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

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ultrafine Air Pollution Particulate Matter

Filtered Air

About this trial

This is an interventional basic science trial for Metabolic Syndrome

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

EPA Human Studies Facility

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Ultrafine Air Pollution Particulate Matter

Filtered Air

Arm Description

<2.5 microns concentrated from outside ambient air

Filtered Air

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01475968

First Posted

November 14, 2011

Last Updated

November 5, 2013

Sponsor

David Diaz-Sanchez

Collaborators

Environmental Protection Agency (EPA)

1. Study Identification

Unique Protocol Identification Number

NCT01475968

Brief Title

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

Acronym

XCON

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

December 2004 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

David Diaz-Sanchez

Collaborators

Environmental Protection Agency (EPA)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ultrafine Air Pollution Particulate Matter

Arm Type

Active Comparator

Arm Description

<2.5 microns concentrated from outside ambient air

Arm Title

Filtered Air

Arm Type

Sham Comparator

Arm Description

Filtered Air

Intervention Type

Other

Intervention Name(s)

Ultrafine Air Pollution Particulate Matter

Other Intervention Name(s)

ultrafine particulate matter, concentrated ambient particulates (CAPS)

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Filtered Air

Other Intervention Name(s)

clean air

Intervention Description

Filtered Air

Primary Outcome Measure Information:

Title

Changes in Vascular Function

Description

Time Frame

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 Outcome Measure Information:

Title

Changes in heart rate variability

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert B Devlin, PhD

Organizational Affiliation

US EPA

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Candice B Smith, PhD

Organizational Affiliation

US EPA

Official's Role

Principal Investigator

Facility Information:

Facility Name

EPA Human Studies Facility

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

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

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