Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-01-03 @ 9:34 PM
Study NCT ID:
NCT02493959
Status:
COMPLETED
Last Update Posted:
2015-07-10
First Post:
2015-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Degradation of the Anorexic Hormone Peptide YY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018761', 'term': 'Multiple Endocrine Neoplasia Type 1'}], 'ancestors': [{'id': 'D009377', 'term': 'Multiple Endocrine Neoplasia'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009378', 'term': 'Neoplasms, Multiple Primary'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-09', 'studyFirstSubmitDate': '2015-07-02', 'studyFirstSubmitQcDate': '2015-07-09', 'lastUpdatePostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Appetite and nausea scores', 'timeFrame': '0-240 min', 'description': 'Between infusion differences in VAS scores'}, {'measure': 'Blood pressure', 'timeFrame': '0-240 min', 'description': 'Between infusion differences in blood pressure'}, {'measure': 'Blood glucose', 'timeFrame': '0-240 min', 'description': 'Between infusion differences in blood glucose'}, {'measure': 'Heart rate', 'timeFrame': '0-240 min', 'description': 'Between infusion differences in heart rate'}], 'primaryOutcomes': [{'measure': 'PYY3-34 concentration', 'timeFrame': '0-240 min'}, {'measure': 'Half-lives of PYY1-36 and PYY3-36', 'timeFrame': '0-240 min'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PYY', 'Degradation', 'kinetics', 'men'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Peptide YY (PYY) is a gastrointestinal hormone released from the enteroendocrine cell upon food intake. The N-terminal truncated form, PYY3-36, exerts anorexic effects. In this study we want to investigate the kinetics of PYY1-36 and PYY3-36 and to examine whether a C-terminally degraded metabolite, PYY3-34, is formed after infusion of PYY.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Normal BMI (18.5-25kg/m2)\n\nExclusion Criteria:\n\n* Diabetes Mellitus\n* Gastric bypass\n* Non-caucasian\n* Height changes \\>3 kg within last two months\n* Hemoglobin \\< 7.6 mmol/l\n* Chronic disease\n* Smoking\n* Regularly use of medicine\n* Drug abuse'}, 'identificationModule': {'nctId': 'NCT02493959', 'briefTitle': 'Degradation of the Anorexic Hormone Peptide YY', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Degradation of the Anorexic Hormone Peptide YY', 'orgStudyIdInfo': {'id': 'STKBM-PI14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PYY infusion', 'description': 'IV infusion on 4 separate days of PYY or saline in Healthy, normal-weight men, age 18-50 years', 'interventionNames': ['Biological: PYY1-36 infusion', 'Biological: PYY1-36 + sitagliptin', 'Biological: PYY3-36 infusion', 'Biological: placebo']}], 'interventions': [{'name': 'PYY1-36 infusion', 'type': 'BIOLOGICAL', 'description': 'Infusion of 1.6 pmol/kg/min PYY1-36 for 2 hrs.', 'armGroupLabels': ['PYY infusion']}, {'name': 'PYY1-36 + sitagliptin', 'type': 'BIOLOGICAL', 'description': 'Infusion of 1.6 pmol/kg/min PYY1-36 for 2 hrs. Two doses of 100 mg sitagliptin are administered 10 and 1 hour before start of infusion, respectively.', 'armGroupLabels': ['PYY infusion']}, {'name': 'PYY3-36 infusion', 'type': 'BIOLOGICAL', 'description': '0.8 pmol/kg/min infusion of PYY3-36.', 'armGroupLabels': ['PYY infusion']}, {'name': 'placebo', 'type': 'BIOLOGICAL', 'description': 'Infusion of saline for 2 hrs.', 'armGroupLabels': ['PYY infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Department of Endocrinology, Hvidovre Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Kirstine Nyvold Bojsen-Moeller', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}