Aging Clinical Trial
Official title:
Growth Hormone Administration and the Human Immune System - I
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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