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1、Role of Bariatric Surgery for Diabetes and Metabolic Disease,Cleveland ClinicBariatric and Metabolic InstituteEndocrinology, Diabetes and Metabolism,Philip R. Schauer, MDProfessor of Surgery, Cleveland Clinic Lerner

2、College of MedicineDirector: Bariatric and Metabolic Institute (BMI)schauep@ccf.org,Presenter Disclosure,Philip R. Schauer MDBoard Member/Advisory Panel: SurgiquestConsultant: Ethicon, Lilly, Nestle’, Novo Nordisk,

3、Quadrant HealthCom, Inc.Research Support: Ethicon, NIHStock/Shareholder: Surgiquest, SEHQC LLC, ReMedyMD,Dr. Schauer does not intend to discuss any off-label use/unapproved use of drugs or devices,ObesityWeek.com,The

4、Diabetes Epidemic: Global Projections, 2010–2030,IDF. Diabetes Atlas 5th Ed. 2011,,,Obesity is a Disease,,,,Diabetes Treatment,Lifestyle ModificationDrug TherapySurgery,NHANES data 2007-2010, n = 4,926,Bariatric Surge

5、ry Could Potentially Improve Success in Achieving all 3 Targets of Therapy,Diabetes Care 2013,Look AHEAD Study,NEJM June 24, 2013,7kg/10 yrs,HbA1cNo changeAt 10 yrs,Greater, longer sustained wt. loss is necessary to pr

6、oduce clinical benefit,Introducing Surgery as a more effective treatment for T2DM,Bariatric/Metabolic Surgery 2014,55%,35%,8%,2%,,Laparoscopic,Open,Safety of Bariatric Surgery in Obese Patients,Weighing benefits with ris

7、k,30-day mortality 0.3%Major morbidity 4.3%ONE TENTH THE RISK OF CORONARY BYPASS SURGERY,Most Common ComplicationsRoux-en-Y Gastric Bypass,Moustarah et al. Current Surgical Therapy 10th Ed. Cameron 2010, Elsevier,73 s

8、tudies (3 RCT’s),Journal of Obesity 2012,,NAFLD Stage: Before and After Bariatric Surgery,P =<0.001,Score,n,N=70,Results,1st biopsy,2nd biopsy at 8.5 months,Severe steatosis, inflammation, and bridging fibrosis,Mild

9、steatosis, no inflammation, and no fibrosis,What about the effect of surgery on Long-term Morbidity/ Mortality,How Durable is the effect of surgery?,Brethauer et al. Ann Surg 2013,SOS JAMA 2012,Look Ahead,Surgery associ

10、ated with:Reduced all cause mortalityReduced CV events (fatal and nonfatal)Reduced Cancer mortality Reduced microvascular complications,Effect on Long-term Mortality Compared to Non-Operated Controls,RCT’s Comparin

11、g Bariatric Surgery with Medical Therapy for T2DM,Published online March 31, 2014,Funded by Ethicon/NIH,Intensive Medical Therapy,Weight management with diet and lifestyle counseling per ADA clinical care guidelines*Ins

12、ulin sensitizers, GLP-1 agonists, sulfonylureas and multiple insulin injections utilized to target HbA1c ≤6%Scheduled visits with nutrition, psychology and endocrinology per protocolFollow-up visits every 3 months thro

13、ugh year 2, and every 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,Kashyap S, Schauer

14、P, Bhatt D; Diabetes Obesity Metabolism 2010 Sep;12(9):833,Baseline Characteristics,Note: Based on analyzed population,Schauer et al. NEJM 2014,Primary and Secondary Endpoints at 36 Months,,1 Gastric Bypass vs Medical Th

15、erapy; 2 Sleeve vs Medical Therapy,Schauer et al. NEJM 2014,Change in HbA1c,Change in HbA1c (%),P<0.001,P<0.001,MedicalSleeve Gastric Bypass,Change in Body Mass Index,Changein BMI (Kg/M2),P=0.006,P<0.001,P&l

16、t;0.001,MedicalSleeve Gastric Bypass,Change in Diabetes Medications,Schauer et al. NEJM 2014,Cardiovascular Medications atBaseline and Month 36,* P value <0.05 with Medical Therapy group as comparator,Change in Qu

17、ality of Life Measures,Physical Functioning,Role Limitations,Physical Health Components,Mental Health Components,**,**,* <0.05 ** <0.001 (Compared to IMT),**,*,*,%,%,*,*,Summary: QOL Changes,Gastric Bypass: 5

18、/8 domains improvedSleeve Gastrectomy: 2/8 domains improvedIntensive Med Rx: 0/8 domains improved,BMI < 35 vs. BMI ≥ 35Change in HbA1c,Adverse Events through 36 Months,No DeathsReoperations: 4 (sleave leak, gallst

19、ones, bleeding, abd pain),Adverse Events through 36 Months,Adverse Events through 36 Months,No Difference Between Groups,BMJ Oct 22, 2013,11 studies, 796 patients, BMI 27-53Surgery superior to med RxWt. loss, HbA1c, T2

20、DM remission, TG, HDL, remission of metabolic syndrome, QOL, medication reductionNo difference in BP or LDLNo CV events or death after surgeryAnemia (15%), Reoperation (8%),Surgical vs Medical Treatments for Type 2 Di

21、abetes Mellitus: A Randomized Clinical Trial Anita P. Courcoulas, MD, MPH; Bret H. Goodpaster, PhD; Jessie K Eagleton, MPH; Steven H. Belle, PhD, MScHyg; Melissa A. Kalarchia

22、n, PhD; Wei Lang, PhD; Frederico G. S. Toledo, MD; John M. Jakicic, PhDRoux-en-Y Gastric Bypass Surgery or Lifestyle With Intensive Medical Management in Patients With Type 2 Diabetes

23、 Feasibility and 1-Year Results of a Randomized Clinical TrialFlorencia Halperin, MD; Su-Ann Ding, MD; Donald C. Simonson, MD, MPH, ScD; Jennifer Panosian, BA; Ann Goebel-Fab

24、bri, PhD; Marlene Wewalka, MD; Osama Hamdy, MD, PhD; Martin Abrahamson, MD; Kerri Clancy, RN; Kathleen Foster, RN; David Lautz, MD; Ashley Vernon,

25、0;MD; Allison B. Goldfine, MD,2 More Recent RCT’sJAMA Surgery June 4, 2014,Both Show Superiority of Surgery vs. Intensive Medical RX,International Diabetes Federation Guidelines,Surgery should be an accepted o

26、ption in people who have type 2 diabetes and BMI of 35 or moreSurgery should also be considered as an alternative treatment option in persons with BMI 30 to 35 when diabetes cannot be adequately controlled by optimal me

27、dical regimen, especially in the presence of other major cardiovascular disease risk factorsIn Asian, and some other ethnicities of increased risk, BMI action points may be lower e.g. BMI 27.5 to 32.5,Bariatric Surgica

28、l and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes,Download at www.idf.org,Scientific Organizations with Guidelines/Position Statements that Support Metabolic Surgery for Treating T2D

29、M,SummaryBariatric Surgery for T2DM,14 RCT’s (>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 surgeryS

30、urgery significantly improves quality of lifeSurgery reduces mortality/CV events (non-RCT, SOS)Perioperative morbidity <5%, mortality < 0.3%,Conclusion Bariatric Surgery for T2DM,Patients with uncontrolled T2DM

31、(HbA1c >7.0%) and Obesity (BMI > 30) should be considered for bariatric surgery,THANK YOU!Role of Bariatric Surgery for Diabetes and Metabolic Disease,Cleveland ClinicBariatric and Metabolic InstituteEndocrinol