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Growth Hormone Administration and the Human Immune System - I
This study is currently recruiting participants.
Verified by National Institute on Aging (NIA), December 2008
First Received: April 21, 2008   Last Updated: December 29, 2008   History of Changes
Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00663676
  Purpose

This study is designed to test the hypothesis that pulsatile (pulse-like) subcutaneous (under the skin) infusion of growth hormone (GH) via a pump will yield a reasonable pulsatile GH pattern.


Condition Intervention
Aging
Immune System
Drug: human recombinant growth hormone (Growth Hormone)

Drug Information available for: Somatropin Somatotropin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title: Growth Hormone Administration and the Human Immune System - I

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Plasma GH levels [ Time Frame: 36 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Metabolic profile [ Time Frame: 36 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 6
Study Start Date: September 2007
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
GH administered in a pulsatile fashion
Drug: human recombinant growth hormone (Growth Hormone)
administered via a subcutaneous infusion pump for 24 hours

Detailed Description:

Growth hormone (GH) may enhance the way the human immune system responds. The human body secretes GH in a pulse-like fashion throughout the day. In this study human recombinant GH will be given using a continuous infusion pump to imitate how GH is naturally secreted.

This study, Study I, involves six subjects and is designed to test the hypothesis that pulsatile subcutaneous infusion of GH via a pump will yield a reasonable pulsatile GH pattern. Study I involves one inpatient visit. Procedures during this study include blood draws, MRI, and insulin clamp procedures.

Study I will be followed by Study Ib, with the same six participants. Study Ib will test the hypothesis that pulsatile subcutaneous infusion of GH via a pump will yield a reasonable pulsatile GH pattern. GH will be administered at three times the dose that was used in Study I. Study Ib involves one screening visit and one inpatient overnight visit. No MRI or insulin clamp procedure will be performed.

This study will be followed by Study II, which is the main study and will examine the effects of GH via subcutaneous infusion pump in a pulsatile fashion compared with once-a-day bolus for 4 weeks.

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men only
  • Screening laboratory evaluations with no clinically significant abnormal results

    • fasting comprehensive metabolic panel
    • complete blood count with differential and platelets
    • 75-gram oral glucose tolerance test (OGTT)

      • fasting plasma glucose (FPG) less than 100 mg/dL
      • 2-hr OGTT less than 140 mg/dL
    • Insulin-like growth factor-I (IGF-I)
    • thyroid function test (TSH, free T3, free T4)
    • fasting lipid profile
  • BMI less than 30
  • Have NOT participated in another clinical trial involving any pharmacologic agents within the past 60 days
  • Able to complete an informed consent
  • Agree to not participate in other clinical trials within the study period

Exclusion Criteria:

  • Women
  • FPG 100 mg/dL or higher, or 2-hour OGTT 140 mg/dL or higher
  • Abnormal Electrocardiogram (EKG)
  • Positive stool guaiac
  • Evidence of illicit drug use
  • History of smoking any tobacco products within one year prior to screening
  • Alcohol intake greater than 30 grams (drink more than 2 beers per day OR equivalent amount of alcohol)
  • History of Human Immunodeficiency Virus (HIV) infection
  • History of active or chronic Hepatitis B and/or C infection
  • History of malignancy
  • History of coronary disease
  • History of seizures or other neurologic diseases
  • History of liver or renal diseases
  • History of gastrointestinal or endocrine disorders
  • History of glucocorticoid use (over one month) or other immunosuppressive agents (any)
  • Unable to undergo a magnetic resonance imaging (MRI) procedure
  • Any medical history that, in the opinion of the investigator(s), will make participation in the study unsafe
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663676

Contacts
Contact: Charles Padgett, RN 410-350-7395 padgettca@nia.nih.gov
Contact: Clinical Research Recruitment Office 410-350-3941 NIAStudiesRecruitment@mail.nih.gov

Locations
United States, Maryland
National Institute on Aging Clinical Research Recruiting
Baltimore, Maryland, United States, 21225
Contact: Charles Padgett, RN     410-350-7395     padgettca@nia.nih.gov    
Principal Investigator: Chee Chia, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Chee W. Chia, MD NIH/NIA/CRB
  More Information

Publications:
Responsible Party: NIH/NIA/CRB ( Chee W. Chia, MD )
Study ID Numbers: AG0100
Study First Received: April 21, 2008
Last Updated: December 29, 2008
ClinicalTrials.gov Identifier: NCT00663676     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Thymus
glucose
metabolism
pulsatile
insulin

Study placed in the following topic categories:
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Insulin

Additional relevant MeSH terms:
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009