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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
  Purpose

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.


Condition Intervention
Crohns Disease
 Other: Examinations

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impaired IGF-1 Generation Causes Protein Catabolism and Poor Growth in Children With Crohn Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Height velocity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Protein catabolism [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: July 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Diagnostic Other: Examinations
Growth hormone stimulation testing, Protein turnover, Dexa scan, Bone age x-ray

  Eligibility

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

GI clinic patients

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946361

Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Dana S Hardin, MD The Research Institute at Nationwide Children's Hospital, The Ohio State University
  More Information

No publications provided

Responsible Party: Dana S. Hardin, MD, The Research Institute at Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00946361     History of Changes
Other Study ID Numbers: IRB09-00036
Study First Received: July 24, 2009
Last Updated: May 4, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 23, 2013