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Growth Hormone Administration and the Human Immune System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00663611
First Posted: April 22, 2008
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
  Purpose

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.

Condition Intervention Phase
Healthy Drug: Norditropin Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Growth Hormone Administration and the Human Immune System

Resource links provided by NLM:


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

Primary Outcome Measures:
  • GH administration may elicit clinical significant and relevant changes in the human immune system [ Time Frame: 4 weeks ]

Estimated Enrollment: 150
Study Start Date: October 19, 2006
Study Completion Date: October 6, 2014
Primary Completion Date: October 6, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Norditropin
A polypeptide hormone of recombinant DNA origin.
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.
Drug: Placebo

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663611


Locations
United States, Maryland
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
National Institute on Aging (NIA)
Investigators
Principal Investigator: Josephine M Egan, M.D. National Institute on Aging (NIA)
  More Information

Publications:
Responsible Party: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00663611     History of Changes
Obsolete Identifiers: NCT00663676
Other Study ID Numbers: 999907260
07-AG-N260
First Submitted: April 21, 2008
First Posted: April 22, 2008
Last Update Posted: October 6, 2017
Last Verified: December 8, 2016

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) ):
Immune Function
Metabolism
Pulsatile Growth Hormone

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