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

Sponsor
National Center for Research Resources (NCRR) (NIH)
Overall Status
Unknown status
CT.gov ID
NCT00005105
Collaborator
Children's Hospital Medical Center, Cincinnati (Other)
75
Enrollment
5
Locations
15
Patients Per Site

Study Details

Study Description

Brief Summary

OBJECTIVES:
  1. 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 Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Study Start Date :
    Jan 1, 1997

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Months to 18 Years
      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

      Locations

      Site City State Country Postal Code
      1 Emory University School of Medicine Atlanta Georgia United States 30322
      2 James Whitcomb Riley Hospital for Children Indianapolis Indiana United States 46202-5225
      3 Schneider Children's Hospital New Hyde Park New York United States 11042
      4 Children's Hospital Medical Center - Cincinnati Cincinnati Ohio United States 45229-3039
      5 Medical College of Virginia School of Medicine Richmond Virginia United States 23298-0230

      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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00005105
      Other Study ID Numbers:
      • 199/14924
      • CHMC-C-96-10-4
      First Posted:
      Apr 7, 2000
      Last Update Posted:
      Jun 24, 2005
      Last Verified:
      Dec 1, 2003
      Keywords provided by , ,
      endocrine disorders
      intrauterine growth retardation
      rare disease
      Additional relevant MeSH terms:
      Fetal Growth Retardation

      Study Results

      No Results Posted as of Jun 24, 2005