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Impaired Insulin-like Growth Factor-1 (IGF-1) Generation Causes Protein Catabolism and Poor Growth in Children With Crohn Disease

Terminated
Conditions
Crohns Disease
Interventions
Other: Examinations
Registration Number
NCT00946361
Lead Sponsor
Nationwide Children's Hospital
Brief Summary

The investigators will prospectively recruit 26 children with moderate - severe active Crohn disease (PCDAI \>30). Results will be compared to 26 patients in sustained remission (PCDAI \<10 and physician global assessment of remission over the previous 6 months) who are matched for age and gender. Subjects will be studied at baseline and six months. The primary study end-points will be leucine rate of appearance (a measure of protein breakdown) and IGF-1 levels.

This study will test the hypothesis that children with greater disease severity will have worse longitudinal growth and protein catabolism. The investigators will also explore the secondary hypothesis that children with Crohn disease have abnormal IGF-1 generation which is linked to underlying inflammation and disease severity.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
1
Inclusion Criteria
  • Diagnosed with Crohn disease by endoscopy and histologic samples
  • Chronological and/or bone age 6-15 years old
  • Tanner 1 - 2
  • Willing to participate in our longitudinal evaluation
Exclusion Criteria
  • Concomitant persistent chronic infectious disease
  • Inflammatory bowel disease not diagnosed as Crohn disease
  • Immunological disorder (excluding Crohn disease)
  • Associated severe concomitant chronic illnesses (CF, liver failure)
  • Pregnancy

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
DiagnosticExaminations-
Primary Outcome Measures
NameTimeMethod
Height velocity6 months
Secondary Outcome Measures
NameTimeMethod
Protein catabolism6 months

Trial Locations

Locations (1)

Nationwide Children's Hospital

🇺🇸

Columbus, Ohio, United States

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