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Status:

RECRUITING

Study of the Effect of Innate on the Inflammatory Response to Endotoxin

Lead Sponsor:

National Institute of Environmental Health Sciences (NIEHS)

Conditions:

Asthma

Atherosclerosis

Eligibility:

All Genders

18-100 years

Brief Summary

Background: \- Innate immunity is the process by which white blood cells and other parts of the immune system sense and respond to potential infections by causing an inflammation. Researchers are int...

Detailed Description

This research study will examine the role of innate immunity on the Inflammatory response of monocytes and macrophages to endotoxin. Approximately 1450 healthy participants aged 18 years and older wil...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Male or female 18 years of age or older
  • Participants must be able to understand and provide written informed consent to participate in the study
  • Participants must be able to travel to the CRU
  • Willing and able to fast after midnight the night prior to their study appointment
  • Healthy participants as defined by the International Red Cross guidelines (Healthy means that an individual feels well and can perform normal activities. If the individual has a chronic condition such as diabetes or high blood pressure, healthy also means that they are being treated and the condition is under control).
  • EXCLUSION CRITERIA:
  • Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 5 days prior to enrollment visit (e.g., Motrin, ibuprofen, naproxen, and Advil)
  • Use of acetaminophen (Tylenol) within 5 days prior to enrollment visit
  • Use of cholesterol lowering drugs (statins) within 30 days prior to enrollment visit (e.g., Zocor, Mevacor, Lipitor, and Crestor)
  • Use of immunosuppressants or other immune-modifying drugs \[e.g., Rituxan, Humira, Enbrel, Cyclosporin (Neoral, Sandimmune, and SangCya), and Azathioprine (Imuran)\], Monoclonal antibodies \[e.g., infliximab (Remicade)\], and corticosteroids (e.g., prednisone, prednisolone and dexamethasone)
  • Current treatment for cancer with chemotherapy or radiation
  • Confirmed or suspected immunosuppressive or immunodeficient condition
  • GI or respiratory Illness within 5 days prior to enrollment visit, including cold or allergies
  • Smoked tobacco, chewed tobacco or used electronic cigarettes within 2 weeks prior to enrollment visit (for participants who provide a urine specimen, this will be defined by urine cotinine \>200 ng/mL at visit)
  • Alcohol consumption greater than 2 standard drinks (1 standard drink contains 15 g of ethanol) per day within the last 24 hours prior to the enrollment visit
  • Body weight \< 50 kg (\<110 lbs)
  • Temperature \> 37.6 C; blood pressure \< 90/50 mm Hg or \> 170/95 mm Hg; pulse rate \< 50 or \>100 beats/minute
  • Pregnant or suspected pregnancy
  • Chronic Kidney Disease
  • The PI may review medication use on a case by case basis and make a medical determination on the participant s eligibility. In these cases, the PI determination will be documented in the participant s chart.

Exclusion

    Key Trial Info

    Start Date :

    July 30 2012

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    725 Patients enrolled

    Trial Details

    Trial ID

    NCT01143480

    Start Date

    July 30 2012

    Last Update

    September 30 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    NIEHS Clinical Research Unit (CRU)

    Research Triangle Park, North Carolina, United States, 27709