Clinical Trials Directory

Trials / Terminated

TerminatedNCT00946361

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

Impaired IGF-1 Generation Causes Protein Catabolism and Poor Growth in Children With Crohn Disease

Status
Terminated
Phase
Study type
Observational
Enrollment
1 (actual)
Sponsor
Nationwide Children's Hospital · Academic / Other
Sex
All
Age
5 Years – 15 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERExaminationsGrowth hormone stimulation testing, Protein turnover, Dexa scan, Bone age x-ray

Timeline

Start date
2009-07-01
Primary completion
2010-05-01
Completion
2010-05-01
First posted
2009-07-27
Last updated
2015-05-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00946361. Inclusion in this directory is not an endorsement.