Ignite Creation Date:
2025-12-25 @ 4:45 AM
Ignite Modification Date:
2026-03-02 @ 10:56 PM
Study NCT ID:
NCT04466618
Status:
COMPLETED
Last Update Posted:
2023-12-26
First Post:
2020-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Endogenous GLP-1 Secretion on Islet Function in People With and Without Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}}}}, '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': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'C545823', 'term': 'soybean oil, phospholipid emulsion'}, {'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vella.adrian@mayo.edu', 'phone': '5072843754', 'title': 'Dr Adrian Vella', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The 3 months of participation', 'eventGroups': [{'id': 'EG000', 'title': 'Non-diabetic Subjects Saline', 'description': 'Subjects without Diabetes and Saline infused.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-diabetic Subjects Exendin-9,39', 'description': 'Subjects without Diabetes and Exendin-9,39 infused.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Non-diabetic Subjects Saline + Intralipid/Heparin', 'description': 'Subjects without Diabetes and Saline + Intralipid/Heparin infused.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Non-diabetic Subjects Exendin-9,39 + Intralipid/Heparin:', 'description': 'Subjects without Diabetes and Exendin-9,39 + Intralipid/Heparin infused.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Type 2 Diabetes Saline', 'description': 'Subjects with Type 2 Diabetes and Saline infused.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Type 2 Diabetes Exendin-9,39', 'description': 'Subjects with Type 2 Diabetes and Exendin-9,39 infused.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hyperglycemia', 'notes': 'one patient presented with hyperglycemia on the morning of the study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'IV access loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Fasting Glucagon in the Presence or Absence of Exendin-9,39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Diabetes', 'description': 'Subjects without Diabetes'}, {'id': 'OG001', 'title': 'Type 2 Diabetes', 'description': 'Subjects with Type 2 Diabetes'}], 'classes': [{'title': 'Saline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Exendin 9-39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average concentration over the -30 to 0 minutes of study', 'description': 'Concentrations of glucagon Measured by immunoassay over the -30 to 0 minutes of study.\n\nOn one study day subjects received saline, on the other exendin-9,39. The infusion commenced at -120 minutes.', 'unitOfMeasure': 'pmol/l', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient with type 2 diabetes did not complete one study secondary to loss of IV access'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Non-diabetic Subjects', 'description': 'Saline: Saline infused during the study\n\nExendin-9,39: Exendin-9,39 infused during the study\n\nIn a subset an additional 2 arms: -\n\nSaline + Intralipid/Heparin: Saline infused during acute insulin resistance\n\nExendin-9,39 + Intralipid/Heparin: Exendin-9,39 infused during acute insulin resistance'}, {'id': 'FG001', 'title': 'Subjects With Type 2 Diabetes', 'description': 'Saline: Saline infused during the study\n\nExendin-9,39: Exendin-9,39 infused during the study'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'No Diabetes', 'description': 'Subjects without Diabetes'}, {'id': 'BG001', 'title': 'Type 2 Diabetes', 'description': 'Subjects with Type 2 Diabetes'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54', 'spread': '8', 'groupId': 'BG000'}, {'value': '58', 'spread': '5', 'groupId': 'BG001'}, {'value': '56', 'spread': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-10', 'size': 1082627, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-03T15:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2020-06-30', 'resultsFirstSubmitDate': '2023-11-03', 'studyFirstSubmitQcDate': '2020-07-07', 'lastUpdatePostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-07', 'studyFirstPostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Fasting Glucagon in the Presence or Absence of Exendin-9,39', 'timeFrame': 'Average concentration over the -30 to 0 minutes of study', 'description': 'Concentrations of glucagon Measured by immunoassay over the -30 to 0 minutes of study.\n\nOn one study day subjects received saline, on the other exendin-9,39. The infusion commenced at -120 minutes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '37751301', 'type': 'DERIVED', 'citation': 'Welch AA, Farahani RA, Egan AM, Laurenti MC, Zeini M, Vella M, Bailey KR, Cobelli C, Dalla Man C, Matveyenko A, Vella A. Glucagon-like peptide-1 receptor blockade impairs islet secretion and glucose metabolism in humans. J Clin Invest. 2023 Nov 15;133(22):e173495. doi: 10.1172/JCI173495.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': "GLP-1 is a hormone made by the body that promotes the production of insulin in response to GLP-1 is produced within the islets expressing prohormone convertase 1/3eating. However, there is increasing evidence that this hormone might help support the body's ability to produce insulin when diabetes develops. The purpose of this study is to determine the effect of endogenous GLP-1 secretion on insulin secretion in people with and without type 2 diabetes.", 'detailedDescription': "Accumulating evidence suggests that in rodents and humans GLP-1 is synthesized within islets and may act locally in a paracrine fashion. Indeed, mice with genetic loss of intra-islet GLP-1 exhibit decreased insulin secretion and impaired response to metabolic stressors. 'Pancreatic' GLP-1 may contribute to the effects of DPP-4 inhibitors in rodents and humans. Antagonism of GLP1R with exendin-9,39 during fasting impairs the islet cell response to an I.V. glucose challenge. Islet GLP-1 content is increased in T2DM and in islets from non-diabetic humans exposed to hyperglycemia and Free Fatty Acids. These observations imply that paracrine GLP-1 secretion supports islet function in the presence of glucolipotoxicity. In this experiment we will examine the role of endogenous GLP-1 secretion in people with and without T2DM and during β-cell stress induced by FFA elevation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria - non-diabetic subjects:\n\n* Weight-stable, non-diabetic subjects\n\nExclusion Criteria - non-diabetic subjects:\n\n* Age \\< 25 or \\> 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).\n* HbA1c ≥ 6.5%\n* Use of glucose-lowering agents.\n* For female subjects: positive pregnancy test at the time of enrollment or study\n* History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.\n* Active systemic illness or malignancy.\n* Symptomatic macrovascular or microvascular disease.\n\nInclusion criteria - diabetic subjects:\n\n* Weight-stable, diabetic subjects treated with diet and lifestyle alone or with metformin monotherapy\n\nExclusion Criteria - diabetic subjects:\n\n* Age \\< 25 or \\> 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).\n* Use of any glucose-lowering agent other than metformin.\n* 2 or more fasting glucose values \\> 250mg/dl on medication or after medication withdrawal.\n* Unwillingness or inability to withdraw medication for three weeks prior to, and for the duration of the study.\n* For female subjects: positive pregnancy test at the time of enrollment or study\n* History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.\n* Active systemic illness or malignancy.\n* Symptomatic macrovascular or microvascular disease.'}, 'identificationModule': {'nctId': 'NCT04466618', 'briefTitle': 'Endogenous GLP-1 Secretion on Islet Function in People With and Without Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'To Determine the Effect of Endogenous GLP-1 Secretion on Islet Function in People With and Without Type 2 Diabetes', 'orgStudyIdInfo': {'id': '20-003993'}, 'secondaryIdInfos': [{'id': 'R01DK126206', 'link': 'https://reporter.nih.gov/quickSearch/R01DK126206', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Saline infusion', 'interventionNames': ['Biological: Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exendin-9,39', 'description': 'Exendin-9,39 infusion', 'interventionNames': ['Biological: Exendin-9,39']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Saline + Intralipid/Heparin', 'description': 'Induction of acute insulin resistance during Saline infusion', 'interventionNames': ['Biological: Saline + Intralipid/Heparin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exendin-9,39 + Intralipid/Heparin', 'description': 'Induction of acute insulin resistance during Exendin-9,39 infusion', 'interventionNames': ['Biological: Exendin-9,39 + Intralipid/Heparin']}], 'interventions': [{'name': 'Saline', 'type': 'BIOLOGICAL', 'description': 'Saline infused during the study', 'armGroupLabels': ['Saline']}, {'name': 'Exendin-9,39', 'type': 'BIOLOGICAL', 'description': 'Exendin-9,39 infused during the study', 'armGroupLabels': ['Exendin-9,39']}, {'name': 'Saline + Intralipid/Heparin', 'type': 'BIOLOGICAL', 'description': 'Saline infused during acute insulin resistance', 'armGroupLabels': ['Saline + Intralipid/Heparin']}, {'name': 'Exendin-9,39 + Intralipid/Heparin', 'type': 'BIOLOGICAL', 'description': 'Exendin-9,39 infused during acute insulin resistance', 'armGroupLabels': ['Exendin-9,39 + Intralipid/Heparin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Adrian Vella', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adrian Vella', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Adrian Vella', 'investigatorAffiliation': 'Mayo Clinic'}}}}