{"protocolSection":{"identificationModule":{"nctId":"NCT01237197","orgStudyIdInfo":{"id":"1009M88952"},"organization":{"fullName":"University of Minnesota","class":"OTHER"},"briefTitle":"Exenatide in Extreme Pediatric Obesity","officialTitle":"Exenatide in Extreme Pediatric Obesity"},"statusModule":{"statusVerifiedDate":"2014-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-10"},"primaryCompletionDateStruct":{"date":"2012-05","type":"ACTUAL"},"completionDateStruct":{"date":"2012-10","type":"ACTUAL"},"studyFirstSubmitDate":"2010-11-01","studyFirstSubmitQcDate":"2010-11-08","studyFirstPostDateStruct":{"date":"2010-11-09","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-09-10","resultsFirstSubmitQcDate":"2014-09-04","resultsFirstPostDateStruct":{"date":"2014-09-12","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-09-04","lastUpdatePostDateStruct":{"date":"2014-09-12","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of Minnesota","class":"OTHER"},"collaborators":[{"name":"Children's Hospitals and Clinics of Minnesota","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"Extreme pediatric obesity, the fastest growing category of obesity in youth, is associated with high risk for developing cardiovascular disease (CVD) and type 2 diabetes (T2DM). Obesity tracks strongly into adulthood and interventions early in life may reduce risk for developing cardiovascular disease and type 2 diabetes. Few drug therapies for weight loss have been evaluated in adolescents. Since exenatide is associated with weight loss and improves risk factors for cardiovascular disease and type 2 diabetes in adults, it may be useful in extremely obese youth. Our primary objective in this study is to generate preliminary data on the ability of exenatide to reduce body mass index (BMI) and improve risk factors for cardiovascular disease and type 2 diabetes in 26 extremely obese adolescents (age 12-19 years) in a three-month, randomized, double-blind, placebo-controlled pilot clinical trial. GLP-1 therapy has never been evaluated as a treatment for pediatric obesity and is an innovative approach to a challenging and significant health care problem.","detailedDescription":"26 (approximately 13 per site) extremely obese (Body mass index \\[BMI\\] \\> or = 1.2 times the 95th percentile or BMI \\> or = 35 kg/m2) adolescents (age 12-19 years old) will be enrolled in a six-month study consisting of a three-month, randomized, double-blind (participants and investigators), placebo-controlled pilot clinical trial phase followed by a three-month open-label extension during which all participants will receive exenatide. For the initial three-month phase, participants will be equally (by site) and randomly assigned to one of two groups: 1) exenatide plus lifestyle modification, or 2) placebo plus lifestyle modification. Following baseline testing, subjects will be randomly assigned to study group. Participants will return at one-month for titration and assessment of safety (blood draw and adverse event assessment) and injection/lifestyle modification compliance and at three-months for reassessment of baseline variables and injection/lifestyle modification compliance and allocation to study drug for the three-month open-label extension. Participants will return at four-months for assessment of safety (blood draw and adverse event assessment) and injection/lifestyle modification compliance and at six-months for reassessment of baseline variables and injection/lifestyle modification compliance.\n\nAll subjects, regardless of group assignment, will participate in the clinical lifestyle modification program offered through either the University of Minnesota or Children's Hospitals and Clinics weight management programs. Participants and their families receive regular (approximately bi-monthly) face-to-face and/or phone behavioral-, dietary-, and physical activity-counseling from a multi-disciplinary team of health care professionals including physicians, dieticians, registered nurses, psychologists, and exercise physiologists.\n\nScreening will include review of medical records for previous clinical and laboratory data. The following measures will be collected at baseline, 3 months, and 6 months. Subject will be asked to fast for a minimum of 12 hours."},"conditionsModule":{"conditions":["Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":26,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide, then Open-Label Exenatide","type":"EXPERIMENTAL","description":"Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)","interventionNames":["Drug: Exenatide"]},{"label":"Placebo, then Open Label Exenatide","type":"PLACEBO_COMPARATOR","description":"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.","interventionNames":["Drug: Exenatide","Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Exenatide","description":"Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study.","armGroupLabels":["Exenatide, then Open-Label Exenatide","Placebo, then Open Label Exenatide"],"otherNames":["Byetta"]},{"type":"DRUG","name":"Placebo","description":"Participants were randomized to a placebo injection for the first three months, then given open-label Exenatide for the remaining three months (Initiated at 5 mcg, twice per day, delivered by subcutaneous injection. After 1 month, exenatide was uptitrated to 10 mcg, twice per day for the remaining 2 months of the drug treatment phase).","armGroupLabels":["Placebo, then Open Label Exenatide"],"otherNames":["Sugar pill"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percent Change From Baseline in Body Mass Index at 3-months","description":"As results are measured by BMI reduction, percent change (reduction) in BMI is primary outcome measure.","timeFrame":"Baseline and 3-months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Body mass index \\> or = 1.2 times the 95th percentile (based on gender and age) or Body mass index \\> or = 35 kg/m2\n* 12-19 years old\n\nExclusion Criteria:\n\n* Type 1 or 2 diabetes mellitus\n* Previous (within 3-months) or current use of weight loss medication (patients may undergo washout)\n* Previous bariatric surgery\n* Recent initiation (within 1-month) of anti-hypertensive or lipid medication\n* Previous (within 1-month) or current use of medication to treat insulin resistance or hyperglycemia (patients may undergo washout)\n* Major psychiatric disorder\n* Pregnant or planning to become pregnant\n* Tobacco use\n* Liver/renal dysfunction\n* History of pancreatitis\n* Obesity associated with genetic disorder\n* Hyperthyroidism or uncontrolled hypothyroidism\n* Uncontrolled hypertriglyceridemia (=300 mg/dL)\n* Current eating disorder\n* Previous (within 3-months) or current use of drugs associated with weight gain (e.g. steroids/anti-psychotics)","healthyVolunteers":false,"sex":"ALL","minimumAge":"12 Years","maximumAge":"19 Years","stdAges":["CHILD","ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Aaron S. Kelly, Ph.D.","affiliation":"University of Minnesota","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","zip":"55455","country":"United States","geoPoint":{"lat":44.97997,"lon":-93.26384}},{"facility":"Children's Hospitals and Clinics of Minnesota","city":"Saint Paul","state":"Minnesota","zip":"55102","country":"United States","geoPoint":{"lat":44.94441,"lon":-93.09327}}]},"referencesModule":{"references":[{"pmid":"23380890","type":"DERIVED","citation":"Kelly AS, Rudser KD, Nathan BM, Fox CK, Metzig AM, Coombes BJ, Fitch AK, Bomberg EM, Abuzzahab MJ. The effect of glucagon-like peptide-1 receptor agonist therapy on body mass index in adolescents with severe obesity: a randomized, placebo-controlled, clinical trial. JAMA Pediatr. 2013 Apr;167(4):355-60. doi: 10.1001/jamapediatrics.2013.1045."}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Participants were recruited from the University of Minnesota, Amplatz Children's Hospital Pediatric Weight Management Clinic in Minneapolis or the McNeely Pediatric Diabetes Center and Endocrinology Clinic, Children's Hospitals and Clinics of Minnesota in St Paul.","groups":[{"id":"FG000","title":"Exenatide","description":"Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)\n\nOpen label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."},{"id":"FG001","title":"Placebo Injection","description":"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.\n\nOpen label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."}],"periods":[{"title":"Randomization Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"13"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}]}]},{"title":"Open Label Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Exenatide","description":"Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)\n\nOpen label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."},{"id":"BG001","title":"Placebo Injection","description":"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.\n\nOpen label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"26"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"26"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"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":"14.9","spread":"1.76"},{"groupId":"BG001","value":"15.5","spread":"1.88"},{"groupId":"BG002","value":"15.2","spread":"1.8"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"16"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"10"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"26"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Percent Change From Baseline in Body Mass Index at 3-months","description":"As results are measured by BMI reduction, percent change (reduction) in BMI is primary outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage of change in BMI","timeFrame":"Baseline and 3-months","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide 5 micrograms (mcg): administered with injection twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)\n\nOpen Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."},{"id":"OG001","title":"Placebo Injection","description":"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.\n\nOpen Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.9","spread":"1.8","lowerLimit":"-5.02","upperLimit":"-0.37"},{"groupId":"OG001","value":"-0.15","spread":"3.2"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Exenatide","description":"Exenatide 5 micrograms (mcg): administered with injection twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)\n\nOpen Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study.","seriousNumAffected":0,"seriousNumAtRisk":13,"otherNumAffected":12,"otherNumAtRisk":13},{"id":"EG001","title":"Placebo Injection","description":"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.\n\nOpen Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study.","seriousNumAffected":0,"seriousNumAtRisk":13,"otherNumAffected":12,"otherNumAtRisk":13}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":13,"numAffected":8,"numAtRisk":13},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":13}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":4,"numAtRisk":13},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":13}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":13},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":13}]},{"term":"Headache","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":13},{"groupId":"EG001","numEvents":6,"numAffected":6,"numAtRisk":13}]}]},"moreInfoModule":{"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":"D009765","term":"Obesity"}],"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"}]},"interventionBrowseModule":{"meshes":[{"id":"D000077270","term":"Exenatide"},{"id":"D000073893","term":"Sugars"}],"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":"D002241","term":"Carbohydrates"}]}},"hasResults":true}