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

NCT00946361 | Terminated

• 1 other identifier: IRB09-00036
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohns Disease

Outcome Measures

Primary Outcomes (1)

• Height velocity

  6 months

Secondary Outcomes (1)

• Protein catabolism

  6 months

Study Arms (1)

Diagnostic

Other: Examinations

Interventions

Examinations OTHER

Growth hormone stimulation testing, Protein turnover, Dexa scan, Bone age x-ray

Diagnostic

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

GI clinic patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Dana S Hardin, MD

  The Research Institute at Nationwide Children's Hospital, The Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2009
• First Posted: July 27, 2009
• Study Start: July 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 15, 2015

Record last verified: 2009-07

Locations

US (1)