Low Dose Growth Hormone (GH) on Insulin Sensitivity and Cortisol Production Rates
Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
Summary
Study hypothesis:
Growth hormone (GH), through its generation of free 'bioavailable' insulin-like growth factor
(IGF)-I, can improve insulin sensitivity in adults with GH deficiency.
Study aims:
The purpose of this study is to determine the mechanism of how low dose GH treatment affects
the body's sensitivity to insulin actions and whether this low GH dose can affect the body's
handling of steroid hormone levels (cortisol clearance) in adults with GH deficiency.
Study design:
Men and women with confirmed GH deficiency, but not recently been on GH treatment will be
invited to participate in this study. The subjects will be assessed at the initial visit to
ascertain their suitability before further participating in the study. If suitable, an equal
number of men and women will be randomized to receive either low dose GH or placebo injection
for 3 months. Before, during and after treatment, the subjects will be assessed at regularly
with blood tests, scans and fat biopsies. At the first and final visit, testing will include
scans to measure the amount of whole body fat and fat in the stomach area, muscle, and liver;
blood tests to measure levels of cortisol, and fat tissue (taken from a biopsy) analysis to
measure the density of IGF-I in the muscle; whereas blood tests to examine insulin
sensitivity will also be collected. This study will use Genotropin and Genotropin pen
devices, and the the data will be analyzed using a computer statistical program where the
identity of the subjects will be coded to maintain confidentiality.