{ "FullStudy":{ "Rank":218095, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512797", "OrgStudyIdInfo":{ "OrgStudyId":"AAAO1107" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"0000048421", "SecondaryIdType":"Other Grant/Funding Number", "SecondaryIdDomain":"Merck & Co., Inc" } ] }, "Organization":{ "OrgFullName":"Columbia University", "OrgClass":"OTHER" }, "BriefTitle":"Treatment of Diabetes After Gastric Bypass With Sitagliptin", "OfficialTitle":"A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Assess Efficacy, Safety and Tolerability of Sitagliptin Phosphate 100 mg as Treatment for Recurrent, Persistent or Newly Diagnosed Type 2 Diabetes After Gastric Bypass", "Acronym":"LAF33" }, "StatusModule":{ "StatusVerifiedDate":"January 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"July 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"August 2016", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"August 2016", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"December 1, 2017", "ResultsFirstSubmitQCDate":"February 20, 2018", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"February 23, 2018", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"January 7, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 22, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor-Investigator", "ResponsiblePartyInvestigatorFullName":"Blandine Laferrere", "ResponsiblePartyInvestigatorTitle":"Associate Professor of Medicine, Columbia University", "ResponsiblePartyInvestigatorAffiliation":"Columbia University" }, "LeadSponsor":{ "LeadSponsorName":"Blandine Laferrere", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Merck Sharp & Dohme Corp.", "CollaboratorClass":"INDUSTRY" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes", "IsUSExport":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to assess whether Januvia (sitagliptin phosphate 100mg) is safe and effective for the treatment of Type 2 Diabetes in patients who have had Gastric Bypass.", "DetailedDescription":"Januvia (sitagliptin phosphate 100mg) is an FDA approved medication for the treatment of Type 2 Diabetes. Sitagliptin works by inhibiting the Dipeptidyl peptidase-4 enzyme, resulting in increased active glucagon-like peptide-1 (GLP-1) levels. GLP-1 is an incretin which increases post-prandial insulin secretion. Because Gastric Bypass has also been shown to increase GLP-1 levels, this study seeks to determine the additional effect of DDP-4 inhibition on glucose control in patients who have elevated incretin levels post Gastric Bypass. The study will also assess if Januvia (Sitagliptin phosphate) is safe and well tolerated in patients after Gastric Bypass.\n\nRecruitment and data collection for this study was started at St. Luke's Hospital in New York, NY and later moved to Columbia University Medical Center in New York, NY." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Type 2 Diabetes Mellitus" ] }, "KeywordList":{ "Keyword":[ "Januvia", "Sitagliptin", "Diabetes", "Gastric-Bypass" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"37", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Sitagliptin phosphate", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Sitagliptin phosphate" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"1 Placebo pill / day PO once a day for 4-5 weeks", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Sitagliptin phosphate", "InterventionDescription":"100 mg/day orally", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Sitagliptin phosphate" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Januvia" ] } },{ "InterventionType":"Other", "InterventionName":"Placebo", "InterventionDescription":"1 Placebo Pill per day", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change in Postprandial Glucose Levels After Mixed Meal Test", "PrimaryOutcomeDescription":"Glucose levels were measured in study participants while fasting and periodically over 3 hours after drinking a 200 kcal mixed meal test, before and after intervention (Sitagliptin or Placebo).", "PrimaryOutcomeTimeFrame":"Baseline and ~4 weeks" },{ "PrimaryOutcomeMeasure":"Change in Area Under the Curve (AUC) Glucose Levels After Mixed Meal Test", "PrimaryOutcomeDescription":"Glucose levels were measured in study participants while fasting and periodically over 3 hours after drinking a 200 kcal mixed meal test, before and after intervention (Sitagliptin or Placebo). AUC was measured by trapezoidal method.", "PrimaryOutcomeTimeFrame":"Baseline and ~4 weeks" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Effect of Sitagliptin vs Placebo on Satiety in Patients With Type 2 Diabetes After Gastric Bypass Surgery", "SecondaryOutcomeDescription":"Satiety levels were measured in study participants while they were fasting and periodically over a three hour period after drinking a 200 kcal meal drink, before and after intervention via a Visual Analog Scale. Participants were asked to mark on a 0 to 150 millimeter scale their response to the following question: \"How full do you feel right now?\" with lower scores indicating \"not full at all\" and higher scores indicating \"extremely full.\"", "SecondaryOutcomeTimeFrame":"Baseline and ~4 weeks" },{ "SecondaryOutcomeMeasure":"Occurrence of Side Effects In Relation to Sitagliptin", "SecondaryOutcomeDescription":"Side effects to Sitagliptin or Placebo were measured in study participants via Sigstad score questionnaire, while fasting and periodically during a 3 hour period after drinking a 200 kcal meal drink, before and after intervention. The Sigstad scoring system is based on the participants report of the occurrence of 16 symptoms suggestive of the dumping syndrome. Each symptom is given a different score. For example, desire to sit down (+4), breathlessness (+3), dizziness (+2), nausea (+1), vomiting (-4) etc.The scale can range from -5 to 34. Scores greater than or equal to 7, after glucose intake, are considered diagnostic of dumping syndrome.", "SecondaryOutcomeTimeFrame":"6 weeks" },{ "SecondaryOutcomeMeasure":"Active GLP-1", "SecondaryOutcomeDescription":"Active GLP-1 (Fasting and during a Mixed Meal Test). The Change in Fasting Active GLP-1 refers to the change in fasting active GLP-1 from pre-intervention time point to post-intervention time point. The Change in Peak Active GLP-1 refers to the change in the peak active GLP-1 level from the pre-intervention time point to post-intervention time point.", "SecondaryOutcomeTimeFrame":"Pre-Intervention and Post-Intervention" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMust be a resident of the NYC metropolitan area or be able to come for emergency unscheduled and regular weekly meetings in Manhattan.\nHbA1c ≥ 6.5% and ≤ 8.5 % or a fasting glucose ≥ 126 mg/dL or a random glucose ≥ 200 mg/dL at least 12 months after GBP surgery confirmed by central laboratory.\nSubject is capable and willing to give informed consent.\nSubject is otherwise in good general health, based on medical history and physical examination.\nSubject is a non smoker for at least 6 months prior to study start\nFemale subjects of child bearing potential must use oral, injected or implanted hormonal methods of contraception from at least the commencement of their last normal period prior to the first administration of the challenge agent. Subjects using hormonal contraception should use a barrier method in addition from the first administration of challenge agent until their next normal period following the end of the study.\n\nExclusion Criteria:\n\nHistory of type 1 diabetes\nFemale subject is pregnant or breastfeeding.\nRecent (< 30 days) or simultaneous participation in another clinical trial.\nAny situation that can compromise the study, including serious illness or a predictable lack of cooperation from the subject.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"70 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Blandine Laferrere, MD", "OverallOfficialAffiliation":"New York Obesity Nutrition Research Center", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"New York Obesity Nutrition Research Center, Columbia University", "LocationCity":"New York", "LocationState":"New York", "LocationZip":"10032", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"New York Obesity Nutrition Research Center", "SeeAlsoLinkURL":"http://www.nyorc.org/" } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"Undecided" } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"37 participants were enrolled, however only 32 participated in study procedures and demographic information collection.", "FlowRecruitmentDetails":"Recruitment for this study took place from July 2012-July 2016. Recruitment and data collection for this study was started at St. Luke's Hospital in New York, NY and later moved to Columbia University Medical Center in New York, NY.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Sitagliptin Phosphate", "FlowGroupDescription":"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks\n\nSitagliptin phosphate: 100 mg/day orally" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Placebo", "FlowGroupDescription":"1 Placebo pill / day PO once a day for 4-5 weeks\n\nPlacebo: 1 Placebo Pill per day" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"16" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"16" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"16" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"16" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Sitagliptin Phosphate", "BaselineGroupDescription":"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks\n\nSitagliptin phosphate: 100 mg/day orally" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Placebo", "BaselineGroupDescription":"1 Placebo pill / day PO once a day for 4-5 weeks\n\nPlacebo: 1 Placebo Pill per day" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"16" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"16" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"32" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"54.2", "BaselineMeasurementSpread":"9.0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"58.4", "BaselineMeasurementSpread":"7.0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"56.3", "BaselineMeasurementSpread":"8.2" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"15" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"14" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"29" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"3" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race/Ethnicity, Customized", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Caucasian", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8" } ] } },{ "BaselineCategoryTitle":"Hispanic White", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"10" } ] } },{ "BaselineCategoryTitle":"Hispanic Black", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"5" } ] } },{ "BaselineCategoryTitle":"African-American", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"9" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"BMI", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"kg/m2", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"32.70", "BaselineMeasurementSpread":"5.22" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"36.12", "BaselineMeasurementSpread":"7.69" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"34.41", "BaselineMeasurementSpread":"6.69" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"HbA1c", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"%", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7.46", "BaselineMeasurementSpread":"0.78" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6.96", "BaselineMeasurementSpread":"0.70" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"7.21", "BaselineMeasurementSpread":"0.77" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Time since Roux-en-Y gastric bypass surgery", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5.56", "BaselineMeasurementSpread":"3.77" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5.57", "BaselineMeasurementSpread":"2.80" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"5.56", "BaselineMeasurementSpread":"3.27" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Type 2 Diabetes Mellitus duration prior to Roux-en-Y gastric bypass surgery", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"12.9", "BaselineMeasurementSpread":"11.0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"12.9", "BaselineMeasurementSpread":"9.3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"12.9", "BaselineMeasurementSpread":"10.0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Type 2 Diabetes Mellitus remission duration prior to study", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2.72", "BaselineMeasurementSpread":"3.10" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2.16", "BaselineMeasurementSpread":"2.74" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2.44", "BaselineMeasurementSpread":"2.89" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Maximum Weight before Roux-en-Y gastric bypass surgery", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"kg", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"122.45", "BaselineMeasurementSpread":"19.0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"132.89", "BaselineMeasurementSpread":"24.23" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"127.7", "BaselineMeasurementSpread":"22.1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Weight at Roux-en-Y gastric bypass", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"kg", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"117.5", "BaselineMeasurementSpread":"20.4" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"130.23", "BaselineMeasurementSpread":"24.6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"123.9", "BaselineMeasurementSpread":"23.1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Nadir weight after Roux-en-Y gastric bypass", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"kg", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"73.51", "BaselineMeasurementSpread":"17.52" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"82.93", "BaselineMeasurementSpread":"13.38" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"78.22", "BaselineMeasurementSpread":"16.06" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Current Weight", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"kg", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"85.98", "BaselineMeasurementSpread":"15.21" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"95.82", "BaselineMeasurementSpread":"19.71" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"90.90", "BaselineMeasurementSpread":"18.02" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Current weight loss since Roux-en-Y gastric bypass", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"kg", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"31.53", "BaselineMeasurementSpread":"11.90" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"34.47", "BaselineMeasurementSpread":"13.91" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"33.00", "BaselineMeasurementSpread":"12.82" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Weight regain from nadir weight", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"kg", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"12.73", "BaselineMeasurementSpread":"10.70" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"12.96", "BaselineMeasurementSpread":"10.94" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"12.84", "BaselineMeasurementSpread":"10.64" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Number of oral type 2 diabetes mellitus medications prior to Roux-en-Y gastric bypass", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"number of medications", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1.88", "BaselineMeasurementSpread":"0.89" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1.75", "BaselineMeasurementSpread":"0.93" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1.81", "BaselineMeasurementSpread":"0.90" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Participants on insulin prior to RYGB", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"20" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Participants on insulin at time of study", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"7" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Total Cholesterol", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"mg/dL", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"172.0", "BaselineMeasurementSpread":"41.5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"151.78", "BaselineMeasurementSpread":"32.67" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"161.1", "BaselineMeasurementSpread":"37.67" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Triglycerides", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"mg/dL", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"147.3", "BaselineMeasurementSpread":"123.9" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"124.7", "BaselineMeasurementSpread":"50.2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"135.1", "BaselineMeasurementSpread":"90.6" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"High-density lipoprotein", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"mg/dL", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"54.83", "BaselineMeasurementSpread":"15.21" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"59.21", "BaselineMeasurementSpread":"29.39" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"57.19", "BaselineMeasurementSpread":"23.58" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Low-density lipoprotein", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"mg/dL", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"89.18", "BaselineMeasurementSpread":"39.92" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"76.79", "BaselineMeasurementSpread":"28.24" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"82.24", "BaselineMeasurementSpread":"33.70" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Systolic blood pressure", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"mm Hg", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"124.8", "BaselineMeasurementSpread":"21.23" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"119.1", "BaselineMeasurementSpread":"14.4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"122.23", "BaselineMeasurementSpread":"18.4" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Diastolic blood pressure", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"mm Hg", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"74.69", "BaselineMeasurementSpread":"12.26" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"69.77", "BaselineMeasurementSpread":"11.05" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"72.48", "BaselineMeasurementSpread":"11.79" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change in Postprandial Glucose Levels After Mixed Meal Test", "OutcomeMeasureDescription":"Glucose levels were measured in study participants while fasting and periodically over 3 hours after drinking a 200 kcal mixed meal test, before and after intervention (Sitagliptin or Placebo).", "OutcomeMeasurePopulationDescription":"All patients completed study in both arms.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"mmol/L", "OutcomeMeasureTimeFrame":"Baseline and ~4 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Sitagliptin Phosphate", "OutcomeGroupDescription":"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks\n\nSitagliptin phosphate: 100 mg/day orally" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"1 Placebo pill / day PO once a day for 4-5 weeks\n\nPlacebo: 1 Placebo Pill per day" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"16" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Pre-Intervention Fasting Glucose", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.10", "OutcomeMeasurementSpread":"1.74" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.52", "OutcomeMeasurementSpread":"1.21" } ] } } ] } },{ "OutcomeClassTitle":"Post-Intervention Fasting Glucose", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.44", "OutcomeMeasurementSpread":"1.25" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.39", "OutcomeMeasurementSpread":"1.23" } ] } } ] } },{ "OutcomeClassTitle":"Pre-Intervention 120 minute glucose", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.51", "OutcomeMeasurementSpread":"1.91" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7.01", "OutcomeMeasurementSpread":"1.38" } ] } } ] } },{ "OutcomeClassTitle":"Post-Intervention 120 minute glucose", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.79", "OutcomeMeasurementSpread":"1.65" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.97", "OutcomeMeasurementSpread":"1.47" } ] } } ] } },{ "OutcomeClassTitle":"Pre-Intervention Average Glucose during MMT", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.55", "OutcomeMeasurementSpread":"1.95" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.12", "OutcomeMeasurementSpread":"1.14" } ] } } ] } },{ "OutcomeClassTitle":"Post-Intervention Average Glucose during MMT", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.84", "OutcomeMeasurementSpread":"1.47" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7.86", "OutcomeMeasurementSpread":"1.04" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Power analysis. Based on the effect of DPP-4 inhibitors in non-operated subjects with type 2 diabetes, showing a significant decrease in 120’ post-prandial glucose by 1.67 mmol/L ± 0.98 mmol/L after a MMT, we estimated that a sample size of 16 subjects per group will show post-prandial glucose differences between placebo and sitagliptin group with α = 0.05 for a power > 90%.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.028", "OutcomeAnalysisPValueComment":"P-value refers to paired t-test comparing pre-intervention and post-intervention timepoints in Sitagliptin group.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change in Area Under the Curve (AUC) Glucose Levels After Mixed Meal Test", "OutcomeMeasureDescription":"Glucose levels were measured in study participants while fasting and periodically over 3 hours after drinking a 200 kcal mixed meal test, before and after intervention (Sitagliptin or Placebo). AUC was measured by trapezoidal method.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"mmol/L/min", "OutcomeMeasureTimeFrame":"Baseline and ~4 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Sitagliptin Phosphate", "OutcomeGroupDescription":"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks\n\nSitagliptin phosphate: 100 mg/day orally" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"1 Placebo pill / day PO once a day for 4-5 weeks\n\nPlacebo: 1 Placebo Pill per day" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"16" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Pre-Intervention Glucose AUC", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.31", "OutcomeMeasurementSpread":"1.92" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7.96", "OutcomeMeasurementSpread":"1.20" } ] } } ] } },{ "OutcomeClassTitle":"Post-Intervention Glucose AUC", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.67", "OutcomeMeasurementSpread":"1.59" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7.75", "OutcomeMeasurementSpread":"1.16" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Effect of Sitagliptin vs Placebo on Satiety in Patients With Type 2 Diabetes After Gastric Bypass Surgery", "OutcomeMeasureDescription":"Satiety levels were measured in study participants while they were fasting and periodically over a three hour period after drinking a 200 kcal meal drink, before and after intervention via a Visual Analog Scale. Participants were asked to mark on a 0 to 150 millimeter scale their response to the following question: \"How full do you feel right now?\" with lower scores indicating \"not full at all\" and higher scores indicating \"extremely full.\"", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"mm", "OutcomeMeasureTimeFrame":"Baseline and ~4 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Sitagliptin Phosphate", "OutcomeGroupDescription":"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks\n\nSitagliptin phosphate: 100 mg/day orally" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"1 Placebo pill / day PO once a day for 4-5 weeks\n\nPlacebo: 1 Placebo Pill per day" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"16" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Pre-Intervention fasting satiety level", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"51.94", "OutcomeMeasurementSpread":"87.40" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"49.06", "OutcomeMeasurementSpread":"39.36" } ] } } ] } },{ "OutcomeClassTitle":"Post-Intervention fasting satiety level", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"22.38", "OutcomeMeasurementSpread":"22.03" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"58.50", "OutcomeMeasurementSpread":"113.23" } ] } } ] } },{ "OutcomeClassTitle":"Pre-Intervention 180 minute glucose", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"37.81", "OutcomeMeasurementSpread":"40.95" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"50.50", "OutcomeMeasurementSpread":"59.37" } ] } } ] } },{ "OutcomeClassTitle":"Post-Intervention 180 minute glucose", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"43.69", "OutcomeMeasurementSpread":"43.85" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"103.75", "OutcomeMeasurementSpread":"198.35" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Occurrence of Side Effects In Relation to Sitagliptin", "OutcomeMeasureDescription":"Side effects to Sitagliptin or Placebo were measured in study participants via Sigstad score questionnaire, while fasting and periodically during a 3 hour period after drinking a 200 kcal meal drink, before and after intervention. The Sigstad scoring system is based on the participants report of the occurrence of 16 symptoms suggestive of the dumping syndrome. Each symptom is given a different score. For example, desire to sit down (+4), breathlessness (+3), dizziness (+2), nausea (+1), vomiting (-4) etc.The scale can range from -5 to 34. Scores greater than or equal to 7, after glucose intake, are considered diagnostic of dumping syndrome.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on Sigstad scale", "OutcomeMeasureTimeFrame":"6 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Sitagliptin Phosphate", "OutcomeGroupDescription":"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks\n\nSitagliptin phosphate: 100 mg/day orally" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"1 Placebo pill / day PO once a day for 4-5 weeks\n\nPlacebo: 1 Placebo Pill per day" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"16" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Pre-Intervention Average Sigstad Score", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.15", "OutcomeMeasurementSpread":"1.97" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5.58", "OutcomeMeasurementSpread":"3.41" } ] } } ] } },{ "OutcomeClassTitle":"Post-Intervention Average Sigstad Score", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.24", "OutcomeMeasurementSpread":"2.34" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.40", "OutcomeMeasurementSpread":"3.10" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Active GLP-1", "OutcomeMeasureDescription":"Active GLP-1 (Fasting and during a Mixed Meal Test). The Change in Fasting Active GLP-1 refers to the change in fasting active GLP-1 from pre-intervention time point to post-intervention time point. The Change in Peak Active GLP-1 refers to the change in the peak active GLP-1 level from the pre-intervention time point to post-intervention time point.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"pmol/L", "OutcomeMeasureTimeFrame":"Pre-Intervention and Post-Intervention", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Sitagliptin Phosphate", "OutcomeGroupDescription":"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks\n\nSitagliptin phosphate: 100 mg/day orally" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"1 Placebo pill / day PO once a day for 4-5 weeks\n\nPlacebo: 1 Placebo Pill per day" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"16" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Change in Fasting Active GLP-1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.45", "OutcomeMeasurementSpread":"2.59" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.22", "OutcomeMeasurementSpread":"0.88" } ] } } ] } },{ "OutcomeClassTitle":"Change in Peak Active GLP-1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"22.08", "OutcomeMeasurementSpread":"15.46" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.97", "OutcomeMeasurementSpread":"10.44" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Over 6 weeks (the time period a participant was involved in the study).", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Sitagliptin Phosphate", "EventGroupDescription":"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks\n\nSitagliptin phosphate: 100 mg/day orally", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"16", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"16", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"16" },{ "EventGroupId":"EG001", "EventGroupTitle":"Placebo", "EventGroupDescription":"1 Placebo pill / day PO once a day for 4-5 weeks\n\nPlacebo: 1 Placebo Pill per day", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"16", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"16", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"16" } ] } }, "MoreInfoModule":{ "LimitationsAndCaveats":{}, "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictiveAgreement":"No" }, "PointOfContact":{ "PointOfContactTitle":"Dr. Blandine Laferrere", "PointOfContactOrganization":"Columbia University Medical Center", "PointOfContactEMail":"bbl14@columbia.edu", "PointOfContactPhone":"212-851-5562" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000068900", "InterventionMeshTerm":"Sitagliptin Phosphate" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000007004", "InterventionAncestorTerm":"Hypoglycemic Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000054795", "InterventionAncestorTerm":"Incretins" },{ "InterventionAncestorId":"D000006728", "InterventionAncestorTerm":"Hormones" },{ "InterventionAncestorId":"D000006730", "InterventionAncestorTerm":"Hormones, Hormone Substitutes, and Hormone Antagonists" },{ "InterventionAncestorId":"D000054873", "InterventionAncestorTerm":"Dipeptidyl-Peptidase IV Inhibitors" },{ "InterventionAncestorId":"D000011480", "InterventionAncestorTerm":"Protease Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M335", "InterventionBrowseLeafName":"Sitagliptin Phosphate", "InterventionBrowseLeafAsFound":"Sitagliptin phosphate", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M8637", "InterventionBrowseLeafName":"Hypoglycemic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M26492", "InterventionBrowseLeafName":"Incretins", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8372", "InterventionBrowseLeafName":"Hormones", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8371", "InterventionBrowseLeafName":"Hormone Antagonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M26544", "InterventionBrowseLeafName":"Dipeptidyl-Peptidase IV Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M12926", "InterventionBrowseLeafName":"Protease Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M18192", "InterventionBrowseLeafName":"HIV Protease Inhibitors", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Hypo", "InterventionBrowseBranchName":"Hypoglycemic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000003920", "ConditionMeshTerm":"Diabetes Mellitus" },{ "ConditionMeshId":"D000003924", "ConditionMeshTerm":"Diabetes Mellitus, Type 2" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000044882", "ConditionAncestorTerm":"Glucose Metabolism Disorders" },{ "ConditionAncestorId":"D000008659", "ConditionAncestorTerm":"Metabolic Diseases" },{ "ConditionAncestorId":"D000004700", "ConditionAncestorTerm":"Endocrine System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M5702", "ConditionBrowseLeafName":"Diabetes Mellitus, Type 2", "ConditionBrowseLeafAsFound":"Type 2 Diabetes", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5698", "ConditionBrowseLeafName":"Diabetes Mellitus", "ConditionBrowseLeafAsFound":"Diabetes", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10222", "ConditionBrowseLeafName":"Metabolic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M23990", "ConditionBrowseLeafName":"Glucose Metabolism Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6445", "ConditionBrowseLeafName":"Endocrine System Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "ConditionBrowseBranchAbbrev":"BC19", "ConditionBrowseBranchName":"Gland and Hormone Related Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }