{"protocolSection":{"identificationModule":{"nctId":"NCT01484873","orgStudyIdInfo":{"id":"111185"},"organization":{"fullName":"Vanderbilt University Medical Center","class":"OTHER"},"briefTitle":"Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor","officialTitle":"Effects of Exenatide on Body Weight in Patients With Hypothalamic Obesity"},"statusModule":{"statusVerifiedDate":"2017-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2012-06"},"primaryCompletionDateStruct":{"date":"2015-03","type":"ACTUAL"},"completionDateStruct":{"date":"2015-03","type":"ACTUAL"},"studyFirstSubmitDate":"2011-10-20","studyFirstSubmitQcDate":"2011-12-01","studyFirstPostDateStruct":{"date":"2011-12-02","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-02-09","resultsFirstSubmitQcDate":"2016-06-29","resultsFirstPostDateStruct":{"date":"2016-08-11","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-01-17","lastUpdatePostDateStruct":{"date":"2017-03-03","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Ashley Shoemaker","investigatorTitle":"Assistant Professor of Pediatrics","investigatorAffiliation":"Vanderbilt University Medical Center"},"leadSponsor":{"name":"Vanderbilt University Medical Center","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of this study is to determine whether exenatide can cause weight loss in patients with a history of craniopharyngioma or other brain lesion.","detailedDescription":"Hypothalamic obesity occurs in up to 60% of patients with tumors in the hypothalamic region, most commonly craniopharyngiomas. Hypothalamic dysfunction can be due to tumor infiltration and as a consequence of surgery or radiation therapy. Survivors who develop obesity have greater morbidity and mortality than normal weight survivors. Prevention and treatment of obesity in this population is vital in order to decrease the morbidity and mortality from diabetes, stroke and myocardial infarction.\n\nExenatide (Byetta®) is a GLP-1 homologue that was FDA approved for treatment of type 2 diabetes in 2005. It also decreases the rate of gastric emptying and increases satiety and has been shown to cause weight loss in some people. Exenatide may improve insulin sensitivity and satiety in patients with hypothalamic obesity but without the risks of bariatric surgery. The investigators hypothesize that treatment with exenatide will lead to weight loss in patients with hypothalamic obesity."},"conditionsModule":{"conditions":["Obesity","Overweight","Craniopharyngioma"],"keywords":["Exenatide","Byetta","Hypothalamic Obesity","Obesity","Craniopharyngioma"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":10,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide","type":"EXPERIMENTAL","description":"All patients received exenatide 10mcg BID x 50 weeks","interventionNames":["Drug: Exenatide"]}],"interventions":[{"type":"DRUG","name":"Exenatide","description":"Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.","armGroupLabels":["Exenatide"],"otherNames":["Byetta"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Body Weight (kg)","description":"Change in body weight from baseline to end of study","timeFrame":"baseline, 50 weeks"}],"secondaryOutcomes":[{"measure":"Resting Energy Expenditure (Kcals Per Day)","description":"Change in resting energy expenditure from baseline to 50 weeks","timeFrame":"baseline, 50 weeks"},{"measure":"Visual Analogue Scales for Post-meal Satiety","description":"Change in visual analogue scales scores from baseline to 50 weeks. Higher score indicates greater satiety (minimum 0, maximum 100).","timeFrame":"baseline, 50 weeks"},{"measure":"Insulin Secretion (Area Under the Curve)","description":"Change in insulin secretion from baseline","timeFrame":"baseline, 50 weeks"},{"measure":"Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life)","description":"Change in the isotope excretion half life during a gastric emptying test at baseline and at 50 weeks","timeFrame":"baseline, 50 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Age 18 to 40 years old\n* History of craniopharyngioma or other lesion in the hypothalamic region\n* Greater than 6 months post-treatment, including chemotherapy, surgery or radiation\n* BMI \\>30 mg/m2\n* Females must be post-menopausal, surgically sterile or using effective birth control for at least 12 weeks\n\nExclusion Criteria:\n\n* HgbA1C \\>7%\n* Use of diabetes medications other than metformin in the past 12 weeks, including exenatide\n* Use of weight loss drugs or initiation of a weight loss program in past 3 months\n* Impaired renal function or history of kidney transplant\n* History of gall stones (unless s/p cholecystectomy), pancreatitis or alcoholism\n* Personal or family history of medullary carcinoma of the thyroid or MEN type 2\n* History of gastroparesis or other gastric motility problems as exenatide decreases gastric motility\n* History of allergic reaction to exenatide or other medication components\n* Other significant comorbidities other than pituitary deficiencies\n* Currently prescribed warfarin (exenatide may alter warfarin metabolism)\n* Pregnant or lactating females\n* History of severe hypoglycemia (BG \\<60 and requiring assistance from another person)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"40 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Ashley Shoemaker, M.D.","affiliation":"Vanderbilt University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Vanderbilt University","city":"Nashville","state":"Tennessee","zip":"37232","country":"United States","geoPoint":{"lat":36.16589,"lon":-86.78444}}]},"referencesModule":{"references":[{"pmid":"27133664","type":"RESULT","citation":"Lomenick JP, Buchowski MS, Shoemaker AH. A 52-week pilot study of the effects of exenatide on body weight in patients with hypothalamic obesity. Obesity (Silver Spring). 2016 Jun;24(6):1222-5. doi: 10.1002/oby.21493. Epub 2016 May 2."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"University clinics and online advertisements from June, 2012 - March, 2013","groups":[{"id":"FG000","title":"Exenatide","description":"exenatide 10 mcg twice daily"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"10"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"8"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Exenatide","description":"exenatide 10 mcg twice daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"10"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"2"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"8"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Gender","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"7"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"3"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"9"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"10"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"10"}]}]}]},{"title":"Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"137.2","spread":"37.6"}]}]}]},{"title":"Resting energy expenditure","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kcal/day","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2215.0","spread":"654.9"}]}]}]},{"title":"Satiety","description":"minimum 0, maximum 100","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mm","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"68.9","spread":"15.4"}]}]}]},{"title":"Insulin AUC","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"120 min*uU/mL","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"13076","spread":"7482"}]}]}]},{"title":"Gastric emptying half life","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"minutes","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"175.4","spread":"81.0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Body Weight (kg)","description":"Change in body weight from baseline to end of study","populationDescription":"Patients that completed the study","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"kg","timeFrame":"baseline, 50 weeks","groups":[{"id":"OG000","title":"Exenatide","description":"exenatide 10 mcg twice daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.4","lowerLimit":"-2.2","upperLimit":"4.9"}]}]}]},{"type":"SECONDARY","title":"Resting Energy Expenditure (Kcals Per Day)","description":"Change in resting energy expenditure from baseline to 50 weeks","populationDescription":"8 patients completed the study but one patient did not have REE data available due to technical difficulties","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"kcal/day","timeFrame":"baseline, 50 weeks","groups":[{"id":"OG000","title":"Exenatide","description":"exenatide 10 mcg twice daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-157.7","lowerLimit":"-766.1","upperLimit":"450.6"}]}]}]},{"type":"SECONDARY","title":"Visual Analogue Scales for Post-meal Satiety","description":"Change in visual analogue scales scores from baseline to 50 weeks. Higher score indicates greater satiety (minimum 0, maximum 100).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"mm","timeFrame":"baseline, 50 weeks","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.5","lowerLimit":"-19.7","upperLimit":"14.7"}]}]}]},{"type":"SECONDARY","title":"Insulin Secretion (Area Under the Curve)","description":"Change in insulin secretion from baseline","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"120 min*uU/mL x","timeFrame":"baseline, 50 weeks","groups":[{"id":"OG000","title":"Exenatide","description":"exenatide 10 mcg twice 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year","eventGroups":[{"id":"EG000","title":"Exenatide","description":"exenatide 10 mcg twice daily","seriousNumAffected":0,"seriousNumAtRisk":10,"otherNumAffected":10,"otherNumAtRisk":10}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":7,"numAtRisk":10}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":10}]},{"term":"Hypoglycemia","organSystem":"Endocrine disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":10}]},{"term":"Fatigue","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":10}]},{"term":"Mood swings","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":10}]},{"term":"Hives","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":10}]},{"term":"Headache","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":10}]},{"term":"Gastroenteritis","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":10}]},{"term":"Irregular heart beat","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":10}]},{"term":"Acute otitis media","organSystem":"Ear and labyrinth disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":10}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":10}]},{"term":"Myalgias","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":10}]},{"term":"Joint pain","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":10}]},{"term":"kidney stones","organSystem":"Renal and urinary disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":10}]},{"term":"URI","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":10}]},{"term":"Nose bleed","organSystem":"Blood and lymphatic system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":10}]},{"term":"Injection site reaction","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":10}]},{"term":"strep throat","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":10}]},{"term":"tingling/numbness","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":10}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Ashley Shoemaker","organization":"Vanderbilt University","email":"ashley.h.shoemaker@vanderbilt.edu","phone":"615-343-8116"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D009765","term":"Obesity"},{"id":"D050177","term":"Overweight"},{"id":"D003397","term":"Craniopharyngioma"},{"id":"D050035","term":"Sexual Infantilism"}],"ancestors":[{"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":"D017599","term":"Neuroectodermal Tumors"},{"id":"D009373","term":"Neoplasms, Germ Cell and Embryonal"},{"id":"D009370","term":"Neoplasms by Histologic Type"},{"id":"D009369","term":"Neoplasms"},{"id":"D009380","term":"Neoplasms, Nerve Tissue"},{"id":"D006059","term":"Gonadal Dysgenesis"},{"id":"D012734","term":"Disorders of Sex Development"},{"id":"D014564","term":"Urogenital Abnormalities"},{"id":"D052776","term":"Female Urogenital Diseases"},{"id":"D005261","term":"Female Urogenital Diseases and Pregnancy Complications"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D052801","term":"Male Urogenital Diseases"},{"id":"D000013","term":"Congenital Abnormalities"},{"id":"D009358","term":"Congenital, Hereditary, and Neonatal Diseases and Abnormalities"},{"id":"D006058","term":"Gonadal Disorders"},{"id":"D004700","term":"Endocrine System Diseases"},{"id":"D007006","term":"Hypogonadism"}]},"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}