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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00946361
Enrollment
1
Registered
2009-07-27
Start date
2009-07-31
Completion date
2010-05-31
Last updated
2015-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohns Disease

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.

Interventions

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

Sponsors

Nationwide Children's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Height velocity6 months

Secondary

MeasureTime frame
Protein catabolism6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026