Low Dose Growth Hormone Treatment in Subjects With Metabolic Syndrome.
Status:
Withdrawn
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
Study hypothesis:
Low dose growth hormone (GH), through its generation of free 'bioavailable' insulin-like
growth factor (IGF)-I, can improve insulin sensitivity and the metabolic profile of subjects
with metabolic syndrome.
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) and fat deposition in subjects with
metabolic syndrome.
Study design: Subjects that satisfy the criteria of metabolic syndrome (central obesity,
treated or untreated high blood pressure, high cholesterol and impaired fasting glucose
levels) will be invited to participate in this study. The subjects will be assessed at the
initial visit to ascertain their suitability before further participation in the study. If
eligible, an equal number of men and women will be randomized (like a flip of a coin) to
receive either daily low dose GH or placebo injections first for 12 weeks, before exchanging
over for another 12 weeks of treatment after a 4-week washout period. Before, during and
after treatment, the subjects will be assessed at frequently with blood tests, scans and fat
biopsies. During the study, the subjects will be studied 4 times at the Oregon Clinical and
Translational Research Institute (OCTRI). At the first, second 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 insulin-like growth factor-I (a hormone stimulated by
growth hormone in the body) in fat; whereas blood tests to examine how well insulin works in
the body (insulin sensitivity) will be collected at all visits of the study.