Effects of Systemically Administered Hydrocortisone on the Immune System in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 9/5/2018 |
| Start Date: | January 21, 2011 |
| End Date: | August 30, 2018 |
Effects of Systemically Administered Hydrocortisone on the Human Immunome in Healthy Volunteers
Background:
- Corticosteroids have been used to treat inflammation and immune system diseases for
decades. However, despite their widespread use, there is little information on the specifics
of how corticosteroids affect the immune system in humans. The Center for Human Immunology,
Autoimmunity, and Inflammatory Diseases is interested in studying how the steroid hormone
hydrocortisone affects the immune system in healthy volunteers, and in doing so to understand
how hydrocortisone given at different doses works in treating many immune and inflammatory
conditions.
Objectives:
- To evaluate the effects of hydrocortisone on the immune and inflammatory responses of
healthy volunteers over the short and intermediate term (up to 28 days after administration).
Eligibility:
- Healthy volunteers at least 18 years of age.
Design:
- Participants will be screened with a full medical history and physical examination, and
blood and urine tests. At this visit, participants will be separated into two groups,
with each group scheduled to receive a different amount of hydrocortisone during the
study visit.
- One week before the study visit, participants will provide a blood sample for baseline
testing.
- Participants will be admitted for a 24-hour inpatient stay that will involve frequent
blood draws. Between blood draws, participants will be able to work, watch TV, walk
around, and so on, and will be provided with regular meals.
- Blood will be drawn 1 hour before the infusion of hydrocortisone. Participants will be
divided into two further sets of groups with different blood draw schedules:
- Groups 1 (lower dose) and 2 (higher dose) will have blood draws 1, 4, 8, 12, and 24
hours after the hydrocortisone infusion.
- Groups 3 (lower dose) and 4 (higher dose) will have multiple blood draws over 24 hours,
with timing based on data from the previous groups blood test results.
- Participants will provide additional blood samples 7 and 28 days after the in-patient
visit....
- Corticosteroids have been used to treat inflammation and immune system diseases for
decades. However, despite their widespread use, there is little information on the specifics
of how corticosteroids affect the immune system in humans. The Center for Human Immunology,
Autoimmunity, and Inflammatory Diseases is interested in studying how the steroid hormone
hydrocortisone affects the immune system in healthy volunteers, and in doing so to understand
how hydrocortisone given at different doses works in treating many immune and inflammatory
conditions.
Objectives:
- To evaluate the effects of hydrocortisone on the immune and inflammatory responses of
healthy volunteers over the short and intermediate term (up to 28 days after administration).
Eligibility:
- Healthy volunteers at least 18 years of age.
Design:
- Participants will be screened with a full medical history and physical examination, and
blood and urine tests. At this visit, participants will be separated into two groups,
with each group scheduled to receive a different amount of hydrocortisone during the
study visit.
- One week before the study visit, participants will provide a blood sample for baseline
testing.
- Participants will be admitted for a 24-hour inpatient stay that will involve frequent
blood draws. Between blood draws, participants will be able to work, watch TV, walk
around, and so on, and will be provided with regular meals.
- Blood will be drawn 1 hour before the infusion of hydrocortisone. Participants will be
divided into two further sets of groups with different blood draw schedules:
- Groups 1 (lower dose) and 2 (higher dose) will have blood draws 1, 4, 8, 12, and 24
hours after the hydrocortisone infusion.
- Groups 3 (lower dose) and 4 (higher dose) will have multiple blood draws over 24 hours,
with timing based on data from the previous groups blood test results.
- Participants will provide additional blood samples 7 and 28 days after the in-patient
visit....
Corticosteroids have been in widespread therapeutic use as anti-inflammatory and
immunomodulatory agents for decades, and there is a wealth of information on their
immunosuppressive effects in animals and in human cells cultured in vitro. However, despite
their ubiquitous clinical use, there is a paucity of information on the effects of
corticosteroids administered to humans systemically, and no previous study has examined their
effects on the human immunome.
Therefore the Center for Human Immunology, Autoimmunity, and Inflammatory Diseases proposes
this protocol designed to obtain blood from healthy adult subjects at baseline, and then at
various time points after administration of 250 mg and 50 mg of intravenous hydrocortisone.
These samples will be used to perform a comprehensive and detailed analysis of the immune
system in response to corticosteroid administration. To our knowledge, this protocol will be
the first study to characterize the human cellular and molecular immune system parameters, or
immunome, in healthy adult subjects after administration of corticosteroids. This information
may be useful in understanding the mechanistic effects of this commonly prescribed class of
medications in humans.
The primary objective is to perform laboratory studies to characterize the immune response in
healthy adult volunteers after administration of moderate (250 mg) and low (50 mg) doses of
the glucocorticoid hydrocortisone. Primary endpoint is the results of the research laboratory
assessments. As samples will be stored indefinitely, the time frame for primary endpoint is
indefinite.
immunomodulatory agents for decades, and there is a wealth of information on their
immunosuppressive effects in animals and in human cells cultured in vitro. However, despite
their ubiquitous clinical use, there is a paucity of information on the effects of
corticosteroids administered to humans systemically, and no previous study has examined their
effects on the human immunome.
Therefore the Center for Human Immunology, Autoimmunity, and Inflammatory Diseases proposes
this protocol designed to obtain blood from healthy adult subjects at baseline, and then at
various time points after administration of 250 mg and 50 mg of intravenous hydrocortisone.
These samples will be used to perform a comprehensive and detailed analysis of the immune
system in response to corticosteroid administration. To our knowledge, this protocol will be
the first study to characterize the human cellular and molecular immune system parameters, or
immunome, in healthy adult subjects after administration of corticosteroids. This information
may be useful in understanding the mechanistic effects of this commonly prescribed class of
medications in humans.
The primary objective is to perform laboratory studies to characterize the immune response in
healthy adult volunteers after administration of moderate (250 mg) and low (50 mg) doses of
the glucocorticoid hydrocortisone. Primary endpoint is the results of the research laboratory
assessments. As samples will be stored indefinitely, the time frame for primary endpoint is
indefinite.
- INCLUSION CRITERIA:
Healthy volunteer (health status confirmed by History and Physical Exam and blood work)
Ages 18 years or older (no upper limit)
Must be willing to allow samples to undergo genetic studies
EXCLUSION CRITERIA:
Patients with diseases with an inflammatory or immune component
Patients who have irregular circadian rhythms, i.e. those who are blind or work night
shifts
Patients with active infections requiring systemic antibiotic therapy
Use of immune modifying medications, i.e. NSAIDs (such as aspirin, ibuprofen (Advil,
Motrin), naproxen (Aleve), celecoxib (Celebrex), ketorolac (Toradol) within the past month
Systemic fungal, viral, or mycobacterial infections
Persons who are alcoholic or abusers of illicit substances
Abnormal fasting glucose >100mg/dL
Female subjects may not be pregnant or lactating due to possible side effects of use of
hydrocortisone in a non-benefit study
Liver function tests (AST, ALT, total bilirubin, alkaline phosphatase) above the normal
laboratory reference range
Other contraindications to corticosteroids (i.e. gastrointestinal ulceration, Cushing s
syndrome, congestive heart failure, uncontrolled hypertension, glaucoma, osteoporosis, or
known hypersensitivity to corticosteroids)
Corticosteroid use within the last six months prior to enrollment, including topical,
intra-articular or intramuscular injections, or inhaled administration
Prior use of systemically administered corticosteroids for >6 months duration
Use of azole medications or chronic opiates
Patients with psychiatric diagnoses or symptoms, to include hypomania, bipolar disorder,
major depression, or dysthymia
Patients with a body mass index greater than 30
Subjects unable to comprehend the investigational nature of the study or those who are
unable or unwilling to sign the consent
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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