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PCORnet BariatricStudypSCANNER Meeting
AndrewOdegaard,PhDMPHUniversityofCalifornia,Irvine
10/13/16
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Overview
• Obesity• Treatmentforobesity• Bariatricsurgery• PCORnet BariatricStudy
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Obesity:AChronicDisease
• Overweightandobesityaredefinedas''abnormalorexcessivefataccumulationthatpresentsarisktohealth''.
• Thereisnogenerallyaccepteddefinitionofobesitybasedontotalbodyfat.Generally,researchershaveused>25%inmen,and>30-35%inwomen,ascut-pointstodefineobesity
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MeasuringandDefiningObesity
• Bodymassindex(BMI)istheratioofweighttoheight,calculatedasweight(kg)/height(m2)
• DefinitionforAsianpopulationsRecommendedtobedifferent
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TheObesityEpidemic:UnitedStates
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TheGlobalObesityEpidemic
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Obesity:Simple?
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UnderstandingObesity
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104PutativeCausesofObesity
• 1. agriculturalpolicies2. airconditioning,3. airpollution,4. antibioticusageatearlyage,5. arceanut chewing,6. artificial sweeteners,7. Asiantigermosquitos,8. assortativemating,9. beingasinglemother,10. birthbyC-section,11. built environment,12. celebritychefs,13. chemicaltoxins,(endocrinedisruptors)14. child maltreatment,15. compulsivebuying,16. competitivefoodsalesin schools,17. consumingskimmilkinpreschoolchildren,18. consumptionofpastriesandchocolate(inBurkinaFaso),19. declineinoccupationalphysicalactivity,20. delayedprenatalcare,21. delayedsatiety,22. depression23. drivingchildrentoschool24. eatingawayfromhome25. economicdevelopment(nutritiontransition)26.enteringintoaromanticrelationship,27. epigenetic factors,28.eradicationofHelicobacterpylori,29. family conflict,30. familydivorce,31. first-borninfamily,32. foodaddiction,33. fooddeserts,34. foodinsecurity,35. foodmarketingto children,36. foodoverproduction,37. friends,38. genetics,39. gestationaldiabetes,40. global foodsystem,(internationaltradepolicies)41. grilledfoods,42. gutmicrobioata,43. havingchildren,forwomen,44. heavyalcoholconsumption,45. homelaborsaving devices,46. hormones(insulin,glucagon,ghrelin),47. hunger-responsetofoodcues,48. highfructosecorn syrup,49. interpersonalviolence,50.lackoffamilymeals,51. lackofnutritionaleducation,52. lackofself-control,53. largeportionsizes,54. livingincrime-prone areas,55. loweducationallevelsforwomen,56. lowlevelsofphysical activity,57. lowVitaminDlevels,58. lowsocioeconomicstatus,59. marketeconomy,60. marryinginlaterlife61. maternalemployment,62. maternalobesity,63. maternalover-nutritionduringpregnancy,64. maternalsmoking,65. meatconsumption,66. menopause,67.mental disabilities,68.noorshorttermbreastfeeding,69. non-parentalchildcare70. outdooradvertising,71. overeating,72. participationinSupplementalNutritionAssistanceProgram(formerlyFoodStampProgram)73. perceivedweightdiscrimination,74. perceptionofneighborhoodsafety,75. physicaldisabilities,76. prenatal maternalexposuretonaturaldisasters,77. pooremotionalcoping78. sleepdeficits,79. skippingbreakfast,80. snacking,81. smoking cessation,82. spankingchildren,83. stairdesign84. stress,artificiallighting,airconditioning,85. sugar-sweetened beverages,86. tasteforfat87. transfats,88. transportationbycar,89. televisionsetinbedrooms90. televisionviewing,91. thyroiddysfunction92. vendingmachines,93. virus,94. weightgaininducing drugs,95. workinglonghours,96.NEWtoomuchhomework,97.NEWinsufficientbodyheat,98.NEWimaginingthesmelloffood,99.NEWdustcomponents,100.NEWlivingwithgrandparentsinChina,101.NEWestrogens,102.NEWthermogenicadipocytes,103.NEWprenatalexposuretocigarettesmoke,104.NEWstartingcollege. -
• http://www.downeyobesityreport.com/2015/10/
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ConsequencesofObesity
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TreatmentforObesity
• 1)Losingweightviabehavioralapproaches
• 2)Medications
• 3)Weightlosssurgery(i.e.bariatricsurgery)
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CandidatesforBariatricSurgery
• Qualificationsforbariatricsurgeryinmostareasinclude:
• BMI≥40,ormorethan100poundsoverweight
• BMI≥35andatleasttwoobesity-relatedco-morbiditiessuchastypeIIdiabetes,hypertension,sleepapneaandotherrespiratorydisorders,non-alcoholicfattyliverdisease,osteoarthritis,lipidabnormalities,gastrointestinaldisorders,orheartdisease
• Inabilitytoachieveahealthyweightlosssustainedforaperiodoftimewithpriorweightlossefforts
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TypesofBariatricSurgery:TheRoux-en-YGastricBypass
OverviewThe Roux-en-Y gastric bypass procedure involves creating a stomach pouch out of a small portion of the stomach and attaching it directly to the small intestine, bypassing a large part of the stomach and duodenum. Not only is the stomach pouch too small to hold large amounts of food, but by skipping the duodenum, fat absorption is substantially reduced https://medlineplus.gov/ency/imagepages/19268.htm
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TypesofBariatricSurgery:SleeveGastrectomy
The Laparoscopic Sleeve Gastrectomy – often called the sleeve – is performed by removing approximately 80 percent of the stomach. The remaining stomach is a tubular pouch that resembles a banana
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TypesofBariatricSurgery:AdjustableGastricBand
The Adjustable Gastric Band – often called the band – involves an inflatable band that is placed around the upper portion of the stomach, creating a small stomach pouch above the band, and the rest of the stomach below the band.
http://asmbs.org/patients/bariatric-surgery-procedures
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PCORnet Bariatric Study:Overview of Scientific AimsThe main goal is to provide accurate estimates of the 1-, 3-, and 5-year benefits and risks of the three main surgical treatment options for severe obesity§ Roux-en-y gastric bypass (RYGB)§ Adjustable gastric banding (AGB)§ Sleeve gastrectomy (SG)
Focus on the outcomes that have been shown to be most important to adults and adolescents with severe obesity: § Weight loss, § Improvement in diabetes,§ Risk of adverse events§ (Also weight loss and diabetes were specifically named in the
PFA)
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Three Specific AimsAim 1: Aim 1: To what extent does weight loss and weight regain differ across the three bariatric surgical procedures (RYGB, AGB, and SG) at 1, 3, and 5 years? § Sub Aim: explore heterogeneity by race/ethnicity, pre-op BMI, age
Aim 2: To what extent does bariatric surgery lead to improvements in diabetes risk at 1, 3, and 5 years?§ Rate of remission from diabetes (A1C <6.5%, off DM medications)§ Rate of incident diabetes among those without it at baseline
Aim 3: What is the frequency of adverse events following different bariatric surgical procedures at 1, 3, and 5 years?§ Severe adverse events, including hospitalization, re-operations§ Mortality
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PBS Timeline - Data Collection from CDM
Date ItemCOMPLETE Wave 1 SSDC Distribution (DRN OC Group 1 DMs only)
and output returned9/28/16 Aim 1 Individual Level Query distribution (DRN OC
Group “Research Ready”; have usable study data per SSDC)
11/1/16 Wave 2 SSDC distributionNovember/December2016
Decisions on DataMarts to participate in PBS Year 2
January 2017 Aim 1 Aggregate Level Query Distribution Feb 2017 – Dec 2017 Aims 2 and 3: Individual level and aggregate level Query
distribution
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pSCANNER DataMarts Participating
Budgeted: UC Irvine, UCLA, UCSD, VA VINCIDataMarts sent SSDC Wave 1 and PBS Aim 1 Individual-level query: UC Irvine, UCLA
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VeryPreliminaryResults
NumberofuniquepatientswithavalidbariatriccodeinanIPsettingwhomeetallinclusioncriteriaUCI:510UCLA:1393
NumberofadultswithaBMIintheyearbeforesurgeryUCI:298(59%)UCLA:244(18%)
NumberofadultswithaBMI>=35inyearbeforesurgeryUCI:227(76%ofthosewithaBMI);189SG;22RYGB;16AGBUCLA:211(86%ofthosewithaBMI);169SG;41RYGB;0AGB
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VeryPreliminaryResults
AmongthosewithaBMI>=35inyearbeforesurgery,numberwithanydiabetesdiagnosiscodeintheyearbeforesurgery:UCI:62UCLA:56
AmongthosewithaBMI>=35inyearbeforesurgery,whatnumberhaveBMIat6-18monthsaftersurgeryUCI:130(57%)UCLA:166(79%)
AmongthosewithaBMI>=35inyearbeforesurgery,whatnumberhaveBMIat30-42monthsaftersurgeryUCI:43UCLA:0
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Acknowledgements:StudyPrincipalInvestigators
• DavidArterburn,clinicalinvestigator,PORTAL[leadsite]• Bariatricsurgeryresearcher• Leaderofseveralmultisitebariatricstudies• GroupHealthSite-PIforPORTAL
• KathleenMcTigue,clinicalinvestigator,PaTH• Obesityresearcher• Lead,PaTHWeightCohort• Co-chairoftheBariatricTopicBriefTeam
• NeelyWilliams,patientpartner,Mid-South• Communityengagementleader• Patientco-investigator,Mid-South• Bariatricsurgerypatient
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Acknowledgements
• UCIteam• RoniBracha andRobynn Zen