{"protocolSection":{"identificationModule":{"nctId":"NCT00456885","orgStudyIdInfo":{"id":"2006P000361"},"secondaryIdInfos":[{"id":"BFA912"}],"organization":{"fullName":"Beth Israel Deaconess Medical Center","class":"OTHER"},"briefTitle":"The Effect of Exenatide on Weight and Hunger in Obese, Healthy Women","officialTitle":"The Effect of Exenatide on Body Weight, Energy Expenditure and Hunger in Obese Women Without Diabetes Mellitus"},"statusModule":{"statusVerifiedDate":"2017-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-04"},"primaryCompletionDateStruct":{"date":"2010-09","type":"ACTUAL"},"completionDateStruct":{"date":"2010-09","type":"ACTUAL"},"studyFirstSubmitDate":"2007-04-04","studyFirstSubmitQcDate":"2007-04-04","studyFirstPostDateStruct":{"date":"2007-04-05","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-03-30","resultsFirstSubmitQcDate":"2017-08-09","resultsFirstPostDateStruct":{"date":"2017-09-11","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-08-09","lastUpdatePostDateStruct":{"date":"2017-09-11","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Eleftheria Maratos-Flier","investigatorTitle":"Professor of Medicine","investigatorAffiliation":"Beth Israel Deaconess Medical Center"},"leadSponsor":{"name":"Beth Israel Deaconess Medical Center","class":"OTHER"},"collaborators":[{"name":"Amylin Pharmaceuticals, LLC.","class":"INDUSTRY"},{"name":"Eli Lilly and Company","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This study will look at the effect of exenatide, a drug which has been approved for the treatment of type 2 diabetes, on body weight, appetite and energy expenditure among moderately obese women without diabetes.\n\nThe study is 35 weeks long and includes 19 outpatient visits. Participants will receive exenatide for 16 weeks and placebo for 16 weeks with a 3 week rest period in between. Neither participants nor investigators will know whether exenatide or placebo is being administered. Participants will be started randomly on either exenatide or placebo.\n\nOur hypothesis is that treatment with exenatide will curb appetite and lead to weight loss and may lead to changes in energy expenditure.","detailedDescription":"This study will examine the effect of exenatide on body weight, energy expenditure, satiety, sleep, and metabolic parameters in healthy, moderately obese women (BMI 28-35 kg/m2). We will look at 2 populations of women, one with normal glucose metabolism and one with impaired glucose homeostasis (IGH)--either impaired fasting glucose (IFG, fasting glucose 101-125 mg/dL) or impaired glucose tolerance (IGT, glucose 140-199 mg/dL 2h after a 75g oral glucose load). This is a randomized, double blind, crossover study with two 16-week treatment periods separated by a 3-week washout period. There are 19 study visits over 35 weeks.\n\nThe goals of this study are 1) to examine the effect of exenatide on body weight and dysglycemia in populations in which this medication has not been studied, namely obese women with and without IGH and 2) to investigate possible mechanisms of weight loss through measurements of energy expenditure, hunger, satiety, nausea, and sleep.\n\nThe primary outcome of this study is weight loss. We will calculate absolute and relative change in body weight from baseline to week 16 (the first treatment period) and from week 19 to week 35 (the second treatment period). Body weight will be measured at every study visit which will also allow us to assess the absolute and relative change from baseline throughout the entire study."},"conditionsModule":{"conditions":["Obesity","Impaired Glucose Tolerance"],"keywords":["obesity","double blind","placebo controlled","weight loss","appetite","energy expenditure"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":41,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide First","type":"PLACEBO_COMPARATOR","description":"Started on Exenatide, 3 week washout, start placebo","interventionNames":["Drug: exenatide","Drug: Placebo"]},{"label":"Placebo First","type":"EXPERIMENTAL","description":"Started on placebo, 3 week washout, start exenatide","interventionNames":["Drug: exenatide","Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"exenatide","description":"5 microgram twice a day for two week and then 10 mcg for remaining 15 weeks","armGroupLabels":["Exenatide First","Placebo First"],"otherNames":["Byetta"]},{"type":"DRUG","name":"Placebo","description":"Twice daily injection of placebo","armGroupLabels":["Exenatide First","Placebo First"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Weight","description":"Change in weight at the end of each treatment period.","timeFrame":"16 weeks after the beginning of each treatment"},{"measure":"Change in Body Mass Index","timeFrame":"16 weeks from the start of each treatment period."}],"secondaryOutcomes":[{"measure":"Change in Waist Circumference","timeFrame":"16 weeks from the start of each treatment period."},{"measure":"Systolic Blood Pressure","description":"Blood pressure was measured using a Dynamap automated monitoring device. The change is reported as the blood pressure measured at the beginning of the treatment group and after 16 weeks. We are reporting the change in the systolic blood presssure recorded.","timeFrame":"16 weeks after the beginning of each treatment"},{"measure":"Changes in Body Composition","description":"Per cent body body fat was assessed using bio-electrical impedance with a BIA; RJL System Quantum II Bioelectrical Body Composition Analyzer. The data is reported as per cent body fat.","timeFrame":"16 weeks after the beginning of each treatment"},{"measure":"Changes in Leptin","timeFrame":"16 weeks from the start of each treatment period."},{"measure":"Diastolic Blood Pressure","timeFrame":"16 weeks after the beginning of each treatment"},{"measure":"Adiponectin","timeFrame":"16 weeks after the beginning of each treatment"},{"measure":"Change in Insulin","timeFrame":"16 weeks from the start of each treatment period."},{"measure":"Change in Fasting Glucose","timeFrame":"16 weeks from the start of each treatment period."},{"measure":"Change in Two Hour Glucose","timeFrame":"16 weeks from the start of each treatment period."},{"measure":"HOMA Score","timeFrame":"16 weeks from the start of each treatment period."},{"measure":"REE","description":"Resting Energy Expenditure","timeFrame":"16 weeks from the start of each treatment period."}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Females aged 25-60\n2. BMI 28-35 kg/m2\n3. No known diagnosis of diabetes\n4. No known diagnosis of coronary heart disease\n5. Self-described sedentary lifestyle with minimal regular cardiovascular exercise (no more than 1 hour per week)\n6. Stable weight (variation \\< 3 kg within 6 months of screening visit)\n7. Ability to give informed consent\n8. Ability to follow verbal and written instructions\n9. Use of medically approved form of contraception (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods)\n10. Nonsmoker (tobacco, marijuana)\n11. Outpatient visits every 2 weeks throughout the study period are required. While most of these visits are short (15 minutes)ability to commute to the performance site in Boston, on a regular basis, is necessary.\n\nExclusion Criteria:\n\n1. Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria\n2. Coronary heart disease (history of myocardial infarction or unstable angina pectoris)\n3. Uncontrolled hypertension hypertension (BP \\> 150/90 mmHg on or off antihypertensive medication)\n4. Uncontrolled dyslipidemia (LDL \\> 200 or TG \\> 400 on or off lipid lowering medication)\n5. Tobacco, marijuana or intravenous drug use\n6. Shift workers (night shift or alternating day/night shifts)\n7. Recent weight loss (\\> 3 kg within 4 months of the screening visit)\n8. Gastroparesis\n9. Inflammatory bowel disease\n10. Malignancy treated with chemotherapy within the past 3 years\n11. History of pancreatitis\n12. Depression requiring hospitalization or diagnosis of psychosis\n13. Renal insufficiency (creatinine clearance \\< 50 ml/min)\n14. Transaminases \\> 2x above the normal range\n15. Pregnancy within 6 months of the screening visit\n16. Breastfeeding\n17. Failure to use medically approved contraceptive methods\n18. History of an eating disorder (anorexia, bulimia or laxative abuse)\n19. History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)\n20. New diagnosis of hypo or hyperthyroidism within 1 year of screening visit\n21. Previous participation in a clinical study with exenatide\n22. Presence or history of allergic reaction to multiple drugs","healthyVolunteers":true,"sex":"FEMALE","minimumAge":"25 Years","maximumAge":"60 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Eleftheria Maratos-Flier, MD","affiliation":"Beth Israel Deaconess Medical Center","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Beth Israel Deaconess Medical Center","city":"Boston","state":"Massachusetts","zip":"02215","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}}]},"referencesModule":{"references":[{"pmid":"22040840","type":"RESULT","citation":"Dushay J, Gao C, Gopalakrishnan GS, Crawley M, Mitten EK, Wilker E, Mullington J, Maratos-Flier E. Short-term exenatide treatment leads to significant weight loss in a subset of obese women without diabetes. Diabetes Care. 2012 Jan;35(1):4-11. doi: 10.2337/dc11-0931. Epub 2011 Oct 31."}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Flyers, Craig's list, posters used for recruitment.Recruitment occurred between 2007 and 2010. After telephone screen subjects were evaluated at the BIDMC clinical research center.","groups":[{"id":"FG000","title":"Exenatide First, Then Placebo","description":"Started on exenatide, 3 week washout, started on placebo."},{"id":"FG001","title":"Placebo First, Then Exenatide","description":"Started on placebo, three week washout, started on exenatide."}],"periods":[{"title":"First Treatment Period, 16 Weeks","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"17"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"17"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Washout, 3 Weeks","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"17"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"17"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Second Treatment Period, 16 Weeks","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"17"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"17"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"All Study Participants","description":"All participants in the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"41"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"48","spread":"11"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"41"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"41"}]}]}]},{"title":"Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Kilograms","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"89","spread":"14"}]}]}]},{"title":"BMI","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Kg/meter^2","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"33","spread":"4"}]}]}]},{"title":"HOMA IR","description":"This is the ratio of fasting glucose to fasting insulin. It has no definable upper limit. We are showing scores in our study participants.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Ratio","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2","spread":"1"}]}]}]},{"title":"Waist","description":"centimeters","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"centrimeters","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"105","spread":"12"}]}]}]},{"title":"Body Fat","description":"Measured using bio-electrical impedance","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percent","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"40","spread":"5"}]}]}]},{"title":"Systolic BP","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mm of mercury","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"128","spread":"14"}]}]}]},{"title":"Diastolic BP","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mm of Mercury","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"75","spread":"8"}]}]}]},{"title":"HDL","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mg/dl","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"62","spread":"19"}]}]}]},{"title":"LDL","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mg/dl","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"114","spread":"28"}]}]}]},{"title":"Total Cholesterol","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mg/dl","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"198","spread":"32"}]}]}]},{"title":"Triglycerides","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mg/dl","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"111","spread":"64"}]}]}]},{"title":"Fasting Insulin","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mU per liter","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8","spread":"6"}]}]}]},{"title":"Fasting Glucose","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mg/dl","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"85","spread":"12"}]}]}]},{"title":"Two Hour Glucose","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mg/dl","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"110","spread":"32"}]}]}]},{"title":"Adiponectin","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"micrograms/ml","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6","spread":"3"}]}]}]},{"title":"Leptin","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"ng/ml","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"36","spread":"18"}]}]}]},{"title":"Resting Energy Expenditure","description":"Using indirect calorimetry","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Kilocalories","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1439","spread":"196"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Weight","description":"Change in weight at the end of each treatment period.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilograms","timeFrame":"16 weeks after the beginning of each treatment","groups":[{"id":"OG000","title":"Exenatide","description":"All participants that received exenatide."},{"id":"OG001","title":"Placebo","description":"All participants that received placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.49","spread":"0.66"},{"groupId":"OG001","value":"0.43","spread":"0.63"}]}]}]},{"type":"PRIMARY","title":"Change in Body Mass Index","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Kg/m^2","timeFrame":"16 weeks from the start of each treatment period.","groups":[{"id":"OG000","title":"Exenatide","description":"All participants that received exenatide."},{"id":"OG001","title":"Placebo","description":"All participants that received placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.93","lowerLimit":"-1.44","upperLimit":"-0.41"},{"groupId":"OG001","value":"0.18","lowerLimit":"-0.31","upperLimit":"0.68"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"centimeters","timeFrame":"16 weeks from the start of each treatment period.","groups":[{"id":"OG000","title":"Exenatide","description":"All participants that received exenatide."},{"id":"OG001","title":"Placebo","description":"All participants that received placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.68","lowerLimit":"-3.3","upperLimit":"-0.07"},{"groupId":"OG001","value":"0.94","lowerLimit":"-0.59","upperLimit":"2.47"}]}]}]},{"type":"SECONDARY","title":"Systolic Blood Pressure","description":"Blood pressure was measured using a Dynamap automated monitoring device. The change is reported as the blood pressure measured at the beginning of the treatment group and after 16 weeks. We are reporting the change in the systolic blood presssure recorded.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"mm of mercury","timeFrame":"16 weeks after the beginning of each treatment","groups":[{"id":"OG000","title":"Exenatide","description":"All participants that received exenatide."},{"id":"OG001","title":"Placebo","description":"All participants that received placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.5","lowerLimit":"-6.6","upperLimit":"1.6"},{"groupId":"OG001","value":"-1.3","lowerLimit":"-5.2","upperLimit":"2.6"}]}]}]},{"type":"SECONDARY","title":"Changes in Body Composition","description":"Per cent body body fat was assessed using bio-electrical impedance with a BIA; RJL System Quantum II Bioelectrical Body Composition Analyzer. The data is reported as per cent body fat.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"per cent","timeFrame":"16 weeks after the beginning of each treatment","groups":[{"id":"OG000","title":"Exenatide","description":"All participants that received exenatide."},{"id":"OG001","title":"Placebo","description":"All participants that received placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","lowerLimit":"-1.5","upperLimit":"0.7"},{"groupId":"OG001","value":"-0.7","lowerLimit":"-1.8","upperLimit":"0.3"}]}]}]},{"type":"SECONDARY","title":"Changes in Leptin","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"ng/ml","timeFrame":"16 weeks from the start of each treatment period.","groups":[{"id":"OG000","title":"Exenatide","description":"All participants that received exenatide."},{"id":"OG001","title":"Placebo","description":"All participants that received placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.7","lowerLimit":"-7.4","upperLimit":"0.05"},{"groupId":"OG001","value":"-0.2","lowerLimit":"-3.8","upperLimit":"3.3"}]}]}]},{"type":"SECONDARY","title":"Diastolic Blood Pressure","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"mm of mercury","timeFrame":"16 weeks after the beginning of each treatment","groups":[{"id":"OG000","title":"Exenatide","description":"All participants that received exenatide."},{"id":"OG001","title":"Placebo","description":"All participants that received placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","lowerLimit":"-3.6","upperLimit":"1.1"},{"groupId":"OG001","value":"-0.4","lowerLimit":"-2.6","upperLimit":"1.9"}]}]}]},{"type":"SECONDARY","title":"Adiponectin","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"microgram per ml","timeFrame":"16 weeks after the beginning of each treatment","groups":[{"id":"OG000","title":"Exenatide","description":"All participants that received exenatide."},{"id":"OG001","title":"Placebo","description":"All participants that received placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.4","lowerLimit":"-0.3","upperLimit":"1.0"},{"groupId":"OG001","value":"0.07","lowerLimit":"-0.5","upperLimit":"0.7"}]}]}]},{"type":"SECONDARY","title":"Change in Insulin","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"microunits per liter","timeFrame":"16 weeks from the start of each treatment period.","groups":[{"id":"OG000","title":"Exenatide","description":"All participants that received exenatide."},{"id":"OG001","title":"Placebo","description":"All participants that received 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placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-13.7","lowerLimit":"-60.6","upperLimit":"33.2"},{"groupId":"OG001","value":"6.5","lowerLimit":"-38.0","upperLimit":"51.0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"37 weeks","description":"Adverse effects were monitored as all participant adverse events and were not monitored by intervention or sequence.","eventGroups":[{"id":"EG000","title":"All Study Participants","deathsNumAffected":0,"deathsNumAtRisk":41,"seriousNumAffected":0,"seriousNumAtRisk":41,"otherNumAffected":31,"otherNumAtRisk":41}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Nausea","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":41}]},{"term":"Bloating","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Bloating","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":41}]},{"term":"Irritation at injection site","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":41}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":41}]},{"term":"Fatigue","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":41}]},{"term":"Heartburn","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":41}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":41}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Jody Dushay","organization":"BIDMC","email":"jdushay@bidmc.harvard.edu","phone":"6177353343","phoneExt":"617"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D009765","term":"Obesity"},{"id":"D018149","term":"Glucose Intolerance"},{"id":"D015431","term":"Weight Loss"}],"ancestors":[{"id":"D050177","term":"Overweight"},{"id":"D044343","term":"Overnutrition"},{"id":"D009748","term":"Nutrition Disorders"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D001835","term":"Body Weight"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"},{"id":"D006943","term":"Hyperglycemia"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D001836","term":"Body Weight Changes"}]},"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"}]}},"hasResults":true}