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

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ClinicalTrials.gov Identifier: NCT00005105
Recruitment Status : Unknown
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was:  Recruiting
First Posted : April 7, 2000
Last Update Posted : June 24, 2005
Information provided by:

Study Description
Brief Summary:


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 or disease
Intrauterine Growth Retardation

Detailed Description:


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.

Study Design

Study Type : Observational
Estimated Enrollment : 75 participants
Primary Purpose: Screening
Study Start Date : January 1997
Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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

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 ClinicalTrials.gov identifier (NCT number): NCT00005105

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
Study Chair: Steven D. Chernausek Children's Hospital Medical Center, Cincinnati
More Information

ClinicalTrials.gov Identifier: NCT00005105     History of Changes
Other Study ID Numbers: 199/14924
First Posted: April 7, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2003

Keywords provided by National Center for Research Resources (NCRR):
endocrine disorders
intrauterine growth retardation
rare disease

Additional relevant MeSH terms:
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes