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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005105
First Posted: April 7, 2000
Last Update Posted: December 9, 2005
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.
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by:
National Center for Research Resources (NCRR)
  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

Study Type: Observational
Study Design: Primary Purpose: 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

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
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
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


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

ClinicalTrials.gov Identifier: NCT00005105     History of Changes
Other Study ID Numbers: 199/14924
CHMC-C-96-10-4
First Submitted: April 6, 2000
First Posted: April 7, 2000
Last Update Posted: December 9, 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