Metabolic SyndromeXCONNCT01475968

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

A study testing Ultrafine Air Pollution Particulate Matter and Filtered Air in people with Metabolic Syndrome, run by David Diaz-Sanchez at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 to 70 years
Conditions the study is for: Metabolic Syndrome
What is being tested?: Ultrafine Air Pollution Particulate Matter and Filtered Air
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteUnited States
Study dates: Dec 2004to Oct 2013
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

EPA Human Studies Facility
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

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

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.

Conditions: Metabolic Syndrome
Being tested: Ultrafine Air Pollution Particulate Matter, Filtered Air
Medical subject headings: Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ultrafine Air Pollution Particulate MatterOther
Also called ultrafine particulate matter, concentrated ambient particulates (CAPS)
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 AirOther
Also called clean air
Filtered Air

Study groups in NCT01475968
Study group	Role	What they receive
Ultrafine Air Pollution Particulate Matter	Active comparator	<2.5 microns concentrated from outside ambient air Receives: Other: Ultrafine Air Pollution Particulate Matter
Filtered Air	Sham comparator	Filtered Air Receives: Other: Filtered Air

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Vascular Function
1. Measurement of dilatation of the brachial artery (flow mediated and nitroglycerin mediated)
2. Measurement of vasoconstrictor/vasodialtor, pro-coagulant, or pro-inflammatory mediators into systemic circulation (by ELISA of plasma)
3. Measurement of changes in plasma levels of circulating microparticles and endothelial progenitor cells (as indicators of vascular injury or remodeling)
Measured: 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 (1)

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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2004Oct 2013

First posted22 Nov 2011 (estimated)
Study startDec 2004
Primary completionJun 2011
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01475968
Sponsor's protocol ID: XCON
Other IDs: 04-1677
Acronym: XCON
Status last verified: Nov 2013
First submitted: 14 Nov 2011
Last updated: 7 Nov 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metabolic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physiological Changes in Adults With Metabolic Syndrome Exposed to Concentrated Ultrafine Chapel Hill Air Particles
ClinicalTrials.gov ID: NCT01475968
Acronym / sponsor ID: XCON / XCON
Conditions: Metabolic Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: David Diaz-SanchezUS federal agency
Collaborators: Environmental Protection Agency (EPA)
Study start: Dec 2004
Primary completion: Jun 2011 (actual)
Study completion: Oct 2013 (actual)
First posted: 22 Nov 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Ultrafine Air Pollution Particulate Matter	Active comparator	Other: Ultrafine Air Pollution Particulate Matter<2.5 microns concentrated from outside ambient air
Filtered Air	Sham comparator	Other: Filtered AirFiltered Air

Who may qualify

Ages: 25 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age between 25-70 years old
Metabolic syndrome as defined by the participant having at least three of the following criteria:
Normal resting electrocardiograph (ECG).

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ultrafine Air Pollution Particulate MatterAlso: ultrafine particulate matter, concentrated ambient particulates (CAPS)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	Other	Ultrafine Air Pollution Particulate Matter
Filtered AirAlso: clean airFiltered Air	Other	Filtered Air

Primary outcome

Changes in Vascular Function
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
1. Measurement of dilatation of the brachial artery (flow mediated and nitroglycerin mediated) 2. Measurement of vasoconstrictor/vasodialtor, pro-coagulant, or pro-inflammatory mediators into systemic circulation (by ELISA of plasma) 3. Measurement of changes in plasma levels of circulating microparticles and endothelial progenitor cells (as indicators of vascular injury or remodeling)

1 secondary outcome

Changes in heart rate variability
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2013.

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RecruitingObservational study
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Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert B Devlin, PhD principal investigator

US EPA

Candice B Smith, PhD principal investigator

US EPA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ultrafine Air Pollution Particulate Matter and Filtered Air in people with Metabolic Syndrome, run by David Diaz-Sanchez at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Vascular Function (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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01475968.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2013.