Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-07 @ 5:59 AM
Study NCT ID:
NCT00673894
Status:
COMPLETED
Last Update Posted:
2019-05-13
First Post:
2008-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Glutamine on GLP-1 and Insulin Secretion in Man
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'd.samochabonet@garvan.org.au', 'phone': '+61292958309', 'title': 'Dr. Dorit Samocha-Bonet', 'organization': 'Garvan Institute of Medical Research'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected during the 4 weeks treatment with the first arm and then during the 4 weeks of treatment with the second arm. Total of 8 weeks.', 'description': 'Adverse events were collected during physical visits to the Clinical Research Facility at the Garvan Institute of Medical Research. Participants were interviewed by the Study Nurse and asked to report any event or symptom they experienced during each of the 4 weeks treatments.', 'eventGroups': [{'id': 'EG000', 'title': 'Sitagliptin', 'description': 'Glutamine 30 g/d (15 g with breakfast and dinner) + Sitagliptin', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Glutamine 30 g/d (15 g with breakfast and dinner) + Placebo', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Postprandial Glucose Area Under the Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glutamine+Sitagliptin', 'description': 'Glutamine 30 g/d (15 g with breakfast and dinner) + Sitagliptin\n\nSitagliptin: Glutamine 30g +sitagliptin 100mg'}, {'id': 'OG001', 'title': 'Glutamine+Placebo', 'description': 'Glutamine 30 g/d (15 g with breakfast and dinner) + placebo\n\nPlacebo: Glutamine 30g +placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1341', 'spread': '180', 'groupId': 'OG000'}, {'value': '1463', 'spread': '179', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 180 minutes', 'description': 'The area under the curve (AUC) of the postprandial glucose following a meal challenge', 'unitOfMeasure': 'mmol/L*t', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary aim of this randomized crossover study was to determine the glycemic effect of 4 weeks of glutamine (15 bd) supplementation with sitagliptin (100 mg/d) or placebo in type 2 diabetes patients treated with metformin.'}, {'type': 'SECONDARY', 'title': 'Fructosamine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glutamine+Sitagliptin', 'description': 'Glutamine 30 g/d (15 g with breakfast and dinner) + Sitagliptin\n\nSitagliptin: Glutamine 30g +sitagliptin 100mg'}, {'id': 'OG001', 'title': 'Glutamine+Placebo', 'description': 'Glutamine 30 g/d (15 g with breakfast and dinner) + placebo\n\nPlacebo: Glutamine 30g +placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '244', 'spread': '41', 'groupId': 'OG000'}, {'value': '240', 'spread': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The blood concentration of the glycemic control marker fructosamine', 'unitOfMeasure': 'micro mol per litre', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The secondary aim of this randomized crossover study was to determine the glycemic effect of 4 weeks of glutamine (15 bd) supplementation with sitagliptin (100 mg/d) or placebo in type 2 diabetes patients treated with metformin.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitagliptin, Then Placebo', 'description': 'Participants first received Glutamine 30 g/d + Sitagliptin (100 mg/d) for 4 weeks. After a washout period of 4-6 weeks, they then received Glutamine 30 g/d + Placebo (matching Sitagliptin 100 mg) for 4 weeks'}, {'id': 'FG001', 'title': 'Placebo, Then Sitagliptin', 'description': 'Participants first received Glutamine 30 g/d + Placebo (matching Sitagliptin 100 mg) for 4 weeks. After a washout period of 4-6 weeks, they then received Glutamine 30 g/d + Sitagliptin (100 mg/d) for 4 weeks'}], 'periods': [{'title': 'First Intervention 4 Weeks', 'milestones': [{'type': 'STARTED', 'comment': 'First Intervention Duration 4 weeks', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout 4-6 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention 4 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '15 of 22 participants were randomized. Of those not randomized, 7 did not meet the inclusion criteria'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'First Received Sitagliptin, Then Placebo', 'description': 'Participants first received Glutamine 30 g/d + Sitagliptin (100 mg/d) for 4 weeks. After a washout period of 4-6 weeks, they then received Glutamine 30 g/d + Placebo (matching Sitagliptin 100 mg) for 4 weeks'}, {'id': 'BG001', 'title': 'First Received Placebo, Then Sitagliptin', 'description': 'Participants first received Glutamine 30 g/d + Placebo (matching Sitagliptin 100 mg/d) for 4 weeks. After a washout period of 4-6 weeks, they then received Glutamine 30 g/d +Sitagliptin (100 mg) for 4 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '2 individuals withdrew from the study'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64', 'spread': '8', 'groupId': 'BG000'}, {'value': '65', 'spread': '5', 'groupId': 'BG001'}, {'value': '65', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '2 individuals withdrew'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '2 individuals withdrew from the study'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': '2 participants withdrew'}], 'populationDescription': 'Participants who were randomized to receive either sitagliptin 100 mg tablet or placebo tablet (matching sitagliptin 100 mg)'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-11', 'studyFirstSubmitDate': '2008-05-06', 'resultsFirstSubmitDate': '2017-09-21', 'studyFirstSubmitQcDate': '2008-05-06', 'lastUpdatePostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-11', 'studyFirstPostDateStruct': {'date': '2008-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial Glucose Area Under the Curve (AUC)', 'timeFrame': '0 to 180 minutes', 'description': 'The area under the curve (AUC) of the postprandial glucose following a meal challenge'}], 'secondaryOutcomes': [{'measure': 'Fructosamine', 'timeFrame': '4 weeks', 'description': 'The blood concentration of the glycemic control marker fructosamine'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '21593352', 'type': 'RESULT', 'citation': 'Samocha-Bonet D, Wong O, Synnott EL, Piyaratna N, Douglas A, Gribble FM, Holst JJ, Chisholm DJ, Greenfield JR. Glutamine reduces postprandial glycemia and augments the glucagon-like peptide-1 response in type 2 diabetes patients. J Nutr. 2011 Jul;141(7):1233-8. doi: 10.3945/jn.111.139824. Epub 2011 May 18.'}, {'pmid': '25811109', 'type': 'RESULT', 'citation': 'Samocha-Bonet D, Chisholm DJ, Holst JJ, Greenfield JR. L-glutamine and whole protein restore first-phase insulin response and increase glucagon-like peptide-1 in type 2 diabetes patients. Nutrients. 2015 Mar 24;7(4):2101-8. doi: 10.3390/nu7042101.'}, {'pmid': '25412338', 'type': 'RESULT', 'citation': 'Samocha-Bonet D, Chisholm DJ, Gribble FM, Coster AC, Carpenter KH, Jones GR, Holst JJ, Greenfield JR. Glycemic effects and safety of L-Glutamine supplementation with or without sitagliptin in type 2 diabetes patients-a randomized study. PLoS One. 2014 Nov 20;9(11):e113366. doi: 10.1371/journal.pone.0113366. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'This study investigated the effect of glutamine, an amino acid, glycemia, glucagon-like peptide-1 (GLP-1) and insulin in participants with type 2 diabetes.', 'detailedDescription': 'In this study, we investigated the effect of glutamine, an amino acid, on glycemia and on GLP-1 and insulin in participants with type 2 diabetes. Preliminary data published by our group suggests that glutamine is a strong determinant of GLP-1 secretion in vitro. We tested the hypothesis that glutamine lowers postprandial blood glucose and investigated whether the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin modifies this effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes, on metformin or diet alone (not sulphonylureas or insulin)\n\nExclusion Criteria:\n\n* Malabsorption, renal or liver disease, treatment with steroids'}, 'identificationModule': {'nctId': 'NCT00673894', 'briefTitle': 'Effects of Glutamine on GLP-1 and Insulin Secretion in Man', 'organization': {'class': 'OTHER', 'fullName': 'Garvan Institute of Medical Research'}, 'officialTitle': 'Study of the Effects of Glutamine on Glycemia, Glucagon-like Peptide-1 (GLP-1) and Insulin Secretion in Man', 'orgStudyIdInfo': {'id': 'H07/059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glutamine+Sitagliptin', 'description': 'Glutamine 30 g/d (15 g with breakfast and dinner) + Sitagliptin', 'interventionNames': ['Drug: Sitagliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Glutamine+Placebo', 'description': 'Glutamine 30 g/d (15 g with breakfast and dinner) + placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sitagliptin', 'type': 'DRUG', 'otherNames': ['Januvia'], 'description': 'Glutamine 30g +sitagliptin 100mg', 'armGroupLabels': ['Glutamine+Sitagliptin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Glutamine 30g +placebo (matching sitagliptin 100 mg)', 'armGroupLabels': ['Glutamine+Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Clinical Research Facility', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'overallOfficials': [{'name': 'Jerry R Greenfield, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Garvan Institute of Medical Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Garvan Institute of Medical Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Dr Jerry Greenfield', 'investigatorAffiliation': 'Garvan Institute of Medical Research'}}}}