Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT00822705
Status:
COMPLETED
Last Update Posted:
2009-01-14
First Post:
2009-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inhibition of Food Intake in Response to Oral GLP-1 and Peptide YY3-36
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-13', 'studyFirstSubmitDate': '2009-01-13', 'studyFirstSubmitQcDate': '2009-01-13', 'lastUpdatePostDateStruct': {'date': '2009-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy consumption', 'timeFrame': '1 hour food consumption'}], 'secondaryOutcomes': [{'measure': 'Appetite feelings, plasma kinetics adverse events', 'timeFrame': 'adeverse events during study (3 months)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Appetite, energy consumption, gastrointestinal hormones'], 'conditions': ['Anti Obesity Agent']}, 'referencesModule': {'references': [{'pmid': '20720259', 'type': 'DERIVED', 'citation': 'Steinert RE, Poller B, Castelli MC, Drewe J, Beglinger C. Oral administration of glucagon-like peptide 1 or peptide YY 3-36 affects food intake in healthy male subjects. Am J Clin Nutr. 2010 Oct;92(4):810-7. doi: 10.3945/ajcn.2010.29663. Epub 2010 Aug 18.'}]}, 'descriptionModule': {'briefSummary': 'Interaction of GLP-1 and PYY3-36 in the inhibition of food intake in healthy subjects', 'detailedDescription': 'PYY3-36 and GLP-1 are two classical gastrointestinal peptides, which are released into the circulation during meals from L-cells of the distal gut; there is compelling evidence that each participates in the control of appetite regulating individual meal sizes in healthy subjects, but also in patients with obesity or diabetes type II. The regulation of human eating habits is, however, highly complex and our understanding of appetite control is far from complete. In many areas our knowledge is rather rudimentary; little is known, to give an example, about the importance of individual signals and their interactions.\n\nFrom studies in animals and humans it is known that individual satiety signals can interact: contributions of glucagon and CCK produced functionally synergistic inhibitions of feeding in rats, that is, simultaneous injection of the two peptides inhibited feeding significantly more than the sum of their individual effects. In contrast, we have been unable to show in healthy volunteers any interaction between GLP-1 and CCK33; the simultaneous infusion of CCK33 and GLP-1 resulted in an infra-additive reduction in meal size, which led us to suggest that the two peptides could even interact antagonistically.\n\nTo further explore potential interactions between these two well-known satiety signals, we plan to investigate the effects of individual doses of PYY3-36 and GLP-1, and their interaction in the control of food intake and satiety in healthy male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male subjects\n* no evidence of disease\n* no history of gastrointestinal or endocrine disorders\n\nExclusion Criteria:\n\n* alcohol and drug abuse\n* history of gastrointestinal or endocrine disorders\n* female subjects'}, 'identificationModule': {'nctId': 'NCT00822705', 'briefTitle': 'Inhibition of Food Intake in Response to Oral GLP-1 and Peptide YY3-36', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Inhibition of Food Intake in Response to Oral GLP-1 and Peptide YY3-36: a Phase 1 Study', 'orgStudyIdInfo': {'id': 'EKBB 127/07'}, 'secondaryIdInfos': [{'id': 'SNF grant 320000-118330'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ORAL GLP-1, TABLET', 'interventionNames': ['Drug: Placebo tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral PYY3-36', 'interventionNames': ['Drug: Placebo tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral GLP-1 plus oral PYY3-36', 'interventionNames': ['Drug: Placebo tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'interventionNames': ['Drug: Placebo tablet']}], 'interventions': [{'name': 'Placebo tablet', 'type': 'DRUG', 'description': 'Control arm', 'armGroupLabels': ['4', 'ORAL GLP-1, TABLET', 'Oral GLP-1 plus oral PYY3-36', 'Oral PYY3-36']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'Clinical Research Center, University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'CHRISTOPH BEGLINGER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Christoph Beglinger', 'oldOrganization': 'University Hospital, Basel, Switzerland'}}}}