Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
Study NCT ID:
NCT01176760
Status:
UNKNOWN
Last Update Posted:
2012-12-07
First Post:
2010-08-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intact Vagal Innervation for and Glucagon-like Peptide-1 (GLP-1) Effects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018819', 'term': 'Dipeptidyl Peptidase 4'}, {'id': 'D000077597', 'term': 'Vildagliptin'}, {'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D004152', 'term': 'Dipeptidyl-Peptidases and Tripeptidyl-Peptidases'}, {'id': 'D020689', 'term': 'Exopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D000945', 'term': 'Antigens, Differentiation, T-Lymphocyte'}, {'id': 'D000943', 'term': 'Antigens, Differentiation'}, {'id': 'D000954', 'term': 'Antigens, Surface'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D015415', 'term': 'Biomarkers'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-06', 'studyFirstSubmitDate': '2010-08-05', 'studyFirstSubmitQcDate': '2010-08-05', 'lastUpdatePostDateStruct': {'date': '2012-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'insulin secretion', 'timeFrame': 'four hours', 'description': 'The insulin secretion during a four-hour oral glucose tolerance test (OGTT) and an intravenous isoglycaemic clamp is evaluated'}], 'secondaryOutcomes': [{'measure': 'plasma GLP-1', 'timeFrame': '12 time points within four hours', 'description': '12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour'}, {'measure': 'plasma GIP', 'timeFrame': '12 time points within four hours', 'description': '12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour'}, {'measure': 'plasma glucagon', 'timeFrame': '12 time points within four hours', 'description': '12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour'}, {'measure': 'plasma GLP-2', 'timeFrame': '12 time points within four hours', 'description': '12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour'}, {'measure': 'plasma PYY', 'timeFrame': '12 time points within four hours', 'description': '12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vagotomy', 'vagus', 'GLP-1', 'Insulin secretion'], 'conditions': ['Vagotomy, Truncal']}, 'referencesModule': {'references': [{'pmid': '23704713', 'type': 'DERIVED', 'citation': 'Plamboeck A, Veedfald S, Deacon CF, Hartmann B, Wettergren A, Svendsen LB, Meisner S, Hovendal C, Knop FK, Vilsboll T, Holst JJ. Characterisation of oral and i.v. glucose handling in truncally vagotomised subjects with pyloroplasty. Eur J Endocrinol. 2013 Jul 6;169(2):187-201. doi: 10.1530/EJE-13-0264. Print 2013 Aug.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the role of transmission via the vagal nerve for the effect of glucose and Glucagon-like peptide-1 (GLP-1) in respect to insulin secretion.\n\nThe hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous system and for this reason the investigators will research individuals with and without intact nervous supply.', 'detailedDescription': 'GLP-1 is a potent enterogastron and incretin hormone. It is rapidly inactivated by dipeptidyl peptidase IV so only 10-15% enters the systemic circulation. This has led to the hypothesis that GLP-1 interact locally with afferent sensory nerve fibers. We investigated the role of intact vagal innervations on the effect of glucose and GLP-1 on the insulin secretion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* normal fasting plasma glucose\n* normal hemoglobin\n* informed consent\n\nExclusion Criteria:\n\n* type 1 diabetes mellitus or type 2 diabetes mellitus\n* body mass index \\> 30\n* inflammatory bowel disease\n* intestinal surgery\n* serum creatinine \\> 250 µM and/or albuminuria\n* ALAT \\> 2 x normal value\n* Severe cardiac insufficiency\n* in treatment with medicine which cannot be paused for 12 hours'}, 'identificationModule': {'nctId': 'NCT01176760', 'briefTitle': 'Intact Vagal Innervation for and Glucagon-like Peptide-1 (GLP-1) Effects', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'The Significances of Intact Vagal Innervation for the Glucose and GLP1 Induced Insulin Secretion', 'orgStudyIdInfo': {'id': 'Truncated isoglycemia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vago', 'description': 'Truncally vagotomized subjects (due to duodenal ulcer operation)', 'interventionNames': ['Drug: Dipeptidyl peptidase 4 (DPP 4) inhibitor', 'Other: oral glucose']}, {'type': 'EXPERIMENTAL', 'label': 'Cardia', 'description': 'Truncally vagotomized subjects (due to cardia resection)', 'interventionNames': ['Drug: Dipeptidyl peptidase 4 (DPP 4) inhibitor', 'Other: oral glucose']}, {'type': 'EXPERIMENTAL', 'label': 'Ctrl', 'description': 'Healthy matched control subjects', 'interventionNames': ['Drug: Dipeptidyl peptidase 4 (DPP 4) inhibitor', 'Other: oral glucose']}], 'interventions': [{'name': 'Dipeptidyl peptidase 4 (DPP 4) inhibitor', 'type': 'DRUG', 'otherNames': ['Galvus'], 'description': 'One tablet (50 mg)of DPP4 inhibitor is to be taken 12 and 1 hours before start of the oral glucose tolerance test (50 g glucose and 1.5 g paracetamol dissolved in 300 ml water)on day 3', 'armGroupLabels': ['Cardia', 'Ctrl', 'Vago']}, {'name': 'oral glucose', 'type': 'OTHER', 'otherNames': ['panodil'], 'description': '50 g glucose dissolved in 300 ml water with 1,5 g paracetamol is to be ingested orally within the first 15 minutes.', 'armGroupLabels': ['Cardia', 'Ctrl', 'Vago']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of internal medicine F´laboratory, Gentofte Hospital', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}], 'overallOfficials': [{'name': 'Astrid Plamboeck, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Gentofte, Copenhagen'}, {'name': 'Tina Vilsbøll, MD, dr.med', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Gentofte, Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jonatan I Bagger', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}