Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:48 AM
Study NCT ID:
NCT01588418
Status:
COMPLETED
Last Update Posted:
2017-11-24
First Post:
2012-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Acute Effect of Exenatide on Brain Glucose Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'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': 'D000077270', 'term': 'Exenatide'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'defronzo@uthscsa.edu', 'phone': '210-567-6691', 'title': 'Dr. Ralph DeFronzo', 'organization': 'University of Texas Health Science Center at San Antonio'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Our study has several potential limitations. It included only men. During OGTT it is difficult to evaluate the separate contributions of glucose and insulin.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PET With Exenatide or Placebo Injection', 'description': 'This is a crossover study where all subjects received the same intervention with Exenatide and placebo, acutely in random order, (i.e. first or second before OGTT-PET study).', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Effect of Exenatide or Placebo on CMRglu', 'description': 'Brain glucose metabolism (CMRglu) during OGTT measured by PET w/ or w/out Exenatide injection'}], 'classes': [{'title': 'total gray matter CMRglu after Exenatide', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.02', 'groupId': 'OG000'}]}]}, {'title': 'total gray matter CMRglu after Placebo', 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.01', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '120 minutes after exenatide or placebo injection', 'description': 'To study the acute effect of exenatide on brain glucose metabolism after the glucose load. Brain glucose uptake will be determined from serial FDG PET-imaging, by using graphical methods to quantify both global and regional results. The results obtained after Exenatide injection will be compared with the ones obtained after injection of placebo in the same subject.', 'unitOfMeasure': 'μmol/(ml*min)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'We studied, in the same subject, the acute effect of injection of exenatide vs placebo on brain glucose metabolism (CMRglu) after the glucose load. We used FDG PET-imaging to quantify global and regional results.'}, {'type': 'SECONDARY', 'title': 'Effect of Exenatide on the Liver and Adipose Tissue Glucose Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide First, Then Placebo', 'description': 'Exenatide 5mcg was injected subcutaneously 30 min before Oral Glucose Tolerance Test (OGTT)-PET study. The same subject was studied again a few weeks later with the same protocol with Placebo injection.\n\nExenatide: Exenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study\n\nPlacebo: Placebo was administered in random order 30 min before OGTT-PET study in the same subject'}, {'id': 'OG001', 'title': 'Placebo First, Then Exenatide', 'description': 'Placebo was injected subcutaneously 30 min before OGTT-PET study. The same subject was studied again a few weeks later with the same protocol with injection of Exenatide 5mcg .\n\nExenatide: Exenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study\n\nPlacebo: Placebo was administered in random order 30 min before OGTT-PET study in the same subject'}], 'timeFrame': '60 minutes after exenatide or placebo injection', 'description': 'we evaluated the acute effects of exenatide on hepatic (Hep-IR) and adipose (Adipo-IR) insulin resistance and glucose uptake.', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome data was not collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OGTT-PET: Exenatide First Then Placebo', 'description': 'In the first study subjects received exenatide 5ug injected before OGTT-PET. In the second study (3 to 12 wk after first study), subjects received placebo injection before OGTT-PET'}, {'id': 'FG001', 'title': 'OGTT-PET: Placebo First, Then Exenatide', 'description': 'In the first study subjects received placebo injected before OGTT-PET. In the second study (3 to 12 wk after first study), subjects received exenatide injection (5ug) before OGTT-PET'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PET With Exenatide vs Placebo Injection', 'description': 'All subjects will receive the same intervention with Exenatide and placebo. Exenatide or placebo will be administered in random order, (i.e. first or second before OGTT-PET study).\n\nIn the first study IGT male subjects will be randomized to exenatide or placebo injection before OGTT-PET study. In the second study the same subjects will receive placebo or exenatide respectively before OGTT-PET study. The results obtained after Exenatide injection will be compared with the ones obtained after injection of placebo in the same subject.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI (Body Mass Index)', 'classes': [{'categories': [{'measurements': [{'value': '29', 'spread': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting plasma glucose', 'classes': [{'categories': [{'measurements': [{'value': '114', 'spread': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '0.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '% of total hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '2 hour plasma glucose concentration', 'classes': [{'categories': [{'measurements': [{'value': '177', 'spread': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'glucose concentration at 2h during screening OGTT', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'We studied male subjects with impaired fasting glucose or newly diagnosed type 2 diabetes.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-19', 'studyFirstSubmitDate': '2012-03-19', 'resultsFirstSubmitDate': '2015-10-28', 'studyFirstSubmitQcDate': '2012-04-26', 'lastUpdatePostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-17', 'studyFirstPostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism', 'timeFrame': '120 minutes after exenatide or placebo injection', 'description': 'To study the acute effect of exenatide on brain glucose metabolism after the glucose load. Brain glucose uptake will be determined from serial FDG PET-imaging, by using graphical methods to quantify both global and regional results. The results obtained after Exenatide injection will be compared with the ones obtained after injection of placebo in the same subject.'}], 'secondaryOutcomes': [{'measure': 'Effect of Exenatide on the Liver and Adipose Tissue Glucose Uptake', 'timeFrame': '60 minutes after exenatide or placebo injection', 'description': 'we evaluated the acute effects of exenatide on hepatic (Hep-IR) and adipose (Adipo-IR) insulin resistance and glucose uptake.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Impaired glucose tolerance (IGT)', 'Diabetes'], 'conditions': ['Impaired Glucose Tolerance (IGT)', 'Diabetes']}, 'referencesModule': {'references': [{'pmid': '26116695', 'type': 'RESULT', 'citation': 'Daniele G, Iozzo P, Molina-Carrion M, Lancaster J, Ciociaro D, Cersosimo E, Tripathy D, Triplitt C, Fox P, Musi N, DeFronzo R, Gastaldelli A. Exenatide Regulates Cerebral Glucose Metabolism in Brain Areas Associated With Glucose Homeostasis and Reward System. Diabetes. 2015 Oct;64(10):3406-12. doi: 10.2337/db14-1718. Epub 2015 Jun 26.'}, {'pmid': '27639082', 'type': 'RESULT', 'citation': 'Gastaldelli A, Gaggini M, Daniele G, Ciociaro D, Cersosimo E, Tripathy D, Triplitt C, Fox P, Musi N, DeFronzo R, Iozzo P. Exenatide improves both hepatic and adipose tissue insulin resistance: A dynamic positron emission tomography study. Hepatology. 2016 Dec;64(6):2028-2037. doi: 10.1002/hep.28827.'}]}, 'descriptionModule': {'briefSummary': 'This research study will examine brain glucose metabolism after an overnight fast to determine the effect of exenatide on brain glucose metabolism and lipid metabolism.', 'detailedDescription': 'This study will elucidate if exenatide has an effect on brain glucose metabolism. This will be accomplished by measuring the rate of glucose binding in various brain regions by Positron Emission Tomography (PET) after glucose load with exenatide injection and compare it with placebo injection measured in the same subject. The changes will be compared with peripheral and hepatic glucose metabolism and lipolysis.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males age 18-65 years old\n2. Patients must have Body Mass Index (BMI) between 25 and 40 kg/m2\n3. 2-hour glucose concentration above 140mg/dl after 75g glucose load, ie, having impaired glucose tolerance or newly diagnosed type 2 diabetes.\n4. Patients must have BMI of 25-40 kg/m2\n5. Patients must have no known severe liver or kidney disease, cancer, neurologic, psychiatric or systemic disease, ability to understand the study.\n6. Only patients whose body weight has been stable (±3-4 pounds) over the three months prior to study will be included.\n7. Patients must have the following laboratory values:\n\n * Hematocrit ≥ 34 vol%\n * Serum creatinine\\* ≤ 1.5 mg/dl in males and\n * Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT): ≤ 2.5 times upper limit of normal\n * Alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT): ≤ 2.5 times upper limit of normal\n * Alkaline phosphatase ≤ 2.5 times upper limit of normal\n * If serum creatinine is ≤ 1.5 mg/dl in males, the PI can grant an exception and not exclude the patient if the Glomerular filtration rate (GFR) is \\>70 ml/min\n\nExclusion Criteria:\n\nPatients are excluded from participation in the study if they meet any of the following criteria:\n\n1. Patients with major chronic illness (cancer, liver, kidney, cardiovascular disease)\n2. Patients with BMI over 40 and under 25\n3. Patient with age below 18 yrs and over 65 yrs\n4. Female subjects\n5. Patients with type 1 diabetes\n6. Patients treated for type 2 diabetes\n7. Subjects with normal glucose tolerance (NGT)'}, 'identificationModule': {'nctId': 'NCT01588418', 'briefTitle': 'Acute Effect of Exenatide on Brain Glucose Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'Effect of Exenatide on Brain Glucose Uptake in Relations to Pancreatic, Adipose Tissue, and Hepatic Function', 'orgStudyIdInfo': {'id': '233-GAS-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exenatide first, then Placebo', 'description': 'Exenatide 5mcg was injected subcutaneously 30 min before Oral Glucose Tolerance Test (OGTT)-PET study. The same subject was studied again a few weeks later with the same protocol with Placebo injection.', 'interventionNames': ['Drug: Exenatide', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo first, then Exenatide', 'description': 'Placebo was injected subcutaneously 30 min before OGTT-PET study. The same subject was studied again a few weeks later with the same protocol with injection of Exenatide 5mcg .', 'interventionNames': ['Drug: Exenatide', 'Drug: Placebo']}], 'interventions': [{'name': 'Exenatide', 'type': 'DRUG', 'otherNames': ['Byetta'], 'description': 'Exenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study', 'armGroupLabels': ['Exenatide first, then Placebo', 'Placebo first, then Exenatide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo was administered in random order 30 min before OGTT-PET study in the same subject', 'armGroupLabels': ['Exenatide first, then Placebo', 'Placebo first, then Exenatide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Diabetes Institute and UTHSCSA', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Amalia Gastaldelli, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTHSCSA, San Antonio, TX'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amylin Pharmaceuticals, LLC.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ralph DeFronzo', 'investigatorAffiliation': 'The University of Texas Health Science Center at San Antonio'}}}}