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

Crohns Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00946361
• Other study ID #: IRB09-00036
• Status: Terminated
• Phase: N/A
• First received: July 24, 2009
• Last updated: May 14, 2015
• Start date: July 2009
• Est. completion date: May 2010

Study information

• Verified date: July 2009
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 15 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohns Disease

Intervention

Other:
• Examinations
Growth hormone stimulation testing, Protein turnover, Dexa scan, Bone age x-ray

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Height velocity		6 months	No
Secondary	Protein catabolism		6 months	No