The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children.
NCT ID: NCT00235599
Last Updated: 2007-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10 participants
OBSERVATIONAL
2005-09-30
2006-10-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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DEFINED_POPULATION
OTHER
Interventions
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IGFBP-3 Stimulation Test
Eligibility Criteria
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Inclusion Criteria
* 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
* Chronic illnesses.
* Other disorders, including osteo- or chondrodystrophies, and endocrine causes of short stature such as Cushing syndrome, and untreated hypothyroidism.
4 Years
12 Years
ALL
Yes
Sponsors
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University of Massachusetts, Worcester
OTHER
Principal Investigators
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Benjamin U Nwosu, MD
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts, Worcester
Carol A Cicarrelli, RN
Role: STUDY_DIRECTOR
University of Massachusetts, Worcester
Locations
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University of Massachusetts Medical School
Worcester, Massachusetts, United States
Countries
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References
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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. doi: 10.1515/jpem.2011.088.
Other Identifiers
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H-11757
Identifier Type: -
Identifier Source: secondary_id
305-SG01
Identifier Type: -
Identifier Source: org_study_id