SchauerSurgeryforTDM糖尿病脂肪肝 .ppt
Role of Bariatric Surgery for Diabetes and Metabolic DiseaseCleveland ClinicCleveland ClinicBariatric and Metabolic InstituteBariatric and Metabolic InstituteEndocrinology,Diabetes and MetabolismEndocrinology,Diabetes and MetabolismPhilip R.Schauer,MDProfessor of Surgery,Cleveland Clinic Lerner College of MedicineDirector:Bariatric and Metabolic Institute(BMI)schauepccf.orgPresenterDisclosurePhilipR.SchauerMDBoard Member/Advisory Panel:SurgiquestConsultant:Ethicon,Lilly,Nestle,Novo Nordisk,Quadrant HealthCom,Inc.Research Support:Ethicon,NIHStock/Shareholder:Surgiquest,SEHQC LLC,ReMedyMDDr.Schauer does not intend to discuss any off-label use/unapproved use of drugs or devices ObesityWTheDiabetesEpidemic:GlobalProjections,20102030IDF.Diabetes Atlas 5th Ed.2011Obesity is a DiseaseDiabetes TreatmentLifestyle ModificationDrug TherapySurgeryA1C 7%52.5%BP 130/8051.1%LDL 100mg/dl56.2%All 3 18.8%NHANES data 2007-2010,n=4,926Bariatric Surgery Could Potentially Improve Success in Achieving all 3 Targets of Therapy Diabetes Care 2013Look AHEAD Study NEJM June 24,20137kg/10 yrsHbA1cNo changeAt 10 yrs Greater,longer sustained wt.loss is necessary to produce clinical benefit Introducing Surgery as a more effective treatment for T2DMBariatric/Metabolic Surgery 201455%35%8%2%Laparoscopic Open Safety of Bariatric Surgery in Obese PatientsWeighing benefits with risko30-day mortality 0.3%oMajor morbidity 4.3%oONE TENTH THE RISK OF CORONARY BYPASS SURGERYMost Common ComplicationsRoux-en-Y Gastric BypassEarly(30 Days)LateLeak with peritonitisStomal stenosis/stricturePulmonary embolism/DVTGastric ulcerBleedingDumping syndromeBowel obstructionBowel obstructionWound infectionIncisional herniaNausea/Vomiting/DehydrationCholecystitisPulmonary complicationsVitamin and mineral deficienciesCardiac complicationsWeight gainHypoglycemiaMoustarah et al.Current Surgical Therapy 10th Ed.Cameron 2010,Elsevier73 studies(3 RCTs)Journal of Obesity 2012NAFLD Stage:Before and After Bariatric SurgeryP=0.001ScorenN=70Results1st biopsy2nd biopsy at 8.5 monthsSevere steatosis,inflammation,and bridging fibrosisMild steatosis,no inflammation,and no fibrosisProcedure#studiesN(#patients)Histologic ResultRYGB12576Significant and consistent improvementAGB2441Improvement/no changeBPD2182Mostly improvement,worsening in pts with fibrosisVBG4303Mostly improvementWhat about the effect of surgery on Long-term Morbidity/MortalityHow Durable is the effect of surgery?Brethauer et al.Ann Surg 2013 SOS JAMA 2012 Look AheadSurgery associated with:Reduced all cause mortalityReduced CV events(fatal and nonfatal)Reduced Cancer mortality Reduced microvascular complicationsEffect on Long-term Mortality Compared to Non-Operated ControlsStudyProcedureF/UMortality ReductionMacDonald,1997RYGB9 yrs88%Flum,2004RYGB4.4yrs33%Christou,2004RYGB5 yrs89%Sowemimo,2007RYGB4.4 yrs50%Obrien,2006LAGB12 yrs73%Adams,2007RYGB8.4 yrs40%Sjostrom,2007VBG/other14 yrs31%Perry,2008(Medicare)RYGB,VBG,LAGB2 yrs48%age 65Maciejewski,2011RYGB6.7 yrsNone*RCTs Comparing Bariatric Surgery with Medical Therapy for T2DMPublished online March 31,2014Funded by Ethicon/NIHIntensive Medical TherapyIntensive Medical TherapyWeight management with diet and lifestyle Weight management with diet and lifestyle counseling per ADA clinical care guidelines*counseling per ADA clinical care guidelines*Insulin sensitizers,GLP-1 agonists,sulfonylureas Insulin sensitizers,GLP-1 agonists,sulfonylureas and multiple insulin injections utilized to target and multiple insulin injections utilized to target HbA1c 6%HbA1c 6%Scheduled visits with nutrition,psychology and Scheduled visits with nutrition,psychology and endocrinology per protocolendocrinology per protocolFollow-up visits every 3 months through year 2,and Follow-up visits every 3 months through year 2,and every 6 months for remaining follow upevery 6 months for remaining follow up*Standards of medical care in diabetes-2011.Diabetes Care;34 Suppl 1:S11-61 Bariatric Surgery Roux-en-Y Gastric Bypass Sleeve Gastrectomy Roux-en-Y Gastric Bypass Sleeve GastrectomyKashyap S,Schauer P,Bhatt D;Diabetes Obesity Metabolism 2010 Sep;12(9):833Baseline CharacteristicsBaseline CharacteristicsParameterParameterMedical Medical TherapyTherapy(n=40)(n=40)Bypass Bypass(n=48)(n=48)SleeveSleeve(n=49)(n=49)Age(yrs)Age(yrs)50.350.348.048.047.847.8FemalesFemales67%67%58%58%78%78%Duration of diabetes(yrs)Duration of diabetes(yrs)8.88.88.08.08.38.3HbA1c(%)HbA1c(%)9.09.09.39.39.59.5Body Mass Index (kg/mBody Mass Index (kg/m2 2)36.436.437.137.136.136.1 3 diabetes medications 3 diabetes medications61%61%52%52%46.9%46.9%Insulin useInsulin use51.2%51.2%46%46%44.9%44.9%DepressionDepression32%32%37%37%46%46%Microvascular complicationsMicrovascular complications20%20%42%42%29%29%Note:Based on analyzed populationSchauer et al.NEJM 2014Primary and Secondary Endpoints at 36 MonthsPrimary and Secondary Endpoints at 36 MonthsParameterParameterMedical Medical Therapy Therapy(n=40)(n=40)Bypass Bypass(n=48)(n=48)Sleeve Sleeve(n=49)(n=49)P P ValueValue1 1P P ValueValue2 2HbA1c 6%HbA1c 6%5%5%37.5%37.5%24.5%24.5%0.0010.0010.0120.012HbA1c 6%HbA1c 6%(without DM meds)(without DM meds)0%0%35.4%35.4%20.4%20.4%0.0010.0010.0020.002HbA1c 7%HbA1c 7%40%64.6%65.3%0.020.020.020.02Change in FPG(mg/dL)Change in FPG(mg/dL)-6-85.5-460.0010.0010.0060.006Relapse of glycemic Relapse of glycemic controlcontrol80%80%23.8%23.8%50%50%0.030.030.340.34%change inchange in HDL HDL+4.6+4.6+34.7+34.7+35.0+35.00.0010.0010.0010.001%change inchange in TG TG-21.5-21.5-45.9-45.9-31.5-31.50.010.010.010.011 Gastric Bypass vs Medical Therapy;2 Sleeve vs Medical TherapySchauer et al.NEJM 2014Change in HbA1cChangeinHbA1c(%)P0.001P0.001MedicalMedicalSleeve Sleeve Gastric BypassGastric BypassChange in Body Mass IndexChangeinBMI(Kg/M2)P=0.006P0.001P 3 321(52.5)21(52.5)28(58.3)28(58.3)19(38.8)19(38.8)Month 36NoneNone1(2.5)1(2.5)33(68.8)*33(68.8)*21(42.9)*21(42.9)*1-21-218(45)18(45)14(29.2)14(29.2)25(51)25(51)3 321(52.5)21(52.5)1(2.1)1(2.1)3(6.1)3(6.1)*P value 0.05 with Medical Therapy group as comparatorChange in Quality of Life MeasuresPhysicalFunctioningRoleLimitationsPhysical Health ComponentsMental Health Components*0.05 *0.001(Compared to IMT)*%*Summary:QOLChangesGastric Bypass:5/8 domains improvedSleeve Gastrectomy:2/8 domains improvedIntensive Med Rx:0/8 domains improvedBMI 950 patients,BMI 25-52)show that surgery results in superior glycemic control compared to medical Rx(up to 3 year follow-up)CV risk factors improved with surgerySurgery significantly improves quality of lifeSurgery reduces mortality/CV events(non-RCT,SOS)Perioperative morbidity 5%,mortality 7.0%)and Obesity(BMI 30)should be considered for bariatric surgeryTHANK YOU!Role of Bariatric Surgery for Diabetes and Metabolic DiseaseCleveland ClinicCleveland ClinicBariatric and Metabolic InstituteBariatric and Metabolic InstituteEndocrinology,Diabetes and MetabolismEndocrinology,Diabetes and MetabolismPhilip R.Schauer,MDProfessor of Surgery,Cleveland Clinic Lerner College of MedicineDirector:Bariatric and Metabolic Institute(BMI)schauepccf.org