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Growth Hormone Administration and the Human Immune System - II

This study is not yet open for participant recruitment.
Verified by National Institute on Aging (NIA), May 2008

Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00663611
  Purpose

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.


Condition Intervention
Aging
Immune System
Drug: human recombinant growth hormone (Growth Hormone)
Drug: Placebo

ChemIDplus related topics:   Insulin   Dextrose   Somatotropin   Somatropin  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Growth Hormone Administration and the Human Immune System - II

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Immune Response [ Time Frame: Baseline, week 4, week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Metabolic profile [ Time Frame: Baseline, week 4, week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:   20
Study Start Date:   June 2008
Estimated Study Completion Date:   June 2010
Estimated Primary Completion Date:   February 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A1: Experimental
GH administered in a pulsatile fashion
Drug: human recombinant growth hormone (Growth Hormone)
8 mcg/kg/day administered via a subcutaneous infusion pump for 4 weeks
B1: Experimental
GH administered as once-a-day bolus
Drug: human recombinant growth hormone (Growth Hormone)
8 mcg/kg/day administered via a subcutaneous infusion pump for 4 weeks
A2: Placebo Comparator
Placebo administered in a pulsatile fashion
Drug: Placebo
Administered via a subcutaneous infusion pump for 4 weeks
B2: Placebo Comparator
Placebo administered as once-a-day bolus
Drug: Placebo
Administered via a subcutaneous infusion pump for 4 weeks

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

  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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663611

Contacts
Contact: Charles Padgett, RN     410-350-7395     padgettca@nia.nih.gov    
Contact: Clinical Research Recruitment Office     410-350-3941     NIAStudiesRecruitment@mail.nih.gov    

Locations
United States, Maryland
National Institute on Aging Clinical Research     Recruiting
      Baltimore, Maryland, United States, 21225
      Contact: Charles Padgett, RN     410-350-7395     padgettca@nia.nih.gov    
      Principal Investigator: Chee Chia, MD            

Sponsors and Collaborators

Investigators
Principal Investigator:     Chee W. Chia, MD     NIH/NIA/CRB    
  More Information

Publications:

Responsible Party:   NIH/NIA/CRB ( Chee W. Chia, MD )
Study ID Numbers:   AG0101
First Received:   April 21, 2008
Last Updated:   May 22, 2008
ClinicalTrials.gov Identifier:   NCT00663611
Health Authority:   United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Thymus  
glucose  
metabolism  
pulsatile  
insulin  

Study placed in the following topic categories:
Insulin

ClinicalTrials.gov processed this record on July 03, 2008




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