Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235599
Status:
COMPLETED
Last Update Posted:
2007-05-17
First Post:
2005-10-06
Brief Title:
The IGFBP-3 Stimulation Test A New Tool for the Diagnosis of Growth Hormone Deficiency in Children
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
The Insulin-Like Growth Factor Binding Protein-3 Test A New Tool for the Diagnosis of Growth Hormone Deficiency in Children
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 subjects growth hormone status Short children with growth hormone deficiency will not show an IGFBP-3 response
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 subjects growth hormone status Short children with growth hormone deficiency will not show an IGFBP-3 response
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H-11757 | None | None | None |