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The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children.

This study has been completed.
Sponsor:
Information provided by:
University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00235599
First received: October 6, 2005
Last updated: May 15, 2007
Last verified: May 2007

October 6, 2005
May 15, 2007
September 2005
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Complete list of historical versions of study NCT00235599 on ClinicalTrials.gov Archive Site
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The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children.
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.

Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
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  • Short Stature
  • Growth Hormone Deficiency
Procedure: IGFBP-3 Stimulation Test
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Nwosu BU, Soyka LA, Angelescu A, Lee MM. Evidence of insulin-like growth factor binding protein-3 proteolysis during growth hormone stimulation testing. J Pediatr Endocrinol Metab. 2011;24(3-4):163-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
October 2006
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Inclusion Criteria:

  • Bone age < 10 years female, < 12 years male
  • Pubertal status: Girls: Tanner I for breast development. Boys: testicular volume of ≤ 3 cc, as measured by the standardized orchidometer (Prader type). The onset of pubic hair development up to and including Tanner III is allowed in the study.
  • Adequate nutrition: body mass index ≥ 25th percentile for gender.

Exclusion Criteria:

  • Syndromic short stature
  • Chronic illnesses.
  • Other disorders, including osteo- or chondrodystrophies, and endocrine causes of short stature such as Cushing syndrome, and untreated hypothyroidism.
Both
4 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00235599
305-SG01, H-11757
No
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University of Massachusetts, Worcester
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Principal Investigator: Benjamin U Nwosu, MD University of Massachusetts, Worcester
Study Director: Carol A Cicarrelli, RN University of Massachusetts, Worcester
University of Massachusetts, Worcester
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP