Growth Hormone Administration and the Human Immune System
Objectives and Specific Aims:
We plan to investigate whether growth hormone, administered in a physiological or pulsatile
fashion, can elicit relevant changes in the human immune system while at the same time
associated with no change or even an improvement in the metabolic profiles such as insulin
Experimental Design and Methods:
Thirty-eight healthy men, age 25-50, will be recruited for this study. There are three parts
to this study: Study I, Study IB and Study II. Study I and IB each involve six subjects and
are designed to test the hypothesis that pulsatile subcutaneous infusion of GH via a
subcutaneous infusion pump will yield a reasonable pulsatile GH pattern. The dose of GH used
in Study IB will be three-fold higher that that in Study I. Study I and IB will be done
first before proceeding to Study II.
Study II is a randomized, double-blinded, placebo-controlled 12-week study involving 26
subjects divided into 2 groups: Group A and Group B. Group A will involve 13 subjects
receiving pulsatile GH or placebo infusion for 4 weeks with 8-week washout after
intervention. Group B will involve 13 subjects receiving conventional once a day
subcutaneous infusion of GH or placebo for 4 weeks with 8-week washout after intervention.
Medical Relevance and Expected Outcome:
This study will ascertain the significance of the effect of pulsatile growth hormone
administration on the human immune system and metabolic profile.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
GH administration may elicit clinical significant and relevant changes in the human immune system
Chee W Chia, M.D.
National Institute on Aging (NIA)
United States: Federal Government
|National Institute of Aging, Clinical Research Unit||Baltimore, Maryland 21224|