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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

April 21, 2008
September 17, 2013
September 2007
December 2013   (final data collection date for primary outcome measure)
Plasma GH levels [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00663676 on ClinicalTrials.gov Archive Site
Metabolic profile [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Growth Hormone Administration and the Human Immune System - I
Growth Hormone Administration and the Human Immune System - I

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.

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.

Interventional
Phase 0
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aging
  • Immune System and Related Disorders
Drug: human recombinant growth hormone (Growth Hormone)
administered via a subcutaneous infusion pump for 24 hours
Other Name: Norditropin (somatropin, rDNA origin)
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.
Intervention: Drug: human recombinant growth hormone (Growth Hormone)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
6
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Male
30 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00663676
AG0100
No
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
National Institute on Aging (NIA)
Not Provided
Principal Investigator: Chee W. Chia, MD NIH/NIA/CRB
National Institutes of Health Clinical Center (CC)
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP