Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-02-24 @ 9:36 PM
Study NCT ID:
NCT02563834
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2015-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism
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': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D007328', 'term': 'Insulin'}], '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': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kmather@iu.edu', 'phone': '317-278-7826', 'title': 'Dr. Kieren J Mather', 'organization': 'Indiana University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Saline', 'description': 'Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).\n\nthiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms\n\nSaline: Saline infusion for control', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Insulin Clamp', 'description': 'Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).\n\nthiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms\n\nInsulin: Insulin infusion for insulin/glucose clamp procedure', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Myocardial Fatty Acid Uptake Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean Control - Saline', 'description': 'Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).\n\nthiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms\n\nSaline: Saline infusion for control'}, {'id': 'OG001', 'title': 'Lean Control - Insulin Clamp', 'description': 'Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).\n\nthiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms\n\nInsulin: Insulin infusion for insulin/glucose clamp procedure'}, {'id': 'OG002', 'title': 'Type 2 DM - Saline', 'description': 'Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).\n\nthiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms'}, {'id': 'OG003', 'title': 'Type 2 DM - Insulin Clamp', 'description': 'Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).\n\nthiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms'}], 'classes': [{'categories': [{'measurements': [{'value': '18.492', 'spread': '3.942', 'groupId': 'OG000'}, {'value': '2.123', 'spread': '1.087', 'groupId': 'OG001'}, {'value': '36.005', 'spread': '4.408', 'groupId': 'OG002'}, {'value': '7.8', 'spread': '1.215', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 Hours', 'description': 'PET measure of fatty acid uptake rate', 'unitOfMeasure': 'umol/min/100g', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Myocardial Oxidation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean Control - Saline', 'description': 'Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).\n\nthiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms\n\nSaline: Saline infusion for control'}, {'id': 'OG001', 'title': 'Lean Control - Insulin Clamp', 'description': 'Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).\n\nthiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms\n\nInsulin: Insulin infusion for insulin/glucose clamp procedure'}, {'id': 'OG002', 'title': 'Type 2 DM - Saline', 'description': 'Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).\n\nthiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms'}, {'id': 'OG003', 'title': 'Type 2 DM - Insulin Clamp', 'description': 'Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).\n\nthiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms'}], 'classes': [{'categories': [{'measurements': [{'value': '15.006', 'spread': '0.951', 'groupId': 'OG000'}, {'value': '19.847', 'spread': '1.773', 'groupId': 'OG001'}, {'value': '17.381', 'spread': '1.064', 'groupId': 'OG002'}, {'value': '22.940', 'spread': '2.288', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 Hours', 'description': 'PET measure of total oxidation rate', 'unitOfMeasure': 'ml/min/100g', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Myocardial Perfusion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean Control - Saline', 'description': 'Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).\n\nthiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms\n\nSaline: Saline infusion for control'}, {'id': 'OG001', 'title': 'Lean Control - Insulin Clamp', 'description': 'Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).\n\nthiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms\n\nInsulin: Insulin infusion for insulin/glucose clamp procedure'}, {'id': 'OG002', 'title': 'Type 2 DM - Saline', 'description': 'Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).\n\nthiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms'}, {'id': 'OG003', 'title': 'Type 2 DM - Insulin Clamp', 'description': 'Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).\n\nthiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms'}], 'classes': [{'categories': [{'measurements': [{'value': '39.3', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '46.5', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '44.2', 'spread': '2.3', 'groupId': 'OG002'}, {'value': '49.4', 'spread': '4.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 Hours', 'description': 'PET measure of total myocardial perfusion (blood flow)', 'unitOfMeasure': 'ml/min/100g', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lean Control', 'description': 'Studies will be performed on 2 separate days under fasting conditions, using a saline infusion on Day 1 and insulin infusion on Day 2. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate) on both study days.\n\nthiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms\n\nSaline: Saline infusion for control'}, {'id': 'FG001', 'title': 'Type 2 DM', 'description': 'Studies will be performed on 2 separate days under fasting conditions, using a saline infusion on Day 1 and insulin infusion on Day 2. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate) on both study days.\n\nthiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms'}], 'periods': [{'title': 'Control (Saline) Infusion (*Day 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Insulin Infusion (*Day 2)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lean Controls', 'description': 'Lean non-diabetic control participants, taking no regular medications.'}, {'id': 'BG001', 'title': 'Type 2 Diabetes', 'description': 'Participants with Type 2 diabetes treated with any combination of oral agents and insulin except PPARgamma agonists.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'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': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.1', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '40.4', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '36.9', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-30', 'studyFirstSubmitDate': '2015-09-29', 'resultsFirstSubmitDate': '2016-02-29', 'studyFirstSubmitQcDate': '2015-09-29', 'lastUpdatePostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-30', 'studyFirstPostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial Fatty Acid Uptake Rate', 'timeFrame': '4 Hours', 'description': 'PET measure of fatty acid uptake rate'}], 'secondaryOutcomes': [{'measure': 'Myocardial Oxidation Rate', 'timeFrame': '4 Hours', 'description': 'PET measure of total oxidation rate'}, {'measure': 'Myocardial Perfusion Rate', 'timeFrame': '4 Hours', 'description': 'PET measure of total myocardial perfusion (blood flow)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '26732686', 'type': 'RESULT', 'citation': 'Mather KJ, Hutchins GD, Perry K, Territo W, Chisholm R, Acton A, Glick-Wilson B, Considine RV, Moberly S, DeGrado TR. Assessment of myocardial metabolic flexibility and work efficiency in human type 2 diabetes using 16-[18F]fluoro-4-thiapalmitate, a novel PET fatty acid tracer. Am J Physiol Endocrinol Metab. 2016 Mar 15;310(6):E452-60. doi: 10.1152/ajpendo.00437.2015. Epub 2016 Jan 5.'}]}, 'descriptionModule': {'briefSummary': 'Studies of myocardial fuel selection using a novel palmitate-based PET probe', 'detailedDescription': 'A novel Positron Emission Tomography (PET) probe, 16- 18-F-fluoro-4-thiapalmitate, will be used to evaluate myocardial atty acid uptake. Studies will be done in humans with type 2 diabetes mellitus, and in controls. Studies will take place on 2 separate days, under fasting conditions and under insulin clamp conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lean:\n\n * BMI\\<25 kg/m2\n * normal glucose tolerance by 75g oral glucose tolerance test\n* Type 2 diabetes mellitus:\n\n * BMI \\>25 kg/m2\n * previously diagnosed type 2 diabetes mellitus\n * on oral and/or injected insulin treatment.\n\nExclusion Criteria:\n\n* Lean:\n\n \\*Use of any chronic medications\n* Type 2 diabetes mellitus\n\n * known microvascular disease\n * known coronary or other macro vascular disease\n * use of PPARgamma class antidiabetic agents within 6 months'}, 'identificationModule': {'nctId': 'NCT02563834', 'briefTitle': 'A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism', 'orgStudyIdInfo': {'id': '10100002643'}, 'secondaryIdInfos': [{'id': 'R21DK071142', 'link': 'https://reporter.nih.gov/quickSearch/R21DK071142', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saline', 'description': 'Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).', 'interventionNames': ['Drug: thiapalmitate tracer', 'Drug: Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Insulin Clamp', 'description': 'Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).', 'interventionNames': ['Drug: thiapalmitate tracer', 'Drug: Insulin']}], 'interventions': [{'name': 'thiapalmitate tracer', 'type': 'DRUG', 'otherNames': ['16- 18-F-fluoro-4-thiapalmitate'], 'description': 'Radiolabeled tracer infusion; occurs in all treatment arms', 'armGroupLabels': ['Insulin Clamp', 'Saline']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'Saline infusion for control', 'armGroupLabels': ['Saline']}, {'name': 'Insulin', 'type': 'DRUG', 'description': 'Insulin infusion for insulin/glucose clamp procedure', 'armGroupLabels': ['Insulin Clamp']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Hospital GCRC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Kieren J Mather, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}