Text Size

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

This study has been terminated.
(PI left institution)
Sponsor:
Information provided by:
Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT00946361
First received: July 24, 2009
Last updated: May 4, 2010
Last verified: July 2009
History of Changes

July 24, 2009
May 4, 2010
July 2009
March 2011   (final data collection date for primary outcome measure)
Height velocity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00946361 on ClinicalTrials.gov Archive Site
Protein catabolism [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

GI clinic patients
Crohns Disease
Other: Examinations
Growth hormone stimulation testing, Protein turnover, Dexa scan, Bone age x-ray
Diagnostic
Intervention: Other: Examinations
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
December 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
5 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00946361
IRB09-00036
No
Dana S. Hardin, MD, The Research Institute at Nationwide Children's Hospital
Nationwide Children's Hospital
Not Provided
Principal Investigator: Dana S Hardin, MD The Research Institute at Nationwide Children's Hospital, The Ohio State University
Nationwide Children's Hospital
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP