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

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ClinicalTrials.gov Identifier: NCT00946361
Recruitment Status : Terminated (PI left institution)
First Posted : July 27, 2009
Last Update Posted : May 15, 2015
Sponsor:
Information provided by (Responsible Party):
Nationwide Children's Hospital

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.


Condition or disease Intervention/treatment
Crohns Disease Other: Examinations

Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impaired IGF-1 Generation Causes Protein Catabolism and Poor Growth in Children With Crohn Disease
Study Start Date : July 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Group/Cohort Intervention/treatment
Diagnostic Other: Examinations
Growth hormone stimulation testing, Protein turnover, Dexa scan, Bone age x-ray



Primary Outcome Measures :
  1. Height velocity [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Protein catabolism [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00946361     History of Changes
Other Study ID Numbers: IRB09-00036
First Posted: July 27, 2009    Key Record Dates
Last Update Posted: May 15, 2015
Last Verified: July 2009

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Mecasermin
Growth Substances
Physiological Effects of Drugs