Physiological Changes in Adults With Metabolic Syndrome Exposed to Ultrafine Air Particles

Metabolic Syndrome Clinical Trial

— XCON  

Official title:

Physiological Changes in Adults With Metabolic Syndrome Exposed to Concentrated Ultrafine Chapel Hill Air Particles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475968
• Other study ID #: XCON
• Secondary ID: 04-1677
• Status: Completed
• Phase: N/A
• First received: November 14, 2011
• Last updated: November 5, 2013
• Start date: December 2004
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: Environmental Protection Agency (EPA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2013
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Other:
• Ultrafine Air Pollution Particulate Matter
Ultrafine (particle diameter less than 2.5 microns) Air Pollution Particulate Matter, concentrated from the ambient air outside of the Chapel Hill EPA Human Studies Facility
• Filtered Air
Filtered Air

Locations

Country	Name	City	State
United States	EPA Human Studies Facility	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
David Diaz-Sanchez	Environmental Protection Agency (EPA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Vascular Function	Measurement of dilatation of the brachial artery (flow mediated and nitroglycerin mediated); Measurement of vasoconstrictor/vasodialtor, pro-coagulant, or pro-inflammatory mediators into systemic circulation (by ELISA of plasma); Measurement of changes in plasma levels of circulating microparticles and endothelial progenitor cells (as indicators of vascular injury or remodeling)	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	No
Secondary	Changes in heart rate variability	10 minute electrocardiogram recording (measure by Holter ECG) in which the subject has been resting for 20 minutes prior. Collected on a Mortara H12+ 12-Lead ECG Recorder (Mortara Instrument, Inc., Milwaukee, WI). The digitally recorded ECGs were sampled at 180 Hz and all data were stored on flash cards before processing.	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	No