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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: | NCT00663676 |
This study is designed to test the hypothesis that pulsatile (pulse-like) subcutaneous (under the skin) infusion of growth hormone (GH) via a pump will yield a reasonable pulsatile GH pattern.
Condition | Intervention |
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Aging Immune System |
Drug: human recombinant growth hormone (Growth Hormone) |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Growth Hormone Administration and the Human Immune System - I |
Estimated Enrollment: | 6 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
GH administered in a pulsatile fashion
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Drug: human recombinant growth hormone (Growth Hormone)
administered via a subcutaneous infusion pump for 24 hours
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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.
This study, Study I, involves six subjects and is designed to test the hypothesis that pulsatile subcutaneous infusion of GH via a pump will yield a reasonable pulsatile GH pattern. Study I involves one inpatient visit. Procedures during this study include blood draws, MRI, and insulin clamp procedures.
Study I will be followed by Study Ib, with the same six participants. Study Ib will test the hypothesis that pulsatile subcutaneous infusion of GH via a pump will yield a reasonable pulsatile GH pattern. GH will be administered at three times the dose that was used in Study I. Study Ib involves one screening visit and one inpatient overnight visit. No MRI or insulin clamp procedure will be performed.
This study will be followed by Study II, which is the main study and will examine the effects of GH via subcutaneous infusion pump in a pulsatile fashion compared with once-a-day bolus for 4 weeks.
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: | AG0100 |
Study First Received: | April 21, 2008 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00663676 |
Health Authority: | United States: Federal Government |
Thymus glucose metabolism pulsatile insulin |
Insulin |