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

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

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohns Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Diagnostic

Examinations

Intervention Type OTHER

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

Interventions

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Examinations

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No