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Sponsored by: |
National Institute on Aging (NIA) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00663611 |
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 |
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Aging Immune System |
Drug: human recombinant growth hormone (Growth Hormone) Drug: Placebo |
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 |
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 |
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A1: Experimental
GH administered in a pulsatile fashion
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Drug: human recombinant growth hormone (Growth Hormone)
8 mcg/kg/day administered via a subcutaneous infusion pump for 4 weeks
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B1: Experimental
GH administered as once-a-day bolus
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Drug: human recombinant growth hormone (Growth Hormone)
8 mcg/kg/day administered via a subcutaneous infusion pump for 4 weeks
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A2: Placebo Comparator
Placebo administered in a pulsatile fashion
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Drug: Placebo
Administered via a subcutaneous infusion pump for 4 weeks
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B2: Placebo Comparator
Placebo administered as once-a-day bolus
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Drug: Placebo
Administered via a subcutaneous infusion pump for 4 weeks
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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
Ages Eligible for Study: | 30 Years to 50 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Screening laboratory evaluations with no clinically significant abnormal results
75-gram oral glucose tolerance test (OGTT)
Exclusion Criteria:
Contact: Charles Padgett, RN | 410-350-7395 | padgettca@nia.nih.gov |
Contact: Clinical Research Recruitment Office | 410-350-3941 | NIAStudiesRecruitment@mail.nih.gov |
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 |
Principal Investigator: | Chee W. Chia, MD | NIH/NIA/CRB |
Responsible Party: | NIH/NIA/CRB ( Chee W. Chia, MD ) |
Study ID Numbers: | AG0101 |
Study First Received: | April 21, 2008 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00663611 |
Health Authority: | United States: Federal Government |
Thymus glucose metabolism pulsatile insulin |
Insulin |