{"protocolSection":{"identificationModule":{"nctId":"NCT00546728","orgStudyIdInfo":{"id":"SPHC 2007-02"},"organization":{"fullName":"St. Paul Heart Clinic","class":"OTHER"},"briefTitle":"The Vascular Effects of Exenatide Versus Metformin in Patients With Pre-Diabetes","officialTitle":"The Chronic and Acute Postprandial Vascular Effects of Exenatide vs. Metformin in Abdominally Obese Patients With Impaired Glucose Tolerance"},"statusModule":{"statusVerifiedDate":"2013-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-10"},"primaryCompletionDateStruct":{"date":"2011-07","type":"ACTUAL"},"completionDateStruct":{"date":"2011-07","type":"ACTUAL"},"studyFirstSubmitDate":"2007-10-17","studyFirstSubmitQcDate":"2007-10-17","studyFirstPostDateStruct":{"date":"2007-10-19","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-04-23","resultsFirstSubmitQcDate":"2013-09-05","resultsFirstPostDateStruct":{"date":"2013-11-08","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-09-05","lastUpdatePostDateStruct":{"date":"2013-11-08","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Aaron S. Kelly, Ph.D.","investigatorTitle":"Assistant Professor","investigatorAffiliation":"University of Minnesota"},"leadSponsor":{"name":"St. Paul Heart Clinic","class":"OTHER"},"collaborators":[{"name":"Amylin Pharmaceuticals, LLC.","class":"INDUSTRY"},{"name":"Eli Lilly and Company","class":"INDUSTRY"},{"name":"International Diabetes Center at Park Nicollet","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to compare the effects of exenatide versus metformin on vascular health with chronic (3-month) therapy and during a 2-hour period following a meal in patients with pre-diabetes. It is predicted that exenatide will improve vascular health to a greater degree compared to metformin."},"conditionsModule":{"conditions":["Impaired Glucose Tolerance"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":50,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide","type":"EXPERIMENTAL","description":"Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.","interventionNames":["Drug: Exenatide"]},{"label":"Metformin","type":"ACTIVE_COMPARATOR","description":"Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.","interventionNames":["Drug: Metformin"]}],"interventions":[{"type":"DRUG","name":"Exenatide","description":"exenatide 10 mcg twice daily","armGroupLabels":["Exenatide"]},{"type":"DRUG","name":"Metformin","description":"metformin 500 twice daily","armGroupLabels":["Metformin"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Reactive Hyperemic Index Over the 3-month Treatment Period","description":"Change in reactive hyperemic index over the 3-month treatment period, which is a measure of endothelial (inner lining of blood vessels) function. This is measured as a ratio of post-occlusion blood flow volume versus baseline blood flow volume in fingertips. Higher ratio values are considered indicative of better arterial health.","timeFrame":"Change from baseline to 3 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Greater than or equal to 18 years old\n* Impaired glucose tolerance: 2-hr oral glucose tolerance test (OGTT) plasma glucose \\>140 mg/dL OR impaired fasting glucose: fasting glucose \\> or = 100 mg/dL OR elevated glycosylated hemoglobin: Hemoglobin A1c \\> or = 5.7%\n* Abdominal obesity: waist circumference \\>102 cm (men) and \\>88 cm (women)\n* Stable cardiovascular medication regimen (or other medications known to affect endothelial function) at least 1 month prior to enrollment and throughout the study\n\nExclusion Criteria:\n\n* Type 2 diabetes\n* Current use of glycemic control medications within one month of randomization\n* Fasting glucose \\>126 mg/dL\n* Current use of weight loss medication\n* Previous weight loss surgery\n* History of severe gastrointestinal disease\n* Standard clinical contraindications to exenatide or metformin therapy\n* Unstable angina\n* Heart failure\n* Stroke or coronary artery bypass graft within 3 months of screening\n* Women who are currently pregnant or planning to become pregnant\n* Breastfeeding women\n* Clinically significant liver disease\n* Creatinine \\> 1.5 mg/dL\n* Hepatic function greater than 3 times upper limit of normal\n* Patients who are mentally incompetent and cannot sign a Patient Informed Consent","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Aaron S. Kelly, Ph.D.","affiliation":"University of Minnesota","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"International Diabetes Center at Park Nicollet","city":"Saint Louis Park","state":"Minnesota","zip":"55416","country":"United States","geoPoint":{"lat":44.9483,"lon":-93.34801}},{"facility":"St. Paul Heart Clinic","city":"Saint Paul","state":"Minnesota","zip":"55102","country":"United States","geoPoint":{"lat":44.94441,"lon":-93.09327}}]},"referencesModule":{"references":[{"pmid":"22681705","type":"DERIVED","citation":"Kelly AS, Bergenstal RM, Gonzalez-Campoy JM, Katz H, Bank AJ. Effects of exenatide vs. metformin on endothelial function in obese patients with pre-diabetes: a randomized trial. Cardiovasc Diabetol. 2012 Jun 8;11:64. doi: 10.1186/1475-2840-11-64."}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Patients were recruited from medical clinics","groups":[{"id":"FG000","title":"Exenatide","description":"Three months of Exenatide. Exenatide was initiated at a dose of 5 mcg, twice a day for one month and up titrated to 10 mcg, twice a day for the remaining two months."},{"id":"FG001","title":"Metformin","description":"Three months of Metformin. Metformin was initiated at a dose of 500 mg, twice a day for one month and up titrated to 1000 mg, twice a day for the remaining two months."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"25"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"25"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Exenatide","description":"Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months."},{"id":"BG001","title":"Metformin","description":"Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"50"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"50"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"58.7","spread":"10"},{"groupId":"BG001","value":"58.4","spread":"10.1"},{"groupId":"BG002","value":"58.5","spread":"10.0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"38"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"12"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"50"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Reactive Hyperemic Index Over the 3-month Treatment Period","description":"Change in reactive hyperemic index over the 3-month treatment period, which is a measure of endothelial (inner lining of blood vessels) function. This is measured as a ratio of post-occlusion blood flow volume versus baseline blood flow volume in fingertips. Higher ratio values are considered indicative of better arterial health.","populationDescription":"All completers were included in the analysis","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ratio","timeFrame":"Change from baseline to 3 months","groups":[{"id":"OG000","title":"Exenatide","description":"Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months."},{"id":"OG001","title":"Metformin","description":"Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"25"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.01","spread":"0.68"},{"groupId":"OG001","value":"-0.17","spread":"0.72"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"3-months","eventGroups":[{"id":"EG000","title":"Exenatide","description":"Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months.","seriousNumAffected":0,"seriousNumAtRisk":25,"otherNumAffected":0,"otherNumAtRisk":25},{"id":"EG001","title":"Metformin","description":"Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.","seriousNumAffected":0,"seriousNumAtRisk":25,"otherNumAffected":0,"otherNumAtRisk":25}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"unblinded study design"},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Aaron S. Kelly, Ph.D.","organization":"University of Minnesota","email":"kelly105@umn.edu","phone":"612-626-3492"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D018149","term":"Glucose Intolerance"}],"ancestors":[{"id":"D006943","term":"Hyperglycemia"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D000077270","term":"Exenatide"},{"id":"D008687","term":"Metformin"}],"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"},{"id":"D001645","term":"Biguanides"},{"id":"D006146","term":"Guanidines"},{"id":"D000578","term":"Amidines"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}