Growth Hormone Deficiency Clinical Trial
Official title:
The Insulin-Like Growth Factor Binding Protein-3 Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children.
This project is designed to answer the question: Is there an acute IGFBP-3 response in
normal children?
Our specific hypothesis states that under the influence of growth hormone secretagogues,
intact IGFBP-3 molecule will undergo proteolysis and liberate IGFBP-3 fragments, along with
other components of the ternary complex. This proteolysis will result in measurable rise in
IGFBP-3, which will indicate the subject’s growth hormone status. Short children with growth
hormone deficiency will not show an IGFBP-3 response.
The diagnosis of growth hormone deficiency is problematic, given the shortcoming of the
standard growth hormone stimulation test. This study is designed to investigate a new tool
for the diagnosis of growth hormone deficiency.
Ten short, prepubertal children, who fulfill the inclusion criteria, will undergo a
two-secretagogue standard growth hormone stimulation test, and an insulin like growth factor
binding protein-3 (IGFBP-3) stimulation test simultaneously. During this test, components of
the ternary complex moieties, viz, insulin-like growth factor-I (IGF-I), IGFBP-3 and acid
labile subunit (ALS) will also be measured along with growth hormone.
The aim of this study is to detect an acute rise in IGFBP-3 of >15% from baseline.
The importance of this study is that it inculcates the specificity and improved sensitivity
of stimulated IGFBP-3 in the diagnosis of growth hormone deficiency.
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Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional
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