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

NCT ID: NCT00005105

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intrauterine Growth Retardation

Keywords

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endocrine disorders intrauterine growth retardation rare disease

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Research Resources (NCRR)

NIH

Sponsor Role lead

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role collaborator

Principal Investigators

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Steven D. Chernausek

Role: STUDY_CHAIR

Children's Hospital Medical Center, Cincinnati

Locations

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Emory University School of Medicine

Atlanta, Georgia, United States

Site Status TERMINATED

James Whitcomb Riley Hospital for Children

Indianapolis, Indiana, United States

Site Status ACTIVE_NOT_RECRUITING

Schneider Children's Hospital

New Hyde Park, New York, United States

Site Status RECRUITING

Children's Hospital Medical Center - Cincinnati

Cincinnati, Ohio, United States

Site Status RECRUITING

Medical College of Virginia School of Medicine

Richmond, Virginia, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Graeme Frank

Role: primary

Steven D. Chernausek

Role: primary

Paul Kaplowitz

Role: primary

Other Identifiers

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CHMC-C-96-10-4

Identifier Type: -

Identifier Source: secondary_id

199/14924

Identifier Type: -

Identifier Source: org_study_id