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| Sponsor: | University of Massachusetts |
|---|---|
| Information provided by: | University of Massachusetts |
| ClinicalTrials.gov Identifier: | NCT00235599 |
Purpose
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 | Intervention |
|---|---|
|
Short Stature Growth Hormone Deficiency |
Procedure: IGFBP-3 Stimulation Test |
| Study Type: | Observational |
| Study Design: | Screening, Cross-Sectional, Defined Population, Prospective Study |
| Official Title: | The Insulin-Like Growth Factor Binding Protein-3 Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children. |
| Enrollment: | 10 |
| Study Start Date: | September 2005 |
| Study Completion Date: | October 2006 |
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.
Eligibility| Ages Eligible for Study: | 4 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| University of Massachusetts Medical School | |
| Worcester, Massachusetts, United States, 01655 | |
| Principal Investigator: | Benjamin U Nwosu, MD | University of Massachusetts Medical School |
| Study Director: | Carol A Cicarrelli, RN | University of Massachusetts Medical School |
More Information
| Study ID Numbers: | 305-SG01, H-11757 |
| Study First Received: | October 6, 2005 |
| Last Updated: | May 15, 2007 |
| ClinicalTrials.gov Identifier: | NCT00235599 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Growth Hormone Deficiency |
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Dwarfism Bone Diseases, Endocrine Hypothalamic Diseases Pituitary Diseases Physiological Effects of Drugs Nervous System Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Central Nervous System Diseases |
Dwarfism, Pituitary Brain Diseases Hormones Bone Diseases Pharmacologic Actions Musculoskeletal Diseases Hypopituitarism Bone Diseases, Developmental |
