Growth Hormone Administration and the Human Immune System - I

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier:
NCT00663676
First received: April 21, 2008
Last updated: September 17, 2013
Last verified: September 2013
  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 Phase
Aging
Immune System and Related Disorders
Drug: human recombinant growth hormone (Growth Hormone)
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Growth Hormone Administration and the Human Immune System - I

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

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: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group 1
Test the hypothesis that pulsatile subcutaneous infusion of Growth Hormone (GH) via a pump will yield a reasonable pulsatile GH pattern.
Drug: human recombinant growth hormone (Growth Hormone)
administered via a subcutaneous infusion pump for 24 hours
Other Name: Norditropin (somatropin, rDNA origin)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663676

Locations
United States, Maryland
National Institute on Aging Clinical Research Unit
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Investigators
Principal Investigator: Chee W. Chia, MD NIH/NIA/CRB
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier: NCT00663676     History of Changes
Other Study ID Numbers: AG0100
Study First Received: April 21, 2008
Last Updated: September 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Thymus
glucose
metabolism
pulsatile
insulin

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

ClinicalTrials.gov processed this record on August 21, 2014