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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:
ClinicalTrials.gov Identifier:
NCT00946361
First Posted: July 27, 2009
Last Update Posted: May 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nationwide Children's Hospital
  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:


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

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

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

Enrollment: 1
Study Start Date: July 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (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

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
  Contacts and Locations
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
  More Information

Responsible Party: Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00946361     History of Changes
Other Study ID Numbers: IRB09-00036
First Submitted: July 24, 2009
First Posted: July 27, 2009
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