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Federation Taskforce onEpidemiologyandPrevention Arq Bras Metab. Endocrinol 2011;55/6 wasfirstpublished inDiabeticMedicine.2011, *Thisarticle Volume 28,Issue6;628-642. cirurgia bariátricadevemserdesenvolvidas parapacientes comdiabetestipo2eIMCde35kg/m nuos, alémdeprocedimentoscirúrgicossegurosepadronizados. As diretrizes nacionaisparaa uma avaliaçãomultidisciplinar, umprocessoamplodeeducaçãodopacienteecuidados contí- maiores. Osprocedimentosdevemserexecutadospormeio dediretrizes aceitaserequerem tratamento comterapiasmedicamentosas,especialmentena presença deoutrascomorbidades pessoas comdiabetestipo2eobesidadequenãoconsigam atingirasmetasrecomendadas de obesos comdiabetestipo2. A cirurgiapodeserconsideradaumtratamentoapropriadopara seguroedebomcusto-benefícioparapacientes diabetes tipo2.Elaéumtratamentoefetivo, noe controle glicêmico em pacientes com obesidade grave gerar uma melhora significativa à cirurgia,quandoindicada,eidentificarprioridadesparaapesquisa. Acirurgiabariátricapode e sugeririntervençõesparamudançasdaspolíticasdesaúdequegarantam equidadedeacesso recomendações práticasparaaseleçãodospacientes;identificarbarreiras aoacessoàcirurgia específicosforam:desenvolvermento eprevençãododiabetestipo2emobesos.Osobjetivos pública pararevisaropapelcorreto dacirurgiaeoutrasintervençõesgastrointestinais notrata- grupo detrabalhocomdiabetologistas,endocrinologistas,cirurgiõeseespecialistasemsaúde A Força-Tarefa paraEpidemiologiaePrevenção daInternationalDiabetesFederation reuniuum RESUMO need tobedevelopedforpeoplewith Type 2diabetesandaBMIof35kg/m as wellsafeandstandardized surgicalprocedures.Nationalguidelinesforbariatricsurgery patienteducationandongoingcare, ciplinary assessmentfortheprocedure,comprehensive procedures mustbeperformedwithinacceptedguidelinesandrequireappropriatemultidis- targets withmedicaltherapies,especiallyinthepresenceofothermajorco-morbidities. The treatment forpeoplewith Type 2diabetesandobesitynotachieving recommendedtreatment and cost-effective therapyforobese Type 2diabetes. Surgerycanbeconsideredanappropriate prove glycaemic control in severely obese patients with . It is an effective, safe when indicated;andtoidentifyprioritiesforresearch. Bariatricsurgery cansignificantlyim- and suggestinterventionsforhealthpolicychanges thatensureequitable accesstosurgery cal recommendationsforcliniciansonpatientselection;toidentifybarriers tosurgicalaccess in thetreatmentandpreventionof Type 2diabetes. The specificgoalswere:todeveloppracti- health experts toreviewtheappropriateroleofsurgeryandothergastrointestinal interventions convened aconsensusworking groupofdiabetologists,endocrinologists,surgeonsandpublic The InternationalDiabetesFederation Taskforce onEpidemiologyandPrevention ofDiabetes Abstract Dixon JB sobre odiabetes tipo2emobesos Cirurgia bariátrica: umacomunicação daIDF for obese Type 2diabetes* :Bariatric anIDFstatement Endocrinol Metab. 2011;55(6):367-82 ou mais. Arq BrasEndocrinolMetab. 2011;55(6):367-82 1 , ZimmetP 1 ,KG Alberti 2 , RubinoF 3 , onbehalfoftheInternational 2 ormore. Arq Bras 2

London, London, UK Victoria, Australia Institute, Melbourne, 3 2 1 article original Accepted onJun/20/2011 Received onMay/17/2011 onlineopen#OnlineOpen_Terms http://wileyonlinelibrary.com/ and Conditionssetoutat in accordancewiththe Terms Re-use ofthisarticleispermitted [email protected] USA Road, Melbourne, Victoria 3004, Institute, Level 4,99Commercial Baker IDI, HeartandDiabetes Paul Zimmet Correspondence to: New York, NY, USA College ofCornellUniversity, Weill Cornell Medical Imperial College Baker IDIHeartandDiabetes 367

Copyright© ABE&M todos os direitos reservados. Copyright© ABE&M todos os direitos reservados. 368 T T Executiv Summary T Review critria IDF positionstatement- identified were English-language,full-textpapers. identified were Type 2diabetes.Allpapers ces beingdevelopedtotreat and devi- procedures and novel gastrointestinal control onglycaemic ofthesurgery and non-weightlosseffects weightloss alsoexplored Type 2diabetes. Thegroup therapy for peoplewithobesityand standard to current inrelation ness oftheestablishedbariatricprocedures available evidenceforefficacy,- safetyandcosteffective synthesizedthe in adultsandadolescents.Thegroup ofobesityanddiabetes clinical trialsforthetreatment andhigh-quality oftheliterature nes, systematicreviews guideli- ofnationalandinternational 2010, intheareas • • • • • • • • • • • ext box2:Bariatricsurgery ext box1:Background be reducedby2.5kg/m In Asian,andsomeotherethnicitiesofincreasedrisk,BMIactionpointsmay major cardiovasculardiseaseriskfactors controlled byoptimalmedicalregimen,especiallyinthepresenceofother procedures areavailable tothosemostlikelybenefit mayberequiredtoensurethatthe Strategies toprioritizeaccesssurgery effective andcost-effectivetreatmentoptions healthcare system,shouldnotactasabarrier totheprovisionofclinically Societal prejudicesaboutsevereobesity, whichalsoexistwithinthe Clinically severeobesityisacomplexand chronicmedicalcondition. and aBMIof35kg/m shouldbeanacceptedoptioninpeoplewho haveTypeSurgery 2diabetes therapies, especiallywhenthereareothermajorco-morbidities and obesitynotachievingrecommendedtreatmenttargetswithmedical isanappropriatetreatmentforpeople withTypeBariatric surgery 2diabetes approach totreatingthedisease avoiding theneedformedicationsandprovidingapotentiallycost-effective severely obesepatients,oftennormalizingbloodglucoselevels,reducingor constitutepowerfuloptionstoamelioratediabetesin (‘bariatric surgery’), on thegastrointestinaltract,originallydevelopedtotreatmorbidobesity In additiontobehaviouralandmedicalapproaches,varioustypesofsurgery aspossible as potentanarmamentariumoftherapeuticinterventions Faced withtheescalatingglobaldiabetescrisis,healthcareprovidersrequire be availableforpeoplewhohavedevelopedType 2diabetes andType 2diabetes.Atthesametime,effectivetreatmentmustalso Continuing population-basedeffortsareessentialtopreventtheonsetof governments, healthcaresystemsandthemedicalcommunity major globalpublichealthissueanddemandsurgentattentionfrom The dramaticriseintheprevalenceofobesityanddiabeteshasbecomea mortality complex metabolicdysfunctionsthatincreasetheriskformorbidityand Obesity andType 2diabetesareseriouschronicdiseasesassociatedwith with aBMIbetween30and35kg/m shouldbeconsideredasanalternativetreatment optioninpatients Surgery on bariatric focusing literature reviewed he workinggroup surgery publishedbetween1991and surgery 2 ormore 2 2 when diabetescannotbeadequately people with Type 2 diabetes, including the metabolic andmanage. control tegies atmanylevelstoprevent, stra- iscomplex(4)andwillrequire (2). Theproblem diabetes hasbecomeamajor globalpublichealthissue lic dysfunction(3). tion, obesity,- byitself,generatessimilarcardio-metabo inflammationandhaemato-rheology.ve stress, Inaddi- other dysfunctions involving lipid metabolism, oxidati- in hyperglycaemia, but is also associated with multiple andactionresults inadequate insulinproduction from suchcomplications.Thediseaseresults sult from - andmorbidityindiabetesre mortality ase). Premature andperipheralvasculardise- cerebro- extensive cardio-, and more (premature andmacrovascular neuropathy) and nephropathy (retinopathy; ge: both microvascular Introductin threats ofthe21 threats publichealth betes isloomingasoneofthegreatest halfbillionathighrisk.Dia- 2030 (2),withafurther tly worldwide.Thisissettoescalate438millionby - 285millionpeoplewithdiabetescurren are that there DiabetesFederation(IDF)suggest by theInternational global predictions tible genotypes(1).Themostrecent cess toattractivecalorie-densefoodsactingonsuscep- behaviourandeasierac- sedentary favours increasing matically, that driven by an ‘obesogenic’ environment ofType 2diabetesisrisingdra - The globalprevalence Why isthispositionstatementneeded? • • • • • • There is increasing evidencethatthehealthofobese isincreasing There of obesity and The dramatic rise in the prevalence Type 2diabetesisariskfactorforvasculardama- Type 2diabetesandaBMIof35kg/m inpeoplewith surgical procedures.Nationalguidelinesforbariatricsurgery patient education,followupandclinicalaudit,aswellsafeeffective care, for theprocedureandcomprehensiveongoingmultidisciplinary international andnationalguidelines.Thisrequiresappropriateassessment forTypeBariatric surgery 2diabetesmustbeperformedwithinaccepted Type 2diabetesiscost-effective. Available forobesepatientswith evidenceindicatesthatbariatricsurgery modality forType 2diabetes,furtherresearchisrequired. asatherapeutic In ordertooptimizethefutureuseofbariatricsurgery short- andlong-termoutcomes. be establishedinordertoensurequalitypatientcareandmonitorboth should ofpersonswhohaveundergonebariatricsurgery A nationalregistry of healthbenefits,includingareductioninall-causemortality. inseverelyobesepatientswithTypeBariatric surgery 2diabeteshasarange or gallstonesurgery. and similartothatofwell-acceptedproceduressuchaselectivegallbladder isgenerallylow The morbidityandmortalityassociatedwithbariatricsurgery promulgated. st century. Arq Bras Metab. Endocrinol 2011;55/6 2 ormoreneedtobedevelopedand Arq Bras Metab. Endocrinol 2011;55/6 calculated asbody weightinkilogramsdivided bythe Obesity isusuallyclassified by bodymassindex(BMI), How isobesitydefined? theycanberecommended. before validation further requires benefits. Theuseofthese loss and others additional non- metabolic development phase.Somefocusprimarilyonweight in the and devices that are testinal surgical procedures - range ofnovelextraluminalandendoluminalgastroin isalargeged thatthisisanemerging fieldand there Itisacknowled- blished bariatricsurgical procedures. to identifyprioritiesforclinicalresearch. whenindicated;and equitableaccesstosurgery ensure forhealthpolicychangesthat and suggestinterventions accesstosurgery prevent thatcurrently identify barriers for clinicians;to to developpracticalrecommendations Type 2diabetes.Thespecificgoalsofthepanelwere: ofobesityand andprevention tions inthetreatment - interven andothergastrointestinal of bariatricsurgery role inDecember2010todiscusstheappropriate perts gists, endocrinologists,surgeons andpublichealthex- ofdiabetolo- tion convenedaconsensusworkinggroup diabetescontrol. prove to im- of patients who seek surgery care and long-term perioperativemanagement procedure, of interventional evaluation,choice guidanceinthepreoperative expert aneedexistsforworldwide worldwide use.Therefore, for ofcare thisrapidlydevelopingarea ly considered - sity anddiabetes(10-15),theIDFhasnotprevious inpatientswithobe- the utilizationofbariatricsurgery consensus statementshavingbeenpublishedregarding (9). mortality in diabetes-related reduction (5) and specific of overall survival provement havedocumentedanim- apnoea (8)andseveralreports dyslipidaemiaandsleep , tantially improve hasbeenshowntosubs- In addition,bariatricsurgery obeseindividuals (7). tolerance to diabetes in severely glucose impaired from progression prevent effectively ofType 2diabetesandcan se dramaticimprovement morbidobesityalsocau- originally designedtotreat (5,6). substantialweightloss toproduce surgical procedures – that is, bariatric surgery benefit substantially from ofdiabetesanditsassociatedriskfactors,can control This consensusstatementconsidersprimarilyesta- The IDFTaskforce- onEpidemiologyandPreven and Despite anumberofevidence-basedreviews (GI)operationsthatwere Several gastrointestinal at-risk ethnicities. investigationshouldexamineother tions andfurther diseaseinAsianpopula- of diabetesandcardiovascular risk the increased tion havebeensuggestedtoaddress (Table 1).Additionalcut-pointsforpublichealthac- co-morbidity,obesity-related includingType 2diabetes to beclassIIIobesityorIIwithsignificant sizecategories. rent - chers andpolicymakerstoallocateindividualsdiffe usedbyresear acceptedstandard is theinternationally BMI intheabsenceofabetteralternative, at present, thehealthrisksofexcessweight.Nevertheless, affect tion offat:boththeseaspectsbodycompositioncan tion ofbodyweightthatconsistsfatorthedistribu- thepropor addition, BMIdoesnotnecessarilyreflect healthrisksinotherpopulations.In underestimate ethnicity,populations ofmainlyEuropean andoften obesity, whenBMIexceeds30kg/m particularly evidence suggestscontinueduseofBMIasanindex theclearest fat mass,havealsobeenused,butcurrently andcentralperipheral cluding waistcircumference listedinTableconsequences, are 1.Othermethods,in- (WHO), basedonassociationswithadversehealth BMI, asdefinedbythe World HealthOrganization height in metres squared (kg/m squared height inmetres sidered the primary riskfactor (16).Ithasbeenesti - theprimary sidered its causeshaveyettobefully explained,obesityiscon- and,while disorder Type 2diabetesisaheterogeneous The linkbetweenobesityand T * T Source: AdaptedfromtheWorld HealthOrganization(WHO)2004[75]. We withinthecolouredzonesabove. addresseligibilityandprioritizationforbariatricsurgery aresetat23,27.5,32.5and37.5kg⁄m that publichealthactionpointsforinterventions able 1. byBMI Theclassificationofweightcategory Obese classIII Obese classII Obese classI Pre-obese Normal range Classification For Clinically severe or ‘morbid’ obesity is considered or‘morbid’obesityis considered Clinically severe BMI categorieshavebeendevelopedprimarilyin Asian populations, classifications Principal cut-off remain 35.0–39.9 30.0–34.9 25.0–29.9 18.5–24.9 IDF positionstatement-bariatric surgery points ≥ 40.0 the same ype 2diabetes BMI (kg⁄m as 2 the ). Classificationsof international Cut-off pointsfor 2 ) 37.5–39.9 35.0–37.4 32.5–34.9 30.0–32.4 27.5–29.9 25.0–27.4 23.0–24.9 18.5–22.9 Asians* ≥ 40.0 classification, 2 . 2 [74]. 369 but - -

Copyright© ABE&M todos os direitos reservados. Copyright© ABE&M todos os direitos reservados. 370 system. althcare but discriminationatwork, sociallyandwithinthehe- condition,and physical consequences of their chronic not only with the health obesity often struggle severe by Peopleaffected andtreatment. to bothprevention approach acomprehensive for health,whichrequires withseriousadverseconsequences disorder chronic noted earlier, obesityis acomplex,multifactorialand obesityandType 2diabetes(27,28).Aswith severe forpeople healthcare andcosteffective, cally effective, ofclini- to theprovision titudes havebeenabarrier maintenance ofweightlossdifficult. physiological mechanisms(25,26),makinglong-term evidence thatbodyweightisdefendedbypowerful for individuals.Additionally, theemerging itignores other lifestyle factors mitigate against weight control behaviourand sedentary increasing in foodpreparation, anabundantfoodsupply,ment’) (24),where changes - societies(the‘obesogenicenviron ofmodern effects obesity-promoting It alsofailstoconsiderthepervasive compounded byphysical,emotionalandsocietalissues. obesity(23) genetic anddevelopmentalbasestosevere orlackofmotivation. failure ofpersonal andaresult asa‘cosmetic’problem trued obesityistoooftenmiscons- weight. Severe current fortheir responsible majority ofobeseindividualsare widelyheldcommunityattitudesthatthe are There Negative attitudestowardobesity withdrawals associatedwithadverseevents. forweightlosswithrecent few medicationsapproved now are obese (5,21,22). There larly intheseverely - sustained,particu obese, peopleismodestandrarely severely and medicalmethodsbyobese,particularly that significantweightlossachievedbyusinglifestyle dyslipidaemia (20).However, evidence isstrong there and and associatedconditionssuchashypertension inglycaemiccontrol is associatedwithimprovements orobese ple withType 2diabeteswhoare (19). not overweight origin,are 15%inpopulationsofEuropean proximately ofpeoplewithType 2diabetes,ap- A smallproportion obeseratherthanofhealthyweight(17,18). severely 93-foldinwomenand42-foldmenwhoare creased mated thattheriskofdevelopingType 2diabetesisin- IDF positionstatement-bariatric surgery In the context of treatment, negativesocietalat- In thecontextoftreatment, strong However, thevery thisperspectiveignores evenmodestweightlossinpeo- term, In theshort

monotherapy, but≥ HbA thatan tes (EASD)consensusstatementrecommends AssociationfortheStudyofDiabe- and European over time.TheAmericanDiabetesAssociation(ADA) doses of therapiesbyaddingnewagentsinincreasing the needforcontinuousmonitoringandintensification inweightgain. themselves canresult Type 2diabetes,includinginsulin, used fortreating not achievingtargets. Anumberofthesemedications obese, with many of thesepatients amongst theseverely bloodglucoselevels limitedsuccessincontrolling very for, lifestylechange.Unfortunately, suchstrategieshave all ideally added to, and not exchanged are cose control regimens. ded asanessentialcomponentofdiabetestreatment physicalactivityshould beinclu- ght lossandincrease wei- topromote diabetes (16).Lifestyleinterventions Type 2 means ofcontrolling logical andcost-effective ght loss,withitsmanybenefits,shouldbethemost thatwei- provide diabetes, guidelinesonitstreatment oversubsequentyears(31,32). lar diseaseandmortality - risk of macrovascu continueto deliver reduced control disease.Yearsof microvascular glycaemic ofimproved –andnotjustforprevention important isvery control dyslipidaemia, smoking and inactivity) but glycaemic riskfactors(hypertension, ment ofallcardiovascular for Type 2diabetes mustalsoincludeactivemanage- therapeutic challenge. Treatmentsion isaformidable - thisprogres (30).Arresting therapy andpolypharmacy capacity overtimeandtheneedforintensificationof lossofinsulinsecretory isofprogressive natural history totherapy. tosuboptimalresponses resulting phenotypesoften therapiesavailabletodifferent rent - to match thediffe difficult the sameanditiscurrently thatnotallType 2diabetesis torecognize important people.Itisvery extentsindifferent but todifferent inthepathogenesisofType 2diabetes (29), important are reserve and insulin secretory Both Why considerbariatricsurgery? used HbA glycaemic therapiesintheearly stagesofdiabetes.NICE intensificationof vigorous more (NICE) (12),support National InstituteforHealth andClinicalExcellence theUK’s Some nationalguidelines,such asthosefrom A major problem formanagingType 2diabetesis A majorproblem Medical therapeuticoptionstargeting primarilyglu- ofobesityintheaetiology ofType 2 Given therole diseaseandtheusual Type 2diabetes isaprogressive 1c of 7% (53 mmol/mol) is a call to action (33). of7%(53mmol/mol)isacalltoaction(33). 1c ≥ mol/mol) to increase from from 6.5%(48mmol/mol)toincrease 7% (53 mmol/mol) for increasing 7%(53mmol/mol) forincreasing Arq Bras Metab. Endocrinol 2011;55/6 dered in appropriately selectedindividuals. inappropriately dered needstobeconsi- the optionofbariatricintervention isstillelusive.Given thisscenario, metabolic control ofmaximizing nagement forType 2diabetesinterms with diabetesisasignthattheanswerastobestma- engagement inself-care. toencouragelifelong psychologicalsupport ly provide - routine aspects oftheirlives.Very fewclinicalservices patientengagementinmany issuesaround remain re deployment ofexistingmedicaldiabetestherapies,the- of this (31). evidence to demonstrate the efficacy current islimited atdiagnosis(36,37),butthere polypharmacy fied early. haveevenbeensuggestionsofstarting There andintensi- started are –iftreatments of progression –orevenpossibly slowedrate complication prevention toachievetargets (35). clinicians upforfailure set fying lifestyleorothertime-consumingmeasures andonintensi- onlossofglycaemiccontrol that rely approaches escalatetherapies.Current professionals re isconsiderable(34). early intervention of asthelegacyeffect lessvigorously should betreated not betakentomeanpeoplewithearlyType 2diabetes wasintensified(31).Thisshould vement astreatment Arq Bras Metab. Endocrinol 2011;55/6 on body weight alone (39), thena- tely by their effects de metabolicchangesthatcannot beexplainedcomple- - provi evidence that some bariatric procedures growing qualityoflife (38). sleep apnoeaandimproved tructive obs- hyperglycaemia. hyperlipidaemia,blood pressure, of ornormalization benefits, includingimprovement canbeassociatedwithsubstantial otherhealth surgery loss isonlyoneoftheoutcomessuchsurgery. Bariatric ving substantial sustained weight loss. In reality, weight achie- originallyevolved around goals ofbariatricsurgery substantialweightloss.Accordingly,signed toproduce de- forweight,definessurgical procedures baros word ‘bariatric’ surgery, The term the Greek derived from Evolving concept:bariatric-metabolicsurgery management targeting HbA intensive disease to very tes and existing cardiovascular In important. to tripletherapiesandbeyond.Thisisvery inthosepeople who failedtoshowHbA driven by was higher in the intensive group, mortality one trialthatrandomizedpeoplewithType 2diabe- The continuing morbidity and mortality in persons The continuing morbidity and mortality andsuboptimal profiles theside-effect from Apart of interms It maybepossibletoachievemuchmore A criticalissuehasbeentherateatwhichhealthca- In view of the broad benefitsofweightlossandthe In viewofthebroad 1c < 6.5% (48 mmol/mol), <6.5%(48mmol/mol), 1c - impro ce outcomes. willinfluen- care mework ofongoingmultidisciplinary withinafra- modifying theirdietandlevels ofexercise In addition, eachpatient’scommitmentto cedure. - andthechoiceofbariatricpro therapy requirements, hypoglycaemic duration ofdiabetes,thepre-surgery regain, fluenced bytheextentofweightloss, ble 2). at2and 10 yearsfollow-up(Tawell-matched controls - with when compared electing to have bariatric surgery obesepatients of2037(7)severely diabetes inagroup ofType 2 andsustainedremission trated theprevention described. poorly mical outcomes,andfollow-upofmostcohorts appropriate name. appropriate is emerging as a more me ‘bariatric-metabolic surgery’ sed on clinical reporting, notHbA sed onclinicalreporting, waslargely ba- asremission limitations tothisreview than2yearsaftersurgery.more significant were There inremission with diabetesatbaseline,62%remained sion’ ofdiabetesfollowingsurgery. Amongpatients - of diabetes (6). Overall,78.1% ofpatients had ‘remis manifestations sion oftheclinicaland/orlaboratory remis- onthe reporting patients identified103studies 135,000 of 621studieswhichincludedapproximately qualityoflife(38). inhealth-related improvements and -morbidities suchasType 2diabetes,hypertension obesity,severe inco- accompaniedbyimprovements atment inobeseclassI(BMI>30kg/m - weightlossthanconventionaltre ingreater resulted and withoutdiabetesconcludedthatbariatricsurgery significant weightlossisevident(41,42). ved withindaysofgastricbypasssurgery, any before can be achie- in glycaemic control ned improvements addition toweightloss.Forexample,rapidandsustai- (40),in neural changesaftersomesurgical procedures or andpossiblyotherhormonal ofincretins effects to beindependentmetabolicbenefits,associatedwith alsoappear There cal changesthatdriveweightregain. food intake and modifying the physiologi- by reducing alteringenergy balance,primarily weight lossthrough weightandmaintain aimtoreduce Bariatric procedures Baria The extent of remission ofType 2diabetesisin- The extentofremission The SwedishObeseSubjectsstudyclearlydemons- A less rigorous systematic review andmeta-analysis systematicreview A lessrigorous A 2009 Cochrane review includingpatients with A 2009Cochranereview tric surgery andType2dibets IDF positionstatement-bariatric surgery 1c orotherbioche- 2 ) aswell 371

Copyright© ABE&M todos os direitos reservados. Copyright© ABE&M todos os direitos reservados. mon in those who had received surgery (73vs.13%). surgery mon inthosewhohadreceived com- ofdiabeteswassignificantly more years, remission After2 with afocusonweightlossbydietandexercise. to conventional diabetes therapy nagement programme ma- of a comprehensive justable gastric banding as part ad- laparoscopic for Type 2diabetes (43).Itcompared specificallyasatreatment investigated bariatricsurgery trial(RCT)whichhas randomizedcontrol prospective 372 matched controls. with for diabetes and 60% forcancer when compared disease,92% artery 56%forcoronary were rated group reductions intheope- Specificmortality surgical group. of40%inthe reduction all-causemortality long-term anadjusted (Utah, USA)(9).Theanalysisreported subjectswhohadappliedfordriver’slicences control withage-,sex-andBMI-matched mortality long-term for compared were undergone gastricbypasssurgery studyofalmost8,000patientswhohad pective cohort - subjects(9,47).Alarge retros nity matchedcontrol withcommu- advantagewhencompared this mortality dence inwomen(46).Otherstudieshaveconfirmed reduction incancerinci- alsoledtoaspecific surgery (5).Bariatric obesegroup risk factorsinthisseverely afteraccountingforsex,ageand in all-causemortality wasassociatedwitha29%reduction bariatric surgery Subjects Studyafteranaverageof11yearsfoundthat for morbidlyobeseindividuals(45). deathwas quadrupled found theriskofdiabetes-related Studies Collaboration milar analysisbytheProspective BMI (44) (Table ratios with increasing hazard 3). A si- riseinthemortality tralia showaconsistentprogressive andAus- America,Europe North studies largely from inprospective than1.4millionparticipants of more inadditiontoType 2diabetes.Areview alth problems obesityisassociatedwithalarge numberofhe- Severe benefitsbeyonddiabetes? Bariatric surgery * the SwedishObeseSubjectsStudy[7] T IDF positionstatement-bariatric surgery able 2. Two- Remission 10-year remission 2-year remission 10-year incident 2-year incident Remarkably, isonly a sole acceptably designed there Follow-up of participants intheSwedishObese Follow-up ofparticipants based on and fasting 10-year plasma diabetes glucose Surgical < 36% 72% 8% 1% 7.0 incidence mmol ⁄ l and and not on remission* hypoglycaemic Control 13% 21% 24% 8% rates therapy from [7]. life instruments (48,49). life instruments usingbothgenericandobesity-specificquality-of- gery quality of life following bariatric sur in health-related Many studies havedemonstrated major improvements sleepapnoea. orobstructive debilitating weight loss on other aspects of their health; for example, Type 2diabetes wouldalsoexperiencethebenefitsof primarilyfor asatreatment who havebariatricsurgery wever, by lifeexpectancymightindeedbeimproved complications maynotbeavailable.Ho- crovascular and mi- for macro- high cost interventions tries where not beenconductedinlow- andmiddle-incomecoun- criteria. compelling evidenceforfundingbasedoneconomic themost outcomeandprovides Thisisarare cohort. cost savingsandhealthbenefitsoverthelifetimeof generatesboth indicatesthatanintervention result The‘dominant’ thresholds. -specific cost-effectiveness - tocountry achieved atanacceptablepricerelative indicatesthathealthbenefitsare of ‘cost-effectiveness’ py. Thefinding Studyanalyseshavebeenconservative. thera- therapy forTypeto standard 2 diabetes relative ordominantasa cost-effective tobeeithervery gery diabetes (Table studiesfoundbariatricsur 4).Allthree forpatientsspecificallywith analyses ofbariatricsurgery cost savingordominant(52). (51) and,insomeanalyses, assessed ascost-effective obesity,severe of diabetes status, hasbeen regardless for within10yearsofdiagnosis.Bariatric surgery red .Over60%ofthemedical cost wasincur mature - atwork,disabilityandpre productivity sence, reduced costscaused byworkab- its complicationsandindirect medicalcostsof diabetes and included boththedirect if diagnosedattheageof30years(50).Theestimate person diagnosed at the age of 50 years and $US 305,000 a for the lifetimecosthasbeenestimatedat$US172,000 substantial.IntheUSA, The costsofType 2diabetesare cost-effective? Is bariatricsurgery T able 3. Mortalityhazardratiosforwhitenon-smokers[44] White men White women It would be expected that morbidlyobese patients It is recognized that cost-effectiveness studies have studieshave thatcost-effectiveness It isrecognized cost-effective identifiedthree review A literature 22.5–25 kg ⁄m 1.0 1.0 2 kg ⁄m 30–35 Arq Bras Metab. Endocrinol 2011;55/6 1.44 1.44 2 kg ⁄m 35–40 2.06 1.88 2 kg ⁄m 40–45 2.93 2.51 2 - - - Arq Bras Metab. Endocrinol 2011;55/6 adjus- laparoscopic Roux-en-Y gastric bypass(RYGB), – surgery endorsed thatconventional gastrointestinal management ofType 2diabetes.Delegates strongly forthe surgery examinedgastrointestinal tional experts solelyforhistoricpurposes(53). and provided isdated that their information NIHwebsitewarns rent 1991.Thecur StatementMarch lopment Conference National InstitutesofHealth(NIH)ConsensusDeve- recommendations ofthe theexpert guidelines reflect summarizedinTableThey are 5.Mostoftheexisting ofType 2diabetesinparticular.and forthetreatment obesityingeneral, ofsevere forthetreatment surgery A numberofguidelinesexistontheusebariatric What eligibilityguidelinesexist? ning, whichcanbecostsavinginlow-incomecountries. - scree educationand retinal tiatives, suchasfootcare, ini- prevention essential medicinesandothersecondary of whenweighedagainst the provision cally appropriate iseconomi- services withitssupport bariatric surgery whether sed. Itisuptoeachhealthsystemdetermine - inthesesettingsandmorbiditydecrea bariatric surgery In mid2006:1Euro=$A1.72⁄£0.69$US1.28. CE, cost-effective;QALY, quality-adjustedlife-years. * Basecase. T able 4. Cost-effectivenessofbariatricproceduresinpeoplewithdiabetes Study 2006, lifetime Keating andcols.[76],Australia,$A $US 2005,lifetime Hoerger andcols.[77],USA, £ 2006,20years Picot andcols.[51],UK, Standard care* Standard care* Banding surgery Bypass surgery Banding surgery Bypass surgery Standard care* Banding surgery Standard care* Banding surgery - Summitof50interna Diabetes Surgery A recent Recently diagnosed Recently diagnosed Recently diagnosed Recently diagnosed Recently diagnosed Recentlydiagnosed T ype 2diabetes Established Established Established Established status T otal costs 101,376 71,130 98,931 86,655 89,029 99,944 79,618 96,921 31,683 33,182 - BMI >35kg/m Type 2diabetesinacceptablesurgical candidateswith of forthe treatment (BPD) –shouldbeconsidered diversion table gastricband(LAGB)orbilio-pancreatic ciety ofAustralia andNewZealand(54).The statement So- physicians and surgeons and the Obesity Surgery Australian andNewZealand Collegesforpaediatric recommendations. thathavesimilar of guidelinesandconsensusreports developmental andphysicalmaturity. arange are There suitableforadolescentsof isonlyconsidered surgery demonstrates aneedforadditionaltherapy. Bariatric andadolescents obesityinchildren valence ofsevere However,diatric obesitytreatment. - pre thegrowing -quality medicalmanagement,isthemainstayofpae- whole-of-familylifestylechange,withhigh- Long-term Recommendations foradolescents -moderate obesity(BMI30.35kg/m withmild-to- diabetes incandidatessuitableforsurgery Type 2 forinadequatelycontrolled deemed necessary lifestyle andmedicaltherapy. trialevidencewas Further QAL 11.76 11.12 9.55 14.5 15.7 9.38 7.68 9.02 10.39 11.49 Ys A recent position statementwasdevelopedbythe A recent ratio (ICER), Costper cost-effectiveness Generate 1.2QALYs Incremental Save $2444 (ICER N⁄A) 11,000 12,000 13,000 QAL 7,000 1,367 — — — 2 who are inadequately controlled by inadequatelycontrolled whoare Y IDF positionstatement-bariatric surgery Cost-effectiveness threshold⁄ interpretation £20–30 000 $US 50,000 2 Dominant $A50 000 ) (14). Very CE Very CE Very CE Very CE Very CE — — — 373

Copyright© ABE&M todos os direitos reservados. Copyright© ABE&M todos os direitos reservados. 374 ad- suchas laparoscopic procedures non-diversionary metabolic changes,atleast initially, thanless invasive, profound weight loss and more nerally leadtogreater tensive surgery, suchasRoux-en-Y gastric bypass, ge- ex- in achievingweightloss.Those thatinvolvemore effective are A numberofbariatricsurgical procedures ineffectiveness? Do proceduresvary had BMI>40kg/m ifadolescents be considered surgery recommended * T IDF positionstatement-bariatric surgery for adolescents. conventionalbariatricsurgical procedures currently are adjustable gastric banding(LAGB), and laparoscopic namelyRoux-en-Y gastricbypass(RYGB) procedures, cations (10,55). and US publi - and BMI, have been listed in European eligibility criteria,withsomevariationinyoungestage psychosocial needsofadolescentpatients.Very similar follow-upofthemetabolicand sment andlong-term withteams experiencedintheasses- in unitsaffiliated shouldbeprovided therapy andfollow-up.Surgery inpost-surgical and understandtheneedtoparticipate months, andtheytheirfamilymustbemotivated for6 oflifestyle±pharmacotherapy programme nary Potential candidatesshouldhavefailedamultidiscipli- skeletal maturity, consent. informed andcouldprovide withTanneryears ormore, stage4or5and pubertal aged 15 -morbidities (includingType 2diabetes),were ADA, long-term follow-up;andindividualrisk–benefitrationeedstobeevaluated. for HealthandClinicalExcellence;NIH,NationalInstitutesofHealth;SIGN,ScottishIntercollegiateGuidelines Network. able 5. (adults) Nationalandinternationalguidelines*foreligibilitybariatricsurgery Review Comment Eligible (B):BMI Eligible (A):BMI Year Recommended: BMI The American This IDFpositionstatementadvisesthatonlytwo guidelines Diabetes above are Association; qualified by 2 NCD, , or>35kg/m Outdated ofhistoric the with oneserious NIH [78](USA) Medicare NCD 2004 removed 30–35 kg⁄m 35–40 kg⁄m ‘serious’ BMI co-morbidity weight-loss- > 40kg⁄m responsive non-communicable following interest 1991 common 2

2 2

elements: disease; 2 Review in3years with severe co- withsevere with oneserious < BMI35kg⁄m Recognized use NHMRC [59] 35–40 kg⁄m co-morbidity weight-loss- (Australia) responsive > 40kg⁄m suggested A, appropriate 2003 eligible 2 BMI; 2

2 non-surgical B, eligible could improvewith with diseasethat NICE [12](UK) 35–40 kg⁄m weight loss >40kg⁄m > 50kg⁄m weight-loss conditional 2006 remission were usuallynot reported. were remission of remission, andbiochemicalmeasures definition of wasnoconsistent follow-upvaried, there where rature however, waslimitedby thequalityofavailablelite- rates(Tablelead tohigherremission 6).Thisreview, excess weight loss greater producing The procedures ves inthemajorityofpatientsafterbariatricsurgery. - orimpro thatdiabetesremits and cols.(6)reported tes inobesepatients(56). forType 2 pectomy (liposuction)asadiabe- treatment subcutaneousli- is absolutelynoevidencetosupport weight loss may be the key benefit. There longer term, derlying mechanismsdrivingType 2diabetes.Inthe on the un- durableorhaveafundamentaleffect ges are ofType 2diabetes.Itisnotclearifthesechan - control inglycaemic improvement an earlynon-weightrelated milieuandprovide influencetheguthormonal cedures - justable gastricbanding.Roux-en-Ybypasspro † * Systematicreview(Buchwaldetal.[6]). T remit at2yearsafterconventionalbariatricprocedures* Mean %onBMIinexcess of25%thatislost. able 6. Laparoscopic adjustablegastricband Roux-en-Y gastricbypass Bilio-pancreatic diversion A systematic review of the literature byBuchwald oftheliterature A systematicreview 2 2

2

BMI; measures Estimated NHMRC, does pre-surgery European [10] have 35–40 kg⁄m co-morbidity weight-loss- Weight loss not change responsive > 40kg⁄m eligibility with one National 2007 been weight tried Health 2

loss 2

and and failed; and if and co-morbidityis insufficient vidence Medical Arq Bras Metab. Endocrinol 2011;55/6 AD control BMI <35kg⁄m percentage 35–40 kg⁄m there A [63](USA) > 40kg⁄m difficult to date 2010 is Research % excess BMI loss of the diabetes 49 63 73 provision 2 of 2

Council; 2

those † for, > 35kg⁄m NICE, with loss-responsive serious weight- and co-morbidity (Scotland) % remission SIGN [79] of diabetes a National diabetes 2010 commitment 2 57 80 95 withone Institute who to, ding (see Recommendations for adolescents above). ding (seeRecommendationsforadolescentsabove). adjustable gastric ban- -Y gastric bypassand laparoscopic inadolescents.Roux-en- acceptedprocedures considered were and theduodenalswitchvariant.Two procedures diversion withbilio-pancreatic and metabolicconcerns ding sleevegastrectomy, safety, are andthere nutritional dataregar waslimitedmedium-orlong-term that there (57).However, cepted procedures itwasacknowledged ac- (SG) as currently (BPD-SD), andsleevegastrectomy diversion(BPD)andtheduodenal switchvariant creatic adjustablegastricbanding, bilio-pan- bypass, laparoscopic ordevices. procedures anddonotapplytonewexperimental gical procedures acceptedbariatricsur this consensusapplytocurrently Recommendationsmadeby ch patientstoprocedures. datathatcanbeusedtomat­ fewhard are to date,there intheirrisksand benefits and, vary surgical procedures team. with theirbariatricsurgical multidisciplinary obese patientsinconsultation must bemadeby severely Thedecision practiceandexpertise. riation inregional risk-benefitanalysisandacceptanceofva- ring a careful Arq Bras Metab. Endocrinol 2011;55/6 includeanastomotic andstaple-line leaks(3.1%), gery riskforbariatricsurgery.associated withincreased of Type 2diabetes hasnotbeenfoundtobe presence shown in Table risk are sociated withincreased 7. The andpatientfactorsfoundto be as- (59). Programme cholecystectomy (58) and described as ‘low’ paroscopic is estimatedat0.1%-0.3%,aratesimilartothatforla- associatedwithbariatricsurgery The 30-daymortality What aretherisksofbariatricsurgery? procedure inpatientswithT T • • • • • • ext box3Factors toconsiderwhenchoosinga The consensus group consider that Roux-en-Y gastric considerthatRoux-en-Y gastric The consensusgroup that all conventional to recognize It is important - iscomplex,requi The choiceofbariatricprocedure The mostcommoncomplications ofbariatricsur to adhereit The follow-upregimenfortheprocedureandcommitmentofpatient function The durationofType 2diabetesandthedegreeofapparentresidualB-cell The simplicityandreversibilityofaprocedure perioperative morbidityandmortality The patient’s generalhealthandriskfactorsassociatedwithhigh fully described of compliance,andtheeffectsoneatingchoicesbehaviourshavebeen The patient’s preferencewhentherangeofrisksandbenefits,importance Expertise andexperienceinthebariatricsurgicalprocedures ype 2diabetesinclude: - - - ments havebeenattributed to higherhospitalvolumes, - 0.89to0.19%. Improve from overall earlymortality in forthe period1998-2004,withareduction surgery inbariatric aninefoldincrease ch andQualityreported Resear diversion (58).TheUSAgencyforHealthcare Roux-en-Y gastricbypassand1.1forbiliopancreatic adjustablegastricband,0.5%for 0.1% forlaparoscopic with followsasimilartrend, post-surgical mortality (62).Thirty-day diversion,respectively bilio-pancreatic band, sleeve gastrectomy, Roux-en-Y gastric bypass and adjustable gastric and 25.7% following laparoscopic complicationat1-yearratesof4.6,10.8,14.9 or more one andreported over 57,000consecutiveprocedures Outcomes LongitudinalDatabase(BOLD)reviewed lated tothecomplexityofsurgery. TheUSBariatric andnoneincreased. attacksandstrokes) art ,he- andpulmonary deep-venous thrombosis woundre-opening, (ulcers, dumping,haemorrhage, unchanged by 29.50%. Other complications remained andpneumoniadiminished failure leakage, respiratory staple other complicationssuchasabdominalhernias, by58%,while Postsurgical infectionratesdropped of olderandsickeroperative patients. the percentage in ∼24to15%,despiteincreases cation ratesfellfrom 652 hospitalsin2001-2002vs.2005-2006.Compli- at obesitysurgery > 9,500patientswhounderwent complications among 2006 (61).Thisworkcompared between 2002 and plications after bariatric surgery a21%declineincom- andQualityreported Research ofbariatricoperations(60). proportion creasing whichconstituteasteadilyin- procedures, laparoscopic lower after (1.7%). Morbidity rates are haemorrhage events(2.2%)and wound (2.3%),pulmonary T able 7. Patientandprogrammefactorsassociatedwithriskofsurgery Morbidity andmortalityincreasewith Surgeon inexperienceorinlearning Open comparedwithlaparoscopic fortheparticularprocedure curve Programme–surgical factors occasionally performing surgery the complexityofprocedure - re are Early post-operativemorbidityandmortality A newstudybytheUSAgencyforHealthcare Low volumecentreorsurgeon Revisional surgery ‘higher risk’ procedures IDF positionstatement-bariatric surgery Patients’ factors ‘higher risk’ Limited physicalmobility Obstructive sleepapnoea High riskofpulmonary thromboembolism Increasing BMI Hypertension Male gender Older age [80,81] 375 -

Copyright© ABE&M todos os direitos reservados. Copyright© ABE&M todos os direitos reservados. ++, sufficient. +++, appropriate especiallyinhigher-risk groups. 376 +, T complications (59). ting forbothperi-operativeriskandpossiblelong-term fit ratio assessed individually for each patient,accoun- andtherisk-bene- important Realistic expectationsare bidity orco-morbidity, qualityoflifeandproductivity. inmortality,in thelightofpotentialreductions mor forallprocedures. required supplementation are advice,evaluationand in Table dietary 8.Long-term isshown ofnutritionalriskwitheachprocedure mary issues(11).Asum- these important address Surgery and theAmericanSocietyforMetabolicBariatric tion ofClinicalEndocrinologists,TheObesitySociety Clinical guidelinesdevelopedbytheAmericanAssocia- (11,63). insulinhypersecretion hypoglycaemia from and,rarely,rosis Wernicke’s encephalopathyandsevere sion, includevitaminandmineraldeficiencies,osteopo- diver Roux-en-Y gastric bypass and bilio-pancreatic be suspected.Longer-term especiallywith concerns, shouldacomplication forsurgical referral threshold post-bariatric surgical patientsshouldhavealow Allthosemanaging important. complications isvery usuallyspecifictothesurgical intervention. blems are - notuncommonandexpectedpro are surgical revisions (61). ding procedures inban- andanincrease surgery a movetolaparoscopic IDF positionstatement-bariatric surgery deficiency. BPD, requirements maybenecessary. procedure gastrectomy. LAGB, able 8. acids essential fatty vitamins and Fat-soluble Protein Vitamin D Calcium Folate Vitamin B12 Thiamine Iron recommended significant high The risks of each procedure need to be considered needtobeconsidered The risksofeachprocedure managementof Early detectionandappropriate Longer-term surgical complicationsandneedfor bilio-pancreatic laparoscopic risk Careful A risk of summary daily deficiency. monitoring of adjustable diversion; intake deficiency LAGB of ++ + (allowance) Additional + + + + + + is gastric BPD-DS, more recommended. or increased band; common specific or SG bilio-pancreatic ++ ++ ++ ++ ++ + + + standard RYGB, requirements. Supplementation supplementation Roux-en-Y nutritional RYGB multivitamin +++ +++ ++ ++ ++ + + + diversion Specific gastric is well preparation concerns BPD +++ +++ +++ +++ with ++ ++ ++ necessary + bypass; supplementation in duodenal excess BPD-DS likely SG, for to +++ +++ +++ ++ ++ ++ ++ of + prevent switch; sleeve each to daily be is - - tions needing a chronic-disease approach tocare. approach tions needingachronic-disease condi- chronic obesityandType 2diabetesare Severe tofunctionappropriately.these mustbewellresourced andacknowledgethat the expansionofnationalregistries longitudinalstudies. Wetinuing long-term encourage andcon- registries is arangeofnationalbariatricsurgery of bariatric surgery. effects and long-term There efficacy T clinicalguidelines(2007) (10). (11) andEuropean guidelines(2008) ty forMetabolicandBariatricSurgery nologists, TheObesitySocietyandtheAmericanSocie- the combined American Association of Clinical Endocri- Institute for Health and Clinical Excellence (2006) (12), forobesity,bariatric procedures includingtheUKNational guidelinesfortheuseof isarangeofcomprehensive There Components ofsuccessfulbariatricsurgery include: diabetes andcomponentsofsuccessfulprogrammes • • • • • • • • • • • • ext box4ConsiderationswithrespecttoT Continuing efforts are required tomonitorthesafety, required are Continuing efforts ‘centres ofexcellence’or equivalentandcollectprospectivedatathrough registries All practicesareencouragedtoengageandprom ote nationalprogrammesof committed toincreasedlevelsofongoing daily physicalactivity In ordertohelpsustainweightlossfrombariatric surgery, patientsmustbe and severeobesity appropriate. Mentalillness,especiallydepression, iscommonindiabetes Follow-up shouldincludeapsychological evaluation,supportandtherapyif weight lossandmaintenance nutritional supplementation,supportandguidancetoachievelong-term appropriate ,monitoringofmicronutrientstatusandindividualized Regular, post-operativenutritionalmonitoringisrequired,withattentionto methods consistentwithIDFrecommendations Teams shouldcollectprospectivedataandmeasurediabetesoutcomesin support, andpost-surgicaldiabetesmonitoring Lifelong follow-uponatleastanannualbasisisneededforongoinglifestyle the surgeonorothersforspecificcare long-term complicationsinatimelymannerandknowwhentoreferback teamneedtounderstandandrecognize earlyand The multidisciplinary visibility atthetimeofsurgery short-term pre-operativeweightlossconsideredtoimprovehealthand Management ofdiabetesandotherco-morbiditiesshouldbeoptimized nutritionalsupportandfollow-up their lifelongroleinlifestyleintervention, alongwith have realisticexpectationsoftherisksandbenefitssurgery of metabolic,physical,psychologicalandnutritionalhealth.Patientsshould Pre-surgical assessmentneedstobecomprehensive,including programme performedwithinthe specialist experienceintypesofbariatricsurgery trainingandhave The surgicalteammusthaveundertakenrelevantsupervized agreed policies and lifestylesupport,surgeon’s teamswithconsistentmessagesand care,diabetesmanagement,nutritional team needstointegratewithprimary disciplines andworktogetherwithcommonexpectationsgoals.The and diabetes.Membersoftheteamshouldhaveunderstandingacross teamsthatareexperiencedinthemanagementofobesity multidisciplinary shouldbeperformedinhigh-volumecentreswith Bariatric surgery management ofType 2diabetesandobesity isacomponentoftheongoingprocesschronicdisease Bariatric surgery

Arq Bras Metab. Endocrinol 2011;55/6 ype 2 ype 2

therapies. Forexample,bloodpressure,dyslipidaemiaandobstructivesleepapnoea. is non-surgical weight-losstherapy*,BMI,ethnicity tcomes. These shouldbeassessedbythesurgical team. ase the risk of surgery, later complications or poor ou- - and specific conditions that substantially incre surgery general conditionsthatwould contraindicateelective are (11).Inaddition,there withbariatric surgery quired - andlifestylechangesre expected outcomes,alternatives oftherisks-benefits, ness; andlackofcomprehension psychiatricill- oralcoholabuse; uncontrolled drug rent Arq Bras Metab. Endocrinol 2011;55/6 † ‡ *In T benefit. teamassessmentofriskand surgical multidisciplinary bariatric impliesathorough diabetes. Surgical referral ritization shouldbeassessedbyateamspecializingin optimal medicaltherapy. Conditionaleligibilityorprio- of diabetes and co-morbidity to and the response tory co-morbidity,associated weightrelated weighttrajec- should consider BMI, ethnicity,ritization for surgery orprioritized(Tableral isrecommended 9). andpointsatwhichrefer shouldbeconsidered surgery algorithms shouldnowincludepointsatwhichbariatric Diabetesmanagement has notbeenwidelyconsidered. asbestpracticeorprioritization tion ofsurgical referral eligiblefor surgery,those whoare - butarecommenda annually. treated than 2%ofeligiblepatientsare uptake,less countries withthehighestbariatricsurgery tly, optionaland,assuch,inthe isconsidered surgery - gorithms needsto be established (see below).Curren al- indiabetestreatment betes. Theplaceofsurgery therapyforobesepatientswithType 2dia- effective isavery isclearevidencethatbariatricsurgery There Diabetes –Whotoconsiderforsurgery? through responded adequatelytolifestylemeasures(metformin)withaHbA

Action pointsshouldbeloweredby2.5BMIpointlevelsforAsianpeople[74]. HbA able 9. Eligibility > 40kg⁄m < 30kg⁄m BMI range 35–40 kg⁄m 30–35 kg⁄m increasing, all 1c Contraindications for bariatric surgery include:cur Contraindications for bariatric surgery In patientswithType 2diabetes,eligibilityorprio- typicallyclassify Indications forbariatricsurgery

cases, > non-surgical 58 mmol 2 2

or patients 2 2

other ⁄ mol weight weight should (7.5%) and management responsive prioritization have despite Eligible for surgery Eligible forsurgery failed Yes–conditional fully co-morbidities programmes, to optimized Yes Yes No lose for weight bariatric conventional ‡ and not and achieving have † sustain anddiseasecontrol surgery 1c Type therapy, <53mmol⁄mol(7%). Yes–conditional Prioritized for targets significant 2 diabetes surgery based especially Yes No No on conventional that weight on if has failed ‡ weight loss not - - ther than being held back as a last resort. ther thanbeingheldbackasalastresort. earlyasanoptionfor eligible patients,ra- considered obesewithType 2diabetesshould be for theseverely gery. beargued thatbariatricsurgery It can therefore glycaemia iseasiertomanagefollowingbariatricsur hyper patients, residual sion (65,66).Intheremaining - thelikelihoodofremis increases Earlier intervention emia inthemajorityofpatientswithdiabetes(6,64). of hyperglyca can - lead to remission bariatric surgery isevidencethatweightlossinducedby loss andthere toachievesustainedandsignificantweight their efforts itshouldbeprioritized. where isanoptionandthecircumstances bariatricsurgery re as to whe- diabetes should include recommendations kg/m for Type 2diabetes whenthepatient’sBMIexceeds35 option asatreatment beconsidered bariatric surgery that the American Diabetes Association recommends Bycontrast, intreatment. ofbariatricinterventions role onthe ordirection littleinformation diabetes provide guidelinesforType 2 treatment Existing international Integration intodiabetestreatmentalgorithms by individualized optimizationofthemetabolic state, patient health would be recognized tes state. Improved ofthediabe- butremission, isnotcure, riatric surgery data,theachievablegoalofba- on thebasisofpresent definitionofsuccess and, needs tobeanagreed There Measuring diabetes-relatedoutcomes plications andco-morbidities. metabolicandothercom- Type 2diabetes,itsrelated of control achievingimproved potential savingsfrom follow-up,butalsothe andnecessary the procedures is essentialtoconsidernotjustthefinancialcostsof accesstobariatricsurgery, increasing from term butit limited. extremely are resources and healthcare rapidly increasing obesityare ratesofsevere tries where inthoseemerging coun- problems particular are There mostlikely tobenefit. nates againstindividualswhoare sity andType 2diabetesisnotequitableanddiscrimi- obe- forpeoplewithsevere access tosurgical treatment intheprivatesector. performed ped worldare Current inthedevelo- procedures majority ofbariatricsurgery vantaged peopleinthedevelopedworld,butvast commoninsocio-economically disad- Obesity ismore Equity ofaccesstobariatricsurgery Almost all severely obese patients are unsuccessfulin obesepatientsare Almost allseverely There will be resource implications in the short implicationsintheshort willberesource There 2 (63). Algorithms developed for treating Type 2 (63).Algorithmsdevelopedfortreating IDF positionstatement-bariatric surgery 377 - -

Copyright© ABE&M todos os direitos reservados. Copyright© ABE&M todos os direitos reservados. vement or remission ofobesity-associated co-morbidity.vement orremission - qualityof lifeandimpro sustained weightloss,improved including substantial success measures, plement broader 378 studies. longer-term safetyandefficacy larger-scale before technicalrefinements ly torequire glycaemia (72,73). improved Generally, studiesinhumanshavereported shortterm intestine. of asmallsegmentileumintotheproximal insubjectswithalowerBMI(70,71). less impressive butthesemaybe havebeenreported, glycaemic control in andimprovements clinical trialshavebeenperformed Roux-en-Ygastricbypass.Anumberof earlyhuman dard intestine, comparablewiththesegmentexcludedinastan- ofproximal portion is astomach-sparingbypassofshort and ilealinterposition(IT)(68). include duodenal-jejunal bypass(DJB)(67) procedures those withoutsignificantweightissues.Thesenovel mayevolveastherapyforType 2diabetes in cedures - Thesepro interventions. nefits ofthegastrointestinal be- to enhance the nonweight-loss glycaemic control chanism ofactionbariatricsurgery. Theaimhasbeen modelstoexamine theme- experiments usingrodent procedures elegant havedevelopedfrom Several novelprocedures bariatric-metabolic ovel N T state andsubstantialimprovement T metabolic state(Text box5). ofthe or improvement which involvesnormalization IDF positionstatement-bariatric surgery • • • Optimization ofthemetabolicstatemaybedefinedas: • A substantialimprovementinthemetabolicstatemaybedefinedas: • • • • • • ext box5Criteriaforremissionoroptimalmetabolic ype 2 diabetes: novel proceduresanddevices ype 2diabetes:novel The above definitions, with a focus on diabetes, com- These procedures remain experimental and are like- experimental andare remain These procedures Ileal interpositioninvolvesthesurgical transposition First describedbyRubino(69),duodenal-jejunalbypass pre-operated state blood pressure<135/85mmHgwithreducedmedicationfromthe LDL <2.3mmol/l HbA lowering ofHbA withminimalsideeffectswouldbeexpected) pre-surgery medications (wherearecontinued,reduceddosesfrom with reducedmedicationfromthepre-operatedstateorwithoutother > 15%weightloss blood pressure<135/85mmHg triglycerides <2.2mmol/l total cholesterol<4mmol/l;LDL2mmol/l no hypoglycaemia 1c ≤42mmol/mol(6%) 1c by>20% se peoplewithType 2diabetesisstilltobeestablished. inthemanagementofobe- of manytheseprocedures the efficacy,ce area, safety, durability and clinical utility sive thanmostconventionalbariatricsurgical procedures. less inva- considered Theseare results. others promising inadequateweight lossand with somedevicesproviding vestigation. Resultsinhumanstodatehavebeenmixed, alsounderin- devicesare tors, andvagalnerveblocking motilitystimula- gastricorgastro-duodenal electronic bypass. jejunumtomimictheduodenal-jejunal num andproximal mic theRoux-en-Ygastricbypass,orbypassduode tomi- upperjejunal area to bypassthegastro-duodenal sleeves band, whilesomeuseendoluminalimpervious adjustablegastric ofthelaparoscopic gastric restriction tract to mimic proximal to the upper gastrointestinal physically fixed Some endoscopically placed devices are gastricemptying. todelayorregulate trans-pyloric area or placedinthe in thestomachtomimicrestriction, placed of noveldevicesunderdevelopment,whichare ght lossduringtheperiodofplacement,plusarange 10%-15%wei- andwhichprovide have beenreported) beyond 2 years extending the duration of treatment for treatment placement (usually6months,butrepeat availablefortemporary currently balloons, whichare tract.Examplesincludeintra-gastric gastrointestinal include thesimplepositioningofadeviceinupper withsomecombiningapproaches. laparoscopic, endoscopicor uppergastrointestinal into thosethatare ral, the techniques can be divided by mode of placement onglucosetolerance.Ingene- non-weight-loss effects tative mechanismforalteringenergy balanceandfor tract’s pu- to utilize the gatrointestinal being explored devices Multiple, mostlynovel,devicesandtechniquesare bariatric-metabolic ovel N Management ofdiabetes(A) Recommend 1. 2. Whilst there isexcitementinthenovelmedical devi- Whilst there toplacenovel procedures A rangeoflaparoscopic devices Endoscopically placeduppergastrointestinal people withaBMIof30-35kg/m there areotherobesity-relatedco-morbidities. Undersomecircumstances recommended treatmenttargetswithmedical therapies,especiallywhere and obesity(BMIequaltoorgreaterthan35 kg/m isanappropriatetreatmentforpeoplewithTypeBariatric surgery 2diabetes iseconomically appropriate support services withits It isuptoeachhealthsystemdetermine whetherbariatricsurgery a tions 2 shouldbeeligibleforsurgery Arq Bras Metab. Endocrinol 2011;55/6 2 ) notachieving - Arq Bras Metab. Endocrinol 2011;55/6 Research recommendations Management ofdiabetes(B) forpersonswith Studiesareneededtoestablishthebenefitofsurgery 2. StudiesareneededtoestablishmorerobustcriteriathanBMI forpredicting 1. 11. There andfollow-up shouldbeaminimalaccepteddatasetforpre-surgery 10. Regional teamexperienceand surgicalexpertise,multidisciplinary Newbariatricproceduresrequirerobustassessmentfortheirefficacy, safety 9. Procedureselectionrequiresappropriateassessmentofrisk 8. 7. 6. 5. 4. 3. 13. It shouldberecognizedthataprolongedperiodofnormalization 12. All longitudinalstudiesshouldincludequalityoflifeasonetheoutcomes Studiesareneededtoestablishthelong-term complicationsofsurgery 7. Studiesareneeded toestablishthemechanismsofsuccesssurgery 6. Studiesareneeded toestablishthedurationofbenefitsurgery 5. Studiesarerequiredtodocumentthe courseofcomplicationsaftersurgery 4. Studiesareneededtoestablishwhetherbariatricprocedures preventorslow 3. • • • • • • • • • • • • • • diabetes andBMI<35kg/m procedures anddefinewhichpatientsbenefit mostfromwhich benefit fromsurgery to allowauditofclinicalprogrammes,forexample: bariatric procedures documented qualityoutcomesareimportantfactorsintheregionalchoiceof therapies andhavingregardstothebenefitsrisksofestablishedtherapy and durability, usingsimilarprinciplestothoseforassessingnewdrug options foranindividualpatient each operationaspartoftheprocessforselectingsurgicaltreatment be introducedwhensupportedbyanevidencebase should bestandardized.Othertechniques,variationsandnoveldevicescan should beexploredinresearchsettingsonly. Conventionalprocedures Apart fromconventionalproceduresnowinuse,newtechniquesanddevices provided topatientsaftersurgery Ongoing andlong-termnutritionalsupplementationsupportmustbe closely monitoredaftersurgery Glycaemic controlshouldbeoptimizedperi-operativelyand teams Patients shouldbeassessedandmanagedbyexperiencedmultidisciplinary reduce microvascularandcardiovascularrisk tomedicaltherapies shouldbeconsideredascomplementary Surgery glycaemic controlhasbenefitevenifthereiseventualrelapse and themechanismsassociatedwithrecurrence complications stabilizesandideallyimprovesmicrovascular to obtainevidencethatsurgery the progressivelossofB-cellfunctioncharacteristicType 2diabetes HbA auto-antibody status,e.g.anti-GADwhereavailable fasting C-peptidewhereavailable these shouldbeusedpreoperatively documentation ofmedications(glycaemia,lipidsandhypertension) foot exam(recent) blood pressuremeasurement lipid profile liver functionstests nephropathy (e.g.testformicroalbuminuriawithinpreviousyear) retinopathy status(recenteyeexamination) waist circumference BMI fasting glucoseandinsulin 1c

2

vs. benefitof manufacturer oftheSMARTmanufacturer fees from EliLilly,fees from ofByetta themanufacturer surgical registries recommended. recommended. surgical registries algorithms andtheestablishmentofnationalbariatric should beincorporatedintoType 2diabetestreatment ted forpeoplewithType 2diabetes.Bariatricsurgery needtobedevelopedandimplemen- bariatric surgery othermajorco-morbidities.National guidelinesfor are targets withmedicaltherapies,especiallywhenthere treatment tes andobesitynotachievingrecommended forpeoplewithType 2diabe- treatment appropriate an provides Surgery with an acceptable safety profile. therapyforType 2diabetesandobesity cost-effective and isan effective dical condition. Bariatric surgery me- obesityisacomplexandchronic Clinically severe Conclusion turer oftheLapBandSystem turer JDisaconsultantfor:Allergan Inc,manufac- Conflict ofinterest: riatric Advantage Wittert (University of Adelaide, Australia) and Joe Proietto (Uni- (UniversityofAdelaide, Australia)andJoeProietto Wittert andGary ofbariatricsurgery thecost-effectiveness reviewing therine Keating(DeakinUniversity, Australia)for Melbourne, Acknowledgments: We acknowledgethecontributions ofCa- Covidien. aneducational grantfrom has received ofNGBBiotech.Healso Board ontheScientificAdvisory serves RocheandCovidien grantsfrom research FR hasreceived GA hasnothingtodeclare. CovidienAustralia. aconsultingfeefrom PZ hasreceived Obesity Track). Quadrant Healthcom(ClevelandClinic’sMISSmeeting,Morbid and :Risksandbenefitsofearlyintervention); Diseasesin Hospital,ColumbusOhioUSA(Chronic Children’s pital, MiamiFloridaUSA(GastricBandingSummit);National forFloridaHos- ofeducationalprograms and asaco-director Australia Pharmaceuticals AbbottAustralasiaandNovartis from feesforthedevelopmentofeducational materials He hasreceived ofC-PAPNestle AustraliaandResMed,manufacturer machines. Allergan Inc, from forhisresearch support titute, havereceived &DiabetesIns- tions, MonashUniversityandBakerIDIHeart nical; Weight Watchers; Sharp&Dohme.Hisinstitu- andMerck ofXe- manufacturer ofOptifast;RocheProducts, manufacturer 11. Randomized controlledtrialsareneededtoevaluateandcomparedifferent 10. It todefinewhatwillbe willbeimportanttophenotype candidatesforsurgery Studiesareneededtodefinethebestregimensofdiabetesmanagement 9. Newtechniquesshouldbeassessedrigorouslyforefficacyandsafetyand, 8. well asemergingnonsurgicaltherapies bariatric proceduresforthetreatmentofdiabetesbetweenthemselves,as different agegroups,durationofdiabetes,etc. the mostappropriatebariatricprocedureforpersonswithdiabetesin post-bariatric surgery preclinical studies classical surgicaltechniques,movingtohumanstudiesafterappropriate ideally, mechanisms,anddemonstratetheirequivalenceorsuperiorityto  nutritional supplements; and Scientific Intake, nutritional supplements;andScientificIntake, IDF positionstatement-bariatric surgery   ; Metagenics, manufacturer ofBa- ; Metagenics,manufacturer device. He has received speakers’ speakers’ device.Hehasreceived  ; Nestle Australia, ; NestleAustralia, 379

Copyright© ABE&M todos os direitos reservados. Copyright© ABE&M todos os direitos reservados. 380 1. Referencs oftheposition statement ting andsubsequentformulation All panelmembersmadeasubstantialcontributiontothemee- (OHSU), USA M.Wolfe Bruce Professor HealthandScienceUniversity Oregon Belgium Dr. DiabetesFederation,Brussels, DavidWhitingInternational Antwerp UniversityHospital,Belgium LucVanProfessor Gaal Medicine, USA Collegeof PhilipR.SchauerClevelandClinicLerner Professor Catholic UniversityofRome,Italy Mingrone Gertrude Professor tion, Younde, Cameroon Diabetes Federa- Jean-Claude Mbanya International Professor Imperial CollegeLondon,UK Dr. le Roux Carel gium Diabetes Federation and University of Liege, Bel- International Lefebvre Pierre Professor pei, Taiwan Ming-Sheng GeneralHospital,NationalTaiwan University, Tai- Wei-JeiProfessor Lee Saifee Hospital,Mumbai,India Dr. Lakdawala Muffazal Peking UnviersityPeople’sHospital,China LinongJi Professor Atrium MedicalCenter, ParkstadHeerlen,theNetherlands Greve JanWillem Professor Dr. GelonezeUniverityofCampinas(UNICAMP), Brazil Bruno Ajou UniversitySchoolofMedicine,Korea NamH.Cho Professor University ofSydney, Australia LouiseA.Baur Professor King’s College,London,UK StephanieAmiel Professor Other attendeesatthemeetingwere: Australia Victoria, andDiabetesInstitute,Melbourne, Baker IDIHeart PaulZimmet Professor MedicalCollege,NewYork,Cornell NY, USA FrancescoRubinoWeillProfessor Australia Victoria, andDiabetesInstitute,Melbourne, Baker IDIHeart JohnB.Dixon Professor Imperial College,LondonandNewcastleUniversity, UK George Alberti Professor vened by: Belgium(5-6December 2010). Thismeeting was con- Brussels, in The IDFconsensusmeetingwasheldattheheadoffice of thispositionpaper. in the discussion or preparation These companies played no role NJ,USA. Inc.,MountLaurel, Cincinnati, OH,USA;MetaCure Inc., CA,USA;Ethicon,EthiconEndo-Surgery gan Inc,Irvine, educationalgrantby:Aller withanunrestricted was supported PaulZimmet(15).Theconsensusmeeting byProfessor chaired ofAustralianendocrinologists byagroup n provided directio this PositionStatement.We alsoacknowledgetheassistanceand of review Australia)fortheirconstructive versity ofMelbourne, IDF positionstatement-bariatric surgery

ClinPract. 2010;87:2-3. evidence, raisingawareness andpromotingaction.DiabetesRes Unwin N,GanD, Whiting D. The IDF Diabetes Atlas: providing - 18. 7. 1 16. 15. 14. 13. 12. 11. 10. 9. 8. 7. 6. 5. 4. 3. 2.

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