Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-03-09 @ 7:26 PM
Study NCT ID:
NCT01750333
Status:
UNKNOWN
Last Update Posted:
2012-12-17
First Post:
2012-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Correlation Between Vascular ET-1 and Adiponectin in Pediatric Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-04-11', 'releaseDate': '2016-03-14'}], 'estimatedResultsFirstSubmitDate': '2016-03-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '* serum\n* plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-12', 'studyFirstSubmitDate': '2012-12-12', 'studyFirstSubmitQcDate': '2012-12-12', 'lastUpdatePostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between serum levels of ET-1 and Ad in lean, overweight and obese children', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['OBESITY', 'Endothelial Dysfunction', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to explore whether and how high circulating levels of endothelin-1 (ET-1) in obese and overweight children may contribute to impair adiponectin (Ad) production, release and vascular activity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'CHILDREN ATTENDING THE OUTPATIENT UNIT OF THE UNIVERSITY PEDIATRIC CLINIC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children will be enrolled into lean, overweight or obese groups based on Body mass index (BMI) calculated according to standard methods. International standards for sex-and age-specific BMI centiles for subjects aged 2-18 years will be used. The 95th centile of BMI reference is the cut off point for childhood obesity. Overweight and obese children are defined as those with a BMI higher than the centile curves.\n\nExclusion Criteria:\n\n* presence of renal, liver and/or cardiovascular diseases;\n* hypertension;\n* metabolic and/or endocrine disorders;\n* genetic syndromes;\n* histories of chronic allergies, acute infectious or inflammatory diseases during the last 3 months preceding the study'}, 'identificationModule': {'nctId': 'NCT01750333', 'briefTitle': 'Study on Correlation Between Vascular ET-1 and Adiponectin in Pediatric Obesity', 'organization': {'class': 'INDIV', 'fullName': 'Montagnani, Monica, M.D., Ph.D.'}, 'officialTitle': 'Observational Retrospective Study on Correlation Between ET-1 and Ad in Obese Children', 'orgStudyIdInfo': {'id': 'OBETAD-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lean children'}, {'label': 'Overweight Children (OW)'}, {'label': 'Obese children (Ob)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'University of Bari Medical School - Dept Biomedical Sciences and Human Oncology', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}], 'overallOfficials': [{'name': 'Monica Montagnani, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bari Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monica Montagnani', 'class': 'INDIV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical School Faculty Member - Professor of Pharmacology', 'investigatorFullName': 'Monica Montagnani', 'investigatorAffiliation': 'Montagnani, Monica, M.D., Ph.D.'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-03-14', 'type': 'RELEASE'}, {'date': '2016-04-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Monica Montagnani, Medical School Faculty Member - Professor of Pharmacology, Montagnani, Monica, M.D., Ph.D.'}}}}