{"protocolSection":{"identificationModule":{"nctId":"NCT03115424","orgStudyIdInfo":{"id":"16-004253"},"organization":{"fullName":"Mayo Clinic","class":"OTHER"},"briefTitle":"Effect of GLP-1 Receptor Agonism After Sleeve Gastrectomy","officialTitle":"Effect of GLP-1 Receptor Agonism on Weight and Caloric Intake in Subjects After Sleeve Gastrectomy"},"statusModule":{"statusVerifiedDate":"2024-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2017-06-22","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-10-04","type":"ACTUAL"},"completionDateStruct":{"date":"2024-05-30","type":"ACTUAL"},"studyFirstSubmitDate":"2017-04-05","studyFirstSubmitQcDate":"2017-04-11","studyFirstPostDateStruct":{"date":"2017-04-14","type":"ACTUAL"},"resultsFirstSubmitDate":"2024-08-29","resultsFirstSubmitQcDate":"2024-09-24","resultsFirstPostDateStruct":{"date":"2024-09-27","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-09-24","lastUpdatePostDateStruct":{"date":"2024-09-27","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Adrian Vella","investigatorTitle":"Professor of Medicine","investigatorAffiliation":"Mayo Clinic"},"leadSponsor":{"name":"Mayo Clinic","class":"OTHER"},"collaborators":[{"name":"Novo Nordisk A/S","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"Observational studies suggest that bariatric surgery is the most effective intervention for weight loss. Comparative effectiveness of Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG) demonstrate that RYGB is significantly superior to SG in terms of weight loss and glycemic control. Both RYGB and SG increase GLP-1 concentrations which directly affect B-cell function. Data has shown that the postprandial rise in GLP-1 might affect feeding behavior after RYGB and to a lesser extent SG, where the increase in GLP-1 is less marked. In this study the investigators propose to randomize subjects undergoing SG to receive either placebo or Liraglutide, a GLP-1 receptor agonist, to compare weight loss and CV risk factors.","detailedDescription":"A total of 75, non diabetic adults, scheduled for bariatric surgery at Mayo Clinic Rochester, will be enrolled. Of these, 25 will be scheduled for Roux-en-Y Gastric Bypass surgery (RYGB), while the remainder (50) will be scheduled for Sleeve Gastrectomy (SG). The study team will play no role in assignment of the surgical procedure. Following surgery, at month 3, subjects undergoing SG will be randomized to either Saxenda or placebo, subcutaneously once daily. Subjects randomized to Saxenda or placebo will take for the duration of the study (33 months). Follow up study visits for all subjects will be timed to coincide with the standard clinical follow up visits at months 3, 6, 9, 12, 18, 24, 30 and 36."},"conditionsModule":{"conditions":["Obesity"],"keywords":["Weight Loss","Bariatric Surgery"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"OTHER","maskingInfo":{"masking":"TRIPLE","maskingDescription":"Double-blind design.","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR"]}},"enrollmentInfo":{"count":46,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Sleeve Gastrectomy Placebo","type":"PLACEBO_COMPARATOR","description":"Subjects undergoing Sleeve Gastrectomy (SG) will be randomized 1:1 at the time of 3 month visit after bariatric surgery.","interventionNames":["Drug: Placebos"]},{"label":"Sleeve Gastrectomy Saxenda","type":"ACTIVE_COMPARATOR","description":"Subjects undergoing Sleeve Gastrectomy (SG) will be randomized 1:1 at the time of 3 month visit after bariatric surgery.","interventionNames":["Drug: Saxenda"]},{"label":"RYGB","type":"SHAM_COMPARATOR","description":"Twenty five subjects will be recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.","interventionNames":["Procedure: RYGB"]}],"interventions":[{"type":"DRUG","name":"Saxenda","description":"Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects will be recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will be randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study (33 months). After undergoing surgery, study visits will be timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.","armGroupLabels":["Sleeve Gastrectomy Saxenda"],"otherNames":["Liraglutide"]},{"type":"DRUG","name":"Placebos","description":"Subjects will be recruited and screened prior to undergoing bariatric surgery.Subjects undergoing SG will be randomized 1:1 at months 3 post surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study (33 months). After undergoing surgery, study visits will be timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.","armGroupLabels":["Sleeve Gastrectomy Placebo"],"otherNames":["Placebo for Saxenda (Liraglutide)"]},{"type":"PROCEDURE","name":"RYGB","description":"Subjects will be recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits will be timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.","armGroupLabels":["RYGB"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Weight","description":"Subjects calculated weight in kilograms","timeFrame":"baseline and 36 months"}],"secondaryOutcomes":[{"measure":"Systolic Blood Pressure","description":"Systolic blood pressure (top number of blood pressure reading)","timeFrame":"baseline and 36 months"},{"measure":"Diastolic Blood Pressure","description":"Diastolic blood pressure (bottom number of blood pressure reading)","timeFrame":"baseline and 36 months"},{"measure":"Low-density Lipoprotein (LDL)","description":"LDL's carry cholesterol through the bloodstream. LDL is called bad cholesterol because high amounts can form plaques in the blood vessels, increasing risk for heart disease. Adult normal range is less than 100 mg/dL.","timeFrame":"baseline and 36 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Age 20-65 years of age\n2. Seen at Mayo Clinic Nutrition Clinic and have received authorization for bariatric surgery.\n3. No active physical illness which will interfere with mobility or weight loss after bariatric surgery.\n4. Females who are sexually active and able to become pregnant must agree to use birth control for duration of study if randomized to Saxenda/Placebo.\n\nExclusion Criteria:\n\n1. Prior use of glucose lowering medication in the 3 months prior to screening.\n2. A fasting glucose ≥ 126mg/dl or an HbA1c ≥ 6.5% will be taken as evidence of type 2 diabetes and therefore patients will be deemed ineligible for participation.\n3. Prior abdominal surgery other than cholecystectomy, appendectomy or hysterectomy.\n4. Pregnancy or active consideration of pregnancy during the period of study. Subjects will be discontinued if they become pregnant during the study.\n5. Hypersensitivity to liraglutide or any product components.\n6. Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2.\n7. Prior history of pancreatitis, cholelithiasis or cholecystitis.\n8. Concurrent use of insulin or any other GLP-1 receptor agonist.\n9. Active, severe psychiatric disease","healthyVolunteers":true,"sex":"ALL","minimumAge":"20 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Adrian Vella","affiliation":"Mayo Clinic","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Mayo Clinic in Rochester","city":"Rochester","state":"Minnesota","zip":"55905","country":"United States","geoPoint":{"lat":44.02163,"lon":-92.4699}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Sleeve Gastrectomy Saxenda","description":"Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.\n\nSaxenda: Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will were randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36."},{"id":"FG001","title":"Sleeve Gastrectomy Placebo","description":"Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.\n\nPlacebos: Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG were randomized 1:1 at months 3 post-surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects remained on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36."},{"id":"FG002","title":"Roux-en-Y Gastric (RYGB)","description":"Subjects were recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.\n\nRYGB: Subjects were recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"25"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"25"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Sleeve Gastrectomy Saxenda","description":"Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.\n\nSaxenda: Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will were randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36."},{"id":"BG001","title":"Sleeve Gastrectomy Placebo","description":"Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.\n\nPlacebos: Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG were randomized 1:1 at months 3 post-surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects remained on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36."},{"id":"BG002","title":"Roux-en-Y Gastric (RYGB)","description":"Subjects were recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.\n\nRYGB: Subjects were recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"46"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"46"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"46","spread":"12"},{"groupId":"BG001","value":"46","spread":"11"},{"groupId":"BG002","value":"42","spread":"9"},{"groupId":"BG003","value":"43","spread":"10"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"46"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"22"},{"groupId":"BG003","value":"40"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"6"}]}]}]},{"title":"Race and Ethnicity Not Collected","populationDescription":"Race and Ethnicity were not collected from any participant.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}],"categories":[{"measurements":[{"groupId":"BG003","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"46"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"46"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Weight","description":"Subjects calculated weight in kilograms","populationDescription":"Data was not collected nor analyzed for eight subjects in the Sleeve Gastrectomy Saxenda arm. Data was not collected nor analyzed for seven subjects in the Sleeve Gastrectomy Placebo arm. Data was not collected nor analyzed for thirteen subjects in the Roux-en-Y Gastric (RYGB).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilograms","timeFrame":"baseline and 36 months","groups":[{"id":"OG000","title":"Sleeve Gastrectomy Saxenda","description":"Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.\n\nSaxenda: Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will were randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36."},{"id":"OG001","title":"Sleeve Gastrectomy Placebo","description":"Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.\n\nPlacebos: Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG were randomized 1:1 at months 3 post-surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects remained on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36."},{"id":"OG002","title":"Roux-en-Y Gastric (RYGB)","description":"Subjects were recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.\n\nRYGB: Subjects were recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"25"}]}],"classes":[{"title":"baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"25"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"127","spread":"7"},{"groupId":"OG001","value":"130","spread":"8"},{"groupId":"OG002","value":"126","spread":"4"}]}]},{"title":"36 months","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"12"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"75","spread":"8"},{"groupId":"OG001","value":"107","spread":"10"},{"groupId":"OG002","value":"98","spread":"7"}]}]}]},{"type":"SECONDARY","title":"Systolic Blood Pressure","description":"Systolic blood pressure (top number of blood pressure reading)","populationDescription":"Data was not collected nor analyzed for eight subjects in the Sleeve Gastrectomy Saxenda arm. Data was not collected nor analyzed for seven subjects in the Sleeve Gastrectomy Placebo arm. Data was not collected nor analyzed for thirteen subjects in the Roux-en-Y Gastric (RYGB).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Millimeters of Mercury","timeFrame":"baseline and 36 months","groups":[{"id":"OG000","title":"Sleeve Gastrectomy Saxenda","description":"Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.\n\nSaxenda: Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will were randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36."},{"id":"OG001","title":"Sleeve Gastrectomy Placebo","description":"Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.\n\nPlacebos: Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG were randomized 1:1 at months 3 post-surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects remained on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36."},{"id":"OG002","title":"Roux-en-Y Gastric (RYGB)","description":"Subjects were recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.\n\nRYGB: Subjects were recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"25"}]}],"classes":[{"title":"baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"25"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"129","spread":"4"},{"groupId":"OG001","value":"130","spread":"7"},{"groupId":"OG002","value":"123","spread":"4"}]}]},{"title":"36 months","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"12"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"112","spread":"7"},{"groupId":"OG001","value":"128","spread":"1"},{"groupId":"OG002","value":"122","spread":"7"}]}]}]},{"type":"SECONDARY","title":"Diastolic Blood Pressure","description":"Diastolic blood pressure (bottom number of blood pressure reading)","populationDescription":"Data was not collected nor analyzed for eight subjects in the Sleeve Gastrectomy Saxenda arm. Data was not collected nor analyzed for seven subjects in the Sleeve Gastrectomy Placebo arm. Data was not collected nor analyzed for thirteen subjects in the Roux-en-Y Gastric (RYGB).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Millimeters of Mercury","timeFrame":"baseline and 36 months","groups":[{"id":"OG000","title":"Sleeve Gastrectomy Saxenda","description":"Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.\n\nSaxenda: Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will were randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36."},{"id":"OG001","title":"Sleeve Gastrectomy Placebo","description":"Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.\n\nPlacebos: Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG were randomized 1:1 at months 3 post-surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects remained on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36."},{"id":"OG002","title":"Roux-en-Y Gastric (RYGB)","description":"Subjects were recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.\n\nRYGB: Subjects were recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"25"}]}],"classes":[{"title":"baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"25"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"86","spread":"3"},{"groupId":"OG001","value":"83","spread":"6"},{"groupId":"OG002","value":"76","spread":"2"}]}]},{"title":"36 months","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"12"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"84","spread":"4"},{"groupId":"OG001","value":"93","spread":"13"},{"groupId":"OG002","value":"82","spread":"3"}]}]}]},{"type":"SECONDARY","title":"Low-density Lipoprotein (LDL)","description":"LDL's carry cholesterol through the bloodstream. LDL is called bad cholesterol because high amounts can form plaques in the blood vessels, increasing risk for heart disease. Adult normal range is less than 100 mg/dL.","populationDescription":"Data was not collected nor analyzed for eight subjects in the Sleeve Gastrectomy Saxenda arm. Data was not collected nor analyzed for seven subjects in the Sleeve Gastrectomy Placebo arm. Data was not collected nor analyzed for thirteen subjects in the Roux-en-Y Gastric (RYGB).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"baseline and 36 months","groups":[{"id":"OG000","title":"Sleeve Gastrectomy Saxenda","description":"Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.\n\nSaxenda: Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will were randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36."},{"id":"OG001","title":"Sleeve Gastrectomy Placebo","description":"Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.\n\nPlacebos: Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG were randomized 1:1 at months 3 post-surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects remained on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36."},{"id":"OG002","title":"Roux-en-Y Gastric (RYGB)","description":"Subjects were recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.\n\nRYGB: Subjects were recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"25"}]}],"classes":[{"title":"baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"25"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"114","spread":"9"},{"groupId":"OG001","value":"101","spread":"11"},{"groupId":"OG002","value":"99","spread":"5"}]}]},{"title":"36 months","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"12"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"106","spread":"20"},{"groupId":"OG001","value":"68","spread":"1"},{"groupId":"OG002","value":"90","spread":"7"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Adverse Events were collected from baseline to end of study, approximately 36 months","eventGroups":[{"id":"EG000","title":"Sleeve Gastrectomy Saxenda","description":"Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.\n\nSaxenda: Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will were randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.","deathsNumAffected":0,"deathsNumAtRisk":12,"seriousNumAffected":1,"seriousNumAtRisk":12,"otherNumAffected":2,"otherNumAtRisk":12},{"id":"EG001","title":"Sleeve Gastrectomy Placebo","description":"Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.\n\nPlacebos: Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG were randomized 1:1 at months 3 post-surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects remained on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.","deathsNumAffected":0,"deathsNumAtRisk":9,"seriousNumAffected":0,"seriousNumAtRisk":9,"otherNumAffected":1,"otherNumAtRisk":9},{"id":"EG002","title":"Roux-en-Y Gastric (RYGB)","description":"Subjects were recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.\n\nRYGB: Subjects were recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.","deathsNumAffected":0,"deathsNumAtRisk":25,"seriousNumAffected":0,"seriousNumAtRisk":25,"otherNumAffected":14,"otherNumAtRisk":25}],"seriousEvents":[{"term":"Seizure","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":25}]}],"otherEvents":[{"term":"Hgb < 11.5 g/dL","organSystem":"Blood and lymphatic system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":25}]},{"term":"Nausea","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":12},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":9},{"groupId":"EG002","numEvents":14,"numAffected":14,"numAtRisk":25}]},{"term":"Vomiting","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":12},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":9},{"groupId":"EG002","numEvents":13,"numAffected":13,"numAtRisk":25}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Adrian Vella, M.D.","organization":"Mayo Clinic","email":"vella.adrian@mayo.edu","phone":"507-266-1387"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2023-05-02","uploadDate":"2024-09-24T14:20","filename":"Prot_SAP_001.pdf","size":415468}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09","submissionTracking":{"firstMcpInfo":{"postDateStruct":{"date":"2024-09-24","type":"ACTUAL"}}}},"conditionBrowseModule":{"meshes":[{"id":"D009765","term":"Obesity"},{"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":"D001836","term":"Body Weight Changes"}]},"interventionBrowseModule":{"meshes":[{"id":"D000069450","term":"Liraglutide"}],"ancestors":[{"id":"D052216","term":"Glucagon-Like Peptide 1"},{"id":"D004763","term":"Glucagon-Like Peptides"},{"id":"D052336","term":"Proglucagon"},{"id":"D005768","term":"Gastrointestinal Hormones"},{"id":"D006728","term":"Hormones"},{"id":"D006730","term":"Hormones, Hormone Substitutes, and Hormone Antagonists"}]}},"hasResults":true}