam.
- Blood pressure ≥160/≥100 mmHg
- Fasting blood glucose \>126 mg/dl
- Hypersensitivity to nitroglycerin or other nitrates
- Any chronic medical condition including active pulmonary disease, cardiovascular disease (coronary artery disease, heart failure, rhythm disturbances, etc.), neurological disease, liver disease, kidney disease, muscular disease, diabetes, other endocrine disease, hematologic/lymphatic disease, immune deficiency or autoimmune disease.
- Medications specifically prohibited include nitrates or other vasodilators (exception here includes erectile dysfunction medications if the participant agrees to refrain for 96 hours prior to study), anti-arrhythmics, physician prescribed anti-inflammatory agents, physician prescribed antioxidants, insulin and other medications for the treatment of diabetes. Participants must refrain from all over-the-counter anti-inflammatory agents, including aspirin, ibuprofen, and naproxen, and anti-oxidants for a period of one week prior to exposure. Low dose aspirin and statin regimens are acceptable. Medications not specifically mentioned here may be reviewed by the investigators prior to a participant's inclusion in the study. Additionally, medication regimens must remain constant during the study.
- Hepatitis B carriers
- Skin diseases or sensitivity precluding the use of ECG electrodes
- Active cancer, history of cancer within the last 5 years, untreated cancer. Potential participants may have a history of mild, treated skin cancer provided the condition does not interfere with ECG electrode placement.
- No exposure will be conducted within 4 weeks of a respiratory tract infection.
- History of serve migraines
- Pregnant women or nursing mothers
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01475968
Start Date
December 1 2004
End Date
October 1 2013
Last Update
November 7 2013
Active Locations (1)
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1
EPA Human Studies Facility
Chapel Hill, North Carolina, United States, 27599