Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-28 @ 8:41 PM
Study NCT ID:
NCT01366768
Status:
COMPLETED
Last Update Posted:
2012-10-10
First Post:
2011-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gut Hormones After Oral Versus Intravenous Amino Acids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-09', 'studyFirstSubmitDate': '2011-05-31', 'studyFirstSubmitQcDate': '2011-06-03', 'lastUpdatePostDateStruct': {'date': '2012-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gut hormone secretion', 'timeFrame': '300 min'}], 'secondaryOutcomes': [{'measure': 'Insulin secretion', 'timeFrame': '300 min'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gut hormones', 'Insulin secretion', 'Normal physiology'], 'conditions': ['Normal Non-fluency']}, 'descriptionModule': {'briefSummary': 'The study hypothesis is that gut hormones are released after oral but not intravenous amino acids which result in stimulation of insulin secretion.', 'detailedDescription': 'Amino acid mixture is given orally or intravenously to match total concentrations of amino acids in healthy subjects. Samples are taken regularly for 300 min after administrations. Plasma levels of the gut hormones glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1)and determined and related to plasma levels of insulin and glucagon.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects\n\nExclusion Criteria:\n\n* Diabetes\n* Liver disease\n* Kidney disease\n* Thyroid disease'}, 'identificationModule': {'nctId': 'NCT01366768', 'briefTitle': 'Gut Hormones After Oral Versus Intravenous Amino Acids', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'Release of Gut Hormones After Oral Versus Intravenous Amino Acids', 'orgStudyIdInfo': {'id': '003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral amino acid mixture', 'description': 'Oral administration of amino acid mixture in healthy volunteers', 'interventionNames': ['Other: Oral amino acid mixture']}, {'type': 'EXPERIMENTAL', 'label': 'Intravenous amino acid administration', 'description': 'Intravenous infusion of amino acid mixture in healthy volunteers', 'interventionNames': ['Other: Intravenous amino acid administration']}], 'interventions': [{'name': 'Oral amino acid mixture', 'type': 'OTHER', 'otherNames': ['Amino acid mixture'], 'description': 'Amino acid mixture 2,93 ml/kg', 'armGroupLabels': ['Oral amino acid mixture']}, {'name': 'Intravenous amino acid administration', 'type': 'OTHER', 'otherNames': ['Amino acid mixture'], 'description': 'Amino acid mixture 2,93 ml/kg', 'armGroupLabels': ['Intravenous amino acid administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '221 84', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Department of Clinical Sciences Lund, Lund University', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Bo Ahrén, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bo Ahren', 'investigatorAffiliation': 'Lund University'}}}}