Clinical trial NCT01475968: Physiological Changes in Adults With Metabolic Syndrome Exposed to Ultrafine Air Particles
Official title: Physiological Changes in Adults With Metabolic Syndrome Exposed to Concentrated Ultrafine Chapel Hill Air Particles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Environmental Protection Agency (EPA)
Sponsor class: FED
Collaborators: name: Environmental Protection Agency (EPA)
First posted: 2011-11-22
Enrollment: 48
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 or medical intervention these patients are at considerable risk for developing diabetes and cardiovascular disease. Subjects (25-70) were exposed to both UF PM and filtered air for 2hr (at least 2 week interval), physiologic endpoints were measure pre-, post-, and 20hr post-exposure. Our hypothesis is that PM exposure in this population will result in changes in vascular and endothelial response as assessed by flow-mediated dilatation of the brachial artery and various heart rate variability and blood endpoints. This study and similar studies of susceptible populations are needed to provide the EPA with information regarding the health risks associated with ambient levels of UF PM.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Changes in Vascular Function
timeFrame: change from baseline 0 hr after exposure, and change from baseline 20 hr after exposure. There will be at leat 2 weeks between the exposures
Secondary outcomes:
measure: Changes in heart rate variability
timeFrame: change from baseline 0 hr after exposure, and change from baseline 20 hr after exposure. There will be at leat 2 weeks between the exposures
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: EPA Human Studies Facility
state: North Carolina
Study officials:
affiliation: US EPA
name: Robert B Devlin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: US EPA
name: Candice B Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: