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Growth Hormone Administration and the Human Immune System - II

This study is not yet open for participant recruitment.
Information provided by National Institute on Aging (NIA)

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Descriptive Information Fields
Brief Title  Growth Hormone Administration and the Human Immune System - II
Official Title  Growth Hormone Administration and the Human Immune System - II
Brief Summary

This study will investigate whether growth hormone, administered in a physiological or pulsatile (pulse-like) fashion, can elicit relevant changes in the human immune system while at the same time causing either no change or even an improvement in the metabolic profiles such as insulin sensitivity.

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 so that investigators can observe how the human body responds to this method versus daily injections. Specifically, investigators will look at any relevant changes in the human immune system, metabolic profile, and possible side effects.

GH will be administered via subcutaneous (below the skin) infusion pump in a pulsatile fashion compared with once-a-day bolus for 4 weeks. Participants will be wearing this infusion pump continuously for 4 weeks. This study involves two inpatient visits, two 1-day outpatient visits, and about 9-14 short outpatient visits over a 3 month period. Procedures during this study include blood draws, MRI, CT, DEXA scan, insulin clamp procedures, oral glucose tolerance tests, and urine tests

Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Immune Response [ Time Frame: Baseline, week 4, week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Metabolic profile [ Time Frame: Baseline, week 4, week 12 ] [ Designated as safety issue: No ]
Condition  Aging
Immune System
Intervention  Drug: human recombinant growth hormone (Growth Hormone)
Drug: Placebo
MEDLINE PMIDs 4081647,   3514161,   1460277,   8315380
Links
Recruitment Information Fields
Recruitment Status  Not yet recruiting
Enrollment  20
Start Date  June 2008
Completion Date June 2010
Eligibility 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
Gender Male
Ages 30 Years to 50 Years
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Charles Padgett, RN     410-350-7395     padgettca@nia.nih.gov    
Contact: Clinical Research Recruitment Office     410-350-3941     NIAStudiesRecruitment@mail.nih.gov    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00663611
Organization ID AG0101
Secondary IDs ††
Study Sponsor  National Institute on Aging (NIA)
Collaborators ††
Investigators 
Principal Investigator:     Chee W. Chia, MD     NIH/NIA/CRB    
Information Provided By National Institute on Aging (NIA)
Verification Date May 2008
First Received Date  April 21, 2008
Last Updated Date May 22, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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