Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-31 @ 6:25 AM
Study NCT ID:
NCT00946361
Status:
TERMINATED
Last Update Posted:
2015-05-15
First Post:
2009-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impaired Insulin-like Growth Factor-1 (IGF-1) Generation Causes Protein Catabolism and Poor Growth in Children With Crohn Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'PI left institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-14', 'studyFirstSubmitDate': '2009-07-24', 'studyFirstSubmitQcDate': '2009-07-24', 'lastUpdatePostDateStruct': {'date': '2015-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Height velocity', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Protein catabolism', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Crohns Disease']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'GI clinic patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Crohn disease by endoscopy and histologic samples\n* Chronological and/or bone age 6-15 years old\n* Tanner 1 - 2\n* Willing to participate in our longitudinal evaluation\n\nExclusion Criteria:\n\n* Concomitant persistent chronic infectious disease\n* Inflammatory bowel disease not diagnosed as Crohn disease\n* Immunological disorder (excluding Crohn disease)\n* Associated severe concomitant chronic illnesses (CF, liver failure)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00946361', 'briefTitle': 'Impaired Insulin-like Growth Factor-1 (IGF-1) Generation Causes Protein Catabolism and Poor Growth in Children With Crohn Disease', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Impaired IGF-1 Generation Causes Protein Catabolism and Poor Growth in Children With Crohn Disease', 'orgStudyIdInfo': {'id': 'IRB09-00036'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diagnostic', 'interventionNames': ['Other: Examinations']}], 'interventions': [{'name': 'Examinations', 'type': 'OTHER', 'description': 'Growth hormone stimulation testing, Protein turnover, Dexa scan, Bone age x-ray', 'armGroupLabels': ['Diagnostic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Dana S Hardin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Research Institute at Nationwide Children's Hospital, The Ohio State University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}