Genetic Study of Insulin-Like Growth Factor-I Receptor Mutations in Patients With Intrauterine Growth Retardation

This study is currently recruiting participants.

Verified by National Center for Research Resources (NCRR), December 2003

First Received: April 6, 2000 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Children's Hospital Medical Center, Cincinnati
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00005105

Purpose

OBJECTIVES:

I. Determine if mutations in the gene encoding the insulin-like growth factor-I receptor lead to relative insulin-like growth factor-I insensitivity and produce intrauterine growth retardation in children.

Condition
Intrauterine Growth Retardation

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment:	75
Study Start Date:	January 1997

Detailed Description:

PROTOCOL OUTLINE:

Patients undergo blood draw. Insulin-like growth factor-I (IGF-I) and insulin-like growth factor binding protein-3 (IGFBP-3) are measured. Patients whose IGF-I and IGFBP-3 levels are average or above are tested for the presence of mutation in the insulin-like growth factor-I receptor.

Eligibility

Ages Eligible for Study:	18 Months to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Intrauterine growth retardation (IUGR), defined as birth weight less than 2 standard deviations below the mean by Usher and McLean Deficient "catch-up" growth (stature less than 5th percentile on growth chart after age 18 months) Normal or elevated circulating concentrations of insulin-like growth factor-I (IGF-I) and insulin-like growth factor binding protein-3 (IGFBP-3) IGF-I or IGFBP-3 within or above the 95th percentile confidence interval for age No other clinical explanation for poor prenatal and postnatal growth No IUGR due to maternal toxemia, endocrine disease, gastrointestinal disease, significant heart disease, or chromosomal abnormalities No other condition known to retard growth

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005105

Locations

United States, Georgia
Emory University School of Medicine	Terminated
Atlanta, Georgia, United States, 30322
United States, Indiana
James Whitcomb Riley Hospital for Children	Active, not recruiting
Indianapolis, Indiana, United States, 46202-5225
United States, New York
Schneider Children's Hospital	Recruiting
New Hyde Park, New York, United States, 11042
Contact: Graeme Frank 718-470-3390
United States, Ohio
Children's Hospital Medical Center - Cincinnati	Recruiting
Cincinnati, Ohio, United States, 45229-3039
Contact: Steven D. Chernausek 513-636-4744
United States, Virginia
Medical College of Virginia School of Medicine	Recruiting
Richmond, Virginia, United States, 23298-0230
Contact: Paul Kaplowitz 804-786-9788

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Children's Hospital Medical Center, Cincinnati

Investigators

Study Chair:

Steven D. Chernausek

Children's Hospital Medical Center, Cincinnati

More Information

No publications provided

Study ID Numbers:	199/14924, CHMC-C-96-10-4
Study First Received:	April 6, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00005105 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):

endocrine disorders
intrauterine growth retardation
rare disease

Study placed in the following topic categories:

Fetal Diseases
Pregnancy Complications
Growth Disorders
Rare Diseases
Mitogens

Endocrine System Diseases
Endocrinopathy
Insulin
Fetal Growth Retardation

Additional relevant MeSH terms:

Fetal Diseases
Pathologic Processes
Pregnancy Complications
Growth Disorders
Fetal Growth Retardation

ClinicalTrials.gov processed this record on May 07, 2009