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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00235599
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : May 17, 2007
Information provided by:
University of Massachusetts, Worcester

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 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

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.

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
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

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00235599

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United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00235599    
Other Study ID Numbers: 305-SG01
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: May 17, 2007
Last Verified: May 2007
Keywords provided by University of Massachusetts, Worcester:
Additional relevant MeSH terms:
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Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs