Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-30 @ 2:26 PM
Study NCT ID:
NCT02020395
Status:
COMPLETED
Last Update Posted:
2013-12-24
First Post:
2013-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Test Meal on Satiation Hormones in Obese and Normal Weight Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-18', 'studyFirstSubmitDate': '2013-12-12', 'studyFirstSubmitQcDate': '2013-12-18', 'lastUpdatePostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of gastrointestinal peptide secretion in normal weight and obese adolescents', 'timeFrame': '2 hours blood sampling', 'description': 'Relation of GLP-1 release to insulin secretion in normal weight and obese adolescents'}], 'secondaryOutcomes': [{'measure': 'Association between gastrointestinal peptides and insulin release', 'timeFrame': '2 hours blood sampling', 'description': 'Dynamics of gastrointestinal peptide secretion including Tmax and Cmax'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Endocrine System Diseases']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to examine ghrelin, amylin, glucagon and glucagon-like peptide (GLP)-1 responses to a test meal in lean and obese individuals.', 'detailedDescription': 'The primary hypothesis is that obese adolescents have a disturbed balance of hormones associated with appetite regulation with less suppression of ghrelin and attenuated stimulation of GLP-1 secretion in response to meal intake compared to lean normal weight controls. A second aim of the study was to test which gastrointestinal peptides are most associated with insulin resistance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* caucasian youth\n* pubertal Tanner stage x, y, or z\n\nExclusion Criteria:\n\n* fasting plasma glucose \\> 7.0 mmol/L\n* significant illness\n* taking medications'}, 'identificationModule': {'nctId': 'NCT02020395', 'briefTitle': 'Effect of a Test Meal on Satiation Hormones in Obese and Normal Weight Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Effect of a Test Meal on Satiation Hormones in Obese and Normal Weight Adolescents', 'orgStudyIdInfo': {'id': 'GI peptides obese adolescents'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Test meal (500 kcal)_normal weight', 'description': 'ham sandwich chocolate cream orange juice', 'interventionNames': ['Dietary Supplement: test meal (500 kcal)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Test meal (500 kcal)_obese weight', 'description': 'ham sandwich chocolate cream orange juice', 'interventionNames': ['Dietary Supplement: test meal (500 kcal)']}], 'interventions': [{'name': 'test meal (500 kcal)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'whole wheat bread (68 g), butter(10 g), ham (25 g); chocolate cream (90 g); orange juice (200 mL)', 'armGroupLabels': ['Test meal (500 kcal)_normal weight']}, {'name': 'test meal (500 kcal)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'whole wheat bread (68 g), butter(10 g), ham (25 g); chocolate cream (90 g); orange juice (200 mL)', 'armGroupLabels': ['Test meal (500 kcal)_obese weight']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel, Division of Gastroenterology and Hepatology', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Christoph Beglinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Gastroenterology and Hepatology, University Hospital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': "University Children's Hospital Basel", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}