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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Growth Hormone Administration and the Human Immune System - I|
- Plasma GH levels [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
- Metabolic profile [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
GH administered in a pulsatile fashion
Drug: human recombinant growth hormone (Growth Hormone)
administered via a subcutaneous infusion pump for 24 hours
Other Name: human recombinant growth hormone
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.
|United States, Maryland|
|National Institute on Aging Clinical Research Unit|
|Baltimore, Maryland, United States, 21225|
|Principal Investigator:||Chee W. Chia, MD||NIH/NIA/CRB|