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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 6, 2005

Last Updated Date

May 15, 2007

Start Date ^ICMJE

September 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00235599 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Insulin-Like Growth Factor Binding Protein-3 Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children.

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.

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Short Stature
Growth Hormone Deficiency

Intervention ^ICMJE

Procedure: IGFBP-3 Stimulation Test

Study Group/Cohort (s)

Not Provided

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

4 Years to 12 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00235599

Other Study ID Numbers ^ICMJE

305-SG01, H-11757

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Massachusetts, Worcester

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

University of Massachusetts, Worcester

Verification Date

May 2007

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

To Top