Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT00000112
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of Carbohydrate Intolerance in Lean and Obese Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D000052', 'term': 'Acanthosis Nigricans'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D008548', 'term': 'Melanosis'}, {'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'DEFINED_POPULATION'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-12', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2000-01-18', 'studyFirstSubmitQcDate': '2000-01-18', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-01-19', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Obesity', 'Glucose Intolerance', 'Diabetes', 'Acanthosis Nigricans']}, 'referencesModule': {'references': [{'pmid': '36469736', 'type': 'DERIVED', 'citation': 'Halloun R, Galderisi A, Caprio S, Weiss R. Adipose Tissue Insulin Resistance Is Not Associated With Changes in the Degree of Obesity in Children and Adolescents. J Clin Endocrinol Metab. 2023 Apr 13;108(5):1053-1060. doi: 10.1210/clinem/dgac700.'}, {'pmid': '35235641', 'type': 'DERIVED', 'citation': 'Halloun R, Galderisi A, Caprio S, Weiss R. Lack of Evidence for a Causal Role of Hyperinsulinemia in the Progression of Obesity in Children and Adolescents: A Longitudinal Study. Diabetes Care. 2022 Jun 2;45(6):1400-1407. doi: 10.2337/dc21-2210.'}, {'pmid': '31421157', 'type': 'DERIVED', 'citation': 'Ricke J, Klumpen HJ, Amthauer H, Bargellini I, Bartenstein P, de Toni EN, Gasbarrini A, Pech M, Peck-Radosavljevic M, Popovic P, Rosmorduc O, Schott E, Seidensticker M, Verslype C, Sangro B, Malfertheiner P. Impact of combined selective internal radiation therapy and sorafenib on survival in advanced hepatocellular carcinoma. J Hepatol. 2019 Dec;71(6):1164-1174. doi: 10.1016/j.jhep.2019.08.006. Epub 2019 Aug 14.'}]}, 'descriptionModule': {'briefSummary': 'The prevalence of obesity in children is reaching epidemic proportions. Excess adiposity is more than just a cosmetic problem, having substantial metabolic consequences. Insulin resistance, hyperinsulinemia, impaired glucose tolerance, and frank diabetes are often seen in obese children. In this study the prevalence of impaired glucose (carbohydrate) tolerance in lean children with a family history of diabetes and obese children with acanthosis nigricans with or without a family history of diabetes mellitus will be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obesity: BM +/- 95% for age general good health'}, 'identificationModule': {'nctId': 'NCT00000112', 'briefTitle': 'Prevalence of Carbohydrate Intolerance in Lean and Obese Children', 'organization': {'class': 'NIH', 'fullName': 'National Center for Research Resources (NCRR)'}, 'orgStudyIdInfo': {'id': 'NCRR-M01RR06022-0029'}, 'secondaryIdInfos': [{'id': 'M01RR006022', 'link': 'https://reporter.nih.gov/quickSearch/M01RR006022', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520-8064', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Yale University School of Medicine, Pediatric Endocrinology', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'centralContacts': [{'name': 'Sonia Caprio, M.D.', 'role': 'CONTACT', 'email': 'sonia.caprio@yale.edu', 'phone': '1-203-764-5692'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}}}}