Impaired Insulin-like Growth Factor-1 (IGF-1) Generation Causes Protein Catabolism and Poor Growth in Children With Crohn Disease
Stopped early
Conditions studied: Crohns Disease
In brief
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.
Key facts
- Study ID
- NCT00946361
- Run by
- Nationwide Children's Hospital
- People needed
- 1
- Starts
- 2009-07-01
- Expected to finish
- 2010-05-01
- Last updated by the study team
- 2015-05-15
Who can join
Age: 5 and older, up to 15. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Nationwide Children's Hospital — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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