Effects of Systemically Administered Hydrocortisone on the Immune System in Healthy Volunteers

NCT01281995 | Completed

• 2 other identifiers: 11009211-H-0092
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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....

Conditions

Immunosuppression; Healthy; Healthy Subjects

Keywords

Biologic Samples; Hydrocortisone; Laboratory Research Specimens; Glucocorticoids; Immune Modulation; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• Effects of hydrocortisone on the human immune

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• HENCH PS, KENDALL EC, SLOCUMB CH, POLLEY HF. Effects of cortisone acetate and pituitary ACTH on rheumatoid arthritis, rheumatic fever and certain other conditions. Arch Intern Med (Chic). 1950 Apr;85(4):545-666. doi: 10.1001/archinte.1950.00230100002001. No abstract available.

  PMID: 15411248 BACKGROUND

• Jaffe HL. THE INFLUENCE OF THE SUPRARENAL GLAND ON THE THYMUS : III. STIMULATION OF THE GROWTH OF THE THYMUS GLAND FOLLOWING DOUBLE SUPRARENALECTOMY IN YOUNG RATS. J Exp Med. 1924 Nov 30;40(6):753-9. doi: 10.1084/jem.40.6.753.

  PMID: 19868956 BACKGROUND

• Ashwell JD, Lu FW, Vacchio MS. Glucocorticoids in T cell development and function*. Annu Rev Immunol. 2000;18:309-45. doi: 10.1146/annurev.immunol.18.1.309.

  PMID: 10837061 BACKGROUND

Study Officials

• Angelique Biancotto, Ph.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 24, 2011
• Study Start: January 21, 2011
• Study Completion: August 30, 2018
• Last Updated: September 4, 2018

Record last verified: 2018-08-30

Locations

US (1)