Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-29 @ 10:04 AM
Study NCT ID:
NCT00374361
Status:
COMPLETED
Last Update Posted:
2016-06-08
First Post:
2006-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Relationship Between Blood Vessels and Insulin Response in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-06', 'studyFirstSubmitDate': '2006-09-07', 'studyFirstSubmitQcDate': '2006-09-08', 'lastUpdatePostDateStruct': {'date': '2016-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['insulin sensitivity', 'endothelial function', 'adolescence', 'lipids', 'puberty'], 'conditions': ['Diabetes Mellitus, Type 2', 'Hypertension', 'Heart Disease', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '18221434', 'type': 'RESULT', 'citation': 'Hoffman RP. Indices of insulin action calculated from fasting glucose and insulin reflect hepatic, not peripheral, insulin sensitivity in African-American and Caucasian adolescents. Pediatr Diabetes. 2008 Jun;9(3 Pt 2):57-61. doi: 10.1111/j.1399-5448.2007.00350.x. Epub 2008 Jan 21.'}, {'pmid': '17382119', 'type': 'RESULT', 'citation': 'Duck MM, Hoffman RP. Impaired endothelial function in healthy African-American adolescents compared with Caucasians. J Pediatr. 2007 Apr;150(4):400-6. doi: 10.1016/j.jpeds.2006.12.034.'}, {'pmid': '16732033', 'type': 'RESULT', 'citation': 'Hoffman RP. Increased fasting triglyceride levels are associated with hepatic insulin resistance in Caucasian but not African-American adolescents. Diabetes Care. 2006 Jun;29(6):1402-4. doi: 10.2337/dc06-2460. No abstract available.'}, {'pmid': '19288584', 'type': 'RESULT', 'citation': 'Xie L, Hoffman RP, Veng-Pedersen P. Noncompartmental pharmacokinetics analysis of glucose-stimulated insulin response in African-American and Caucasian youths. Biopharm Drug Dispos. 2009 Apr;30(3):117-25. doi: 10.1002/bdd.652.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to determine whether there is a relationship between the way insulin and blood vessels work. The difference in the interaction between Caucasian and African American adolescents will also be examined. This may play a role in the differing rates of heart disease and diabetes between the two groups.', 'detailedDescription': "Purpose: The purpose of the research is to learn more about how the lining of arteries in the body (called the endothelium) and insulin work in adolescents. Abnormalities in how the blood vessels and insulin work in adolescents may cause high blood pressure, type 2 diabetes, stroke and heart disease.\n\nHealthy adolescents between 8 and 18 years of age are being studied in the Ohio State University General Clinical Research Center. Two visits will be necessary. One will be a screening visit to determine the child's stage of puberty and obtain a medical history. The second will be the study visit. During the latter, blood vessel function will be determined by studying the change in forearm blood flow before and after blood flow to the forearm is stopped. Insulin sensitivity will be determined using glucose water given into a vein."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescents', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasian or African American adolescent\n* Between 8 and 18 years of age\n\nExclusion Criteria:\n\n* Pregnancy\n* Chronic Disease\n* Acute Disease\n* Medication Requirement'}, 'identificationModule': {'nctId': 'NCT00374361', 'briefTitle': 'Study of the Relationship Between Blood Vessels and Insulin Response in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Relationship of Endothelial Function to Insulin Sensitivity in African American and Caucasian Adolescents', 'orgStudyIdInfo': {'id': 'ENDO 203'}, 'secondaryIdInfos': [{'id': 'AHA 0355195B', 'type': 'OTHER_GRANT', 'domain': 'American Heart Association'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Caucasian Adolescents', 'description': 'Caucasian Adolescents'}, {'label': 'African-American Adolescents', 'description': 'African-American Adolescents'}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Robert P Hoffman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Observational'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': "Nationwide Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Robert Hoffman', 'investigatorAffiliation': 'Ohio State University'}}}}