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

May 15, 2007 updated by: University of Massachusetts, Worcester

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Investigators

  • Principal Investigator: Benjamin U Nwosu, MD, University of Massachusetts, Worcester
  • Study Director: Carol A Cicarrelli, RN, University of Massachusetts, Worcester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

October 6, 2005

First Submitted That Met QC Criteria

October 6, 2005

First Posted (Estimate)

October 10, 2005

Study Record Updates

Last Update Posted (Estimate)

May 17, 2007

Last Update Submitted That Met QC Criteria

May 15, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 305-SG01
  • H-11757

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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