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Growth Hormone Administration and the Human Immune System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier:
NCT00663611
First received: April 21, 2008
Last updated: September 7, 2016
Last verified: September 2016

April 21, 2008
September 7, 2016
October 2006
October 2014   (final data collection date for primary outcome measure)
GH administration may elicit clinical significant and relevant changes in the human immune system [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Immune Response [ Time Frame: Baseline, week 4, week 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00663611 on ClinicalTrials.gov Archive Site
Not Provided
Metabolic profile [ Time Frame: Baseline, week 4, week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Growth Hormone Administration and the Human Immune System
Growth Hormone Administration and the Human Immune System

Background:

- In elderly individuals, an age-associated decline in the immune system s ability to function is believed to contribute to increased incidence of infection, autoimmune disorders, and cancer. This decline in immune system function may be related to the decline in the body s production of growth hormone, which helps regulate human development and may contribute to the health of the immune system. Researchers are interested in studying whether growth hormone, given as an infusion over time, can improve the function of the immune system and other body systems associated with good health.

Objectives:

- To study the effects of growth hormone administration on the immune systems of healthy men.

Eligibility:

- Healthy men between 25 and 50 years of age.

Design:

  • This protocol will involve three separate studies: Study I, Study IB, and Study II. Participants in Study I and Study IB may participate in Study II as directed by the researchers.
  • Participants will be screened with a full medical history and physical examination, and will provide blood, urine, and stool samples; have a glucose tolerance test; and have other tests as required by the researchers.
  • Participants will have an infusion pump with a small catheter inserted beneath the skin to administer the study chemicals (either growth hormone or placebo).
  • Study I and Study IB participants will receive pulses of growth hormone through the infusion pump at regular intervals to monitor the body s response to the hormone. Study IB participants will receive a higher dose of growth hormone than Study I participants.
  • Throughout the study period, all participants will have frequent blood and urine tests, as well as tests of glucose tolerance and metabolism, imaging studies, and other tests as required by the researchers.
  • Study II participants will be divided into two groups. The first group will receive pulses of either growth hormone or placebo infusion at intervals throughout the day for 4 weeks, followed by an 8-week period without infusions. The second group will receive conventional once-a-day infusion of growth hormone or placebo for 4 weeks, followed by an 8-week period without infusions.
  • Throughout the study period, all participants will have frequent blood and urine tests, as well as tests of glucose tolerance and metabolism, imaging studies, and other tests as required by the researchers.

Objectives and Specific Aims:

We plan to investigate whether growth hormone, administered in a physiological or pulsatile fashion, can elicit relevant changes in the human immune system while at the same time associated with no change or even an improvement in the metabolic profiles such as insulin sensitivity.

Experimental Design and Methods:

Thirty-eight healthy men, age 25-50, will be recruited for this study. There are three parts to this study: Study I, Study IB and Study II. Study I and IB each involve six subjects and are designed to test the hypothesis that pulsatile subcutaneous infusion of GH via a subcutaneous infusion pump will yield a reasonable pulsatile GH pattern. The dose of GH used in Study IB will be three-fold higher that that in Study I. Study I and IB will be done first before proceeding to Study II.

Study II is a randomized, double-blinded, placebo-controlled 12-week study involving 26 subjects divided into 2 groups: Group A and Group B. Group A will involve 13 subjects receiving pulsatile GH or placebo infusion for 4 weeks with 8-week washout after intervention. Group B will involve 13 subjects receiving conventional once a day subcutaneous infusion of GH or placebo for 4 weeks with 8-week washout after intervention.

Medical Relevance and Expected Outcome:

This study will ascertain the significance of the effect of pulsatile growth hormone administration on the human immune system and metabolic profile.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy
  • Drug: Norditropin
    A polypeptide hormone of recombinant DNA origin.
  • Drug: Placebo
  • Experimental: Study I - IB
    Each involve six subjects & are designed to test the hypothesis that pulsatile subcutaneous infusion of GH via a subcutaneous infusion pump will yield a reasonable pulsatile GH pattern. The dose of GH used in Study IB will be three-fold higher than that in Study I. Study I and IB will be done first before proceeding to Study II
    Interventions:
    • Drug: Norditropin
    • Drug: Placebo
  • Experimental: Study II
    Is a randomized, double-blinded, placebo-controlled 12 week study involving 26 subjects divided into 2 groups: Group A and Group B. Group A will involve 13 subjects receiving pulsatile GH or placebo infusion for 4 weeks with 8 week washout after intervention. Group B will involve 13 subjects receiving conventional once a day subcutaneous infusion of GH or placebo for 4 weeks with 8 week washout after intervention.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
October 2014
October 2014   (final data collection date for primary outcome measure)
  • INCLUSION CRITERIA:

    1. Healthy men only
    2. Age 25-50
    3. Screening laboratory evaluations with no clinically significant abnormal results (minor deviations from normal lab results will be at the discretion of the principal investigator):

      1. fasting comprehensive metabolic panel
      2. complete blood count with differential and platelets
      3. 75-gram oral glucose tolerance test (OGTT)

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

EXCLUSION CRITERIA:

  1. Women
  2. FPG 100 mg/dL or 2-hour OGTT 140 mg/dL
  3. Abnormal electrocardiogram (EKG) suggesting possible underlying cardiac conditions that, in the opinion of the investigator(s), may cause participation of the subject in the study unsafe
  4. Positive stool guaiac
  5. Evidence of illicit drug use
  6. History of smoking any tobacco products within one year prior to screening
  7. Alcohol intake > 30 grams (drink more than 2 beers per day OR equivalent amount of alcohol)
  8. History of Human Immunodeficiency Virus (HIV) infection
  9. History of active or chronic Hepatitis B and/or C infection
  10. History of malignancy
  11. History of coronary disease
  12. History of seizures or other neurologic diseases
  13. History of liver or renal diseases
  14. History of gastrointestinal or endocrine disorders
  15. History of glucocorticoid use (over one month) or other immunosuppressive agents (any)
  16. unable to undergo a magnetic resonance imaging (MRI) procedure
  17. Any medical history that, in the opinion of the investigator(s), will make participation of the subject in the study unsafe
Male
20 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00663611
999907260, 07-AG-N260
Not Provided
Not Provided
Not Provided
National Institute on Aging (NIA)
National Institute on Aging (NIA)
Not Provided
Principal Investigator: Josephine M Egan, M.D. National Institute on Aging (NIA)
National Institutes of Health Clinical Center (CC)
September 2016

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