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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. |
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| 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 |
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| 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 |
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| Intervention † | Drug: human recombinant growth hormone (Growth Hormone) Drug: Placebo |
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| 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:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 30 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00663611 | ||||||||
| Organization ID | AG0101 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | National Institute on Aging (NIA) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute on Aging (NIA) | ||||||||
| Verification Date | May 2008 | ||||||||
| First Received Date † | April 21, 2008 | ||||||||
| Last Updated Date | May 22, 2008 | ||||||||