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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 21, 2008 | ||||||||
| Last Updated Date | December 29, 2008 | ||||||||
| Start Date ICMJE | June 2008 | ||||||||
| Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Immune Response [ Time Frame: Baseline, week 4, week 12 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00663611 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Metabolic profile [ Time Frame: Baseline, week 4, week 12 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Growth Hormone Administration and the Human Immune System - II | ||||||||
| Official Title ICMJE | 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 ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | June 2010 | ||||||||
| Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 30 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00663611 | ||||||||
| Responsible Party | Chee W. Chia, MD, NIH/NIA/CRB | ||||||||
| Study ID Numbers ICMJE | AG0101 | ||||||||
| Study Sponsor ICMJE | National Institute on Aging (NIA) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute on Aging (NIA) | ||||||||
| Verification Date | December 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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