The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children.
|ClinicalTrials.gov Identifier: NCT00235599|
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : May 17, 2007
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.
|Condition or disease||Intervention/treatment|
|Short Stature Growth Hormone Deficiency||Procedure: IGFBP-3 Stimulation Test|
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.
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Observational Model:||Defined Population|
|Official Title:||The Insulin-Like Growth Factor Binding Protein-3 Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children.|
|Study Start Date :||September 2005|
|Actual Study Completion Date :||October 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00235599
|United States, Massachusetts|
|University of Massachusetts Medical School|
|Worcester, Massachusetts, United States, 01655|
|Principal Investigator:||Benjamin U Nwosu, MD||University of Massachusetts, Worcester|
|Study Director:||Carol A Cicarrelli, RN||University of Massachusetts, Worcester|