Metabolic Surgery

Philip R. Schauer, MD Professor of Surgery, Cleveland Clinic Lerner College of Medicine

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Education and Research Support, Consulting •  NIH/NIDDK •  Ethicon Endosurgery •  Stryker Corporation •  Invacare Corporation •  Covidien •  Gore Corporation •  Bard/Davol Corporation •  Baxter Corporation •  Cardinal Health •  Surgical Excellence •  Barosense •  ReMedyMD •  SurgiQuest •  Quadrant Healthcare

www.ccf.org

INTRODUCING

www.obesityweek.com

Weight and Type 2 Diabetes after Bariatric Surgery: Systematic Review and Meta-analysis

1990-2006; 19 studies, 4, 070 diabetic patients

The American Journal of Medicine (2009) 122, 248-256

Journal of Obesity 2012

Shimizu et al. Journal of Obesity 2012

RCT’s Comparing Bariatric Surgery with Medical Therapy

for T2DM

RCT :LAGB vs. Med RX of DM

•  T2DM (< 2 yrs, HA1c 7.7%, no insulin)

•  60 patients (30 med RX, 30 surg Rx followed for 2 years)

•  BMI 30-40

•  Med RX +lifestyle vs. LAGB + Med Rx + lifestyle

•  Remission @ 2 yrs 13% vs 73% (p<0.001)

•  Wt. loss (%Initial BW) @ 2 yrs 1.7% vs. 20.7% (p <0.001)

•  No serious side effects in either group

Dixon et al. JAMA, Jan 23, 2008

LSG v RYGB BMI < 35 •  N= 60, BMI 25-35, Age 30-59, A1c >7.5%

Lee WJ et al Arch Surg, March 2011

Funded by Ethicon Endosurgery

Surgical vs. Medical Treatment of T2DM

Phil Schauer Sangeeta Kashyap

Objective

Compare the ability of intensive medical therapy vs. bariatric surgery to achieve biochemical

resolution of diabetes (HbA1c ≤6.0%) in overweight or obese patients

Endpoints

Success rate of achieving HbA1c ≤ 6%

Primary

Secondary

•  Change in fasting plasma glucose (FPG) •  Change in BMI •  Change in lipids, blood pressure, hs-CRP •  Change in medications •  Safety and adverse events

Intensive Medical Therapy •  Weight management with diet and lifestyle

counseling per ADA clinical care guidelines*

•  Insulin sensitizers, GLP-1 agonists, sulfonylureas and multiple insulin injections utilized to target HbA1c ≤6%

•  Scheduled visits with nutrition, psychology and endocrinology per protocol

•  Frequent home glucose monitoring and titration of medications for all patients

*Standards of medical care in diabetes--2011. Diabetes Care;34 Suppl 1:S11-61

Bariatric Surgery

Roux-en-Y Gastric Bypass Sleeve Gastrectomy

218 patients screened

"

50 Intensive medical���

therapy alone

50 Medical therapy

plus sleeve gastrectomy

" Population for Primary Analysis 41 50 49

150 randomized

STAMPEDE Trial: Flow of Patients

50 Medical therapy

plus gastric bypass

1 withdrew consent prior to surgery

7 withdrew consent 2 missed 9 and 12 month visits

• HbA1c >7.0% • BMI 27- 43 kg/m2

• Age 20-60 years

93% retention

Baseline Characteristics

Parameter Medical Therapy (n=41)

Bypass (n=50)

Sleeve (n=49)

Age (yrs) 50.7 48.3 47.8

Females 65% 58% 78%

Duration of diabetes (yrs) 8.6 8.2 8.3

HbA1c (%) 8.9 9.3 9.5

Body Mass Index (kg/m2) 36.8 37.0 36.2

Concomitant Medications ≥ 3 diabetes medications 61% 52% 46.9%

Insulin 51.2% 46% 44.9%

Lipid lowering agents 82.9% 86% 77.6%

Antihypertensive agents 75.6% 78% 67.3%

Note: Based on analyzed population

Primary and Secondary Efficacy Endpoints

Parameter Medical Therapy (n=41)

Bypass (n=50)

Sleeve (n=49)

P Value1

P Value2

HbA1c ≤ 6% 12% 42% 37% 0.002 0.008

HbA1c ≤ 6% (without DM meds) 0% 42% 27% <0.001 0.003

Change in FPG (mg/dL) -28 -87 -63 0.004 0.003

Change in BMI -1.9 -10.2 -9.0 <0.001 <0.001

% change in HDL +11.3 +28.5 +28.4 0.001 0.001

% change in TG -14 -44 -42 0.002 0.08

% change in hsCRP -33 -84 -80 <0.001 <0.001

1 Gastric Bypass vs Medical Therapy; 2 Sleeve vs Medical Therapy

IMT 8.9 7.7 7.1 7.4 7.5 RYGB 9.3 6.8 6.3 6.4 6.4 SG 9.5 7.1 6.7 6.7 6.6

Change in HbA1c

Change  in  HbA1c  (%)  

J

J

J

JJ

B

B

B B B

P

P

P PP

BaselineBaseline Month 3Month 3 Month 6Month 6 Month 9Month 9 Month 12Month 12-3.5-3.5

-3.0-3.0

-2.5-2.5

-2.0-2.0

-1.5-1.5

-1.0-1.0

-0.5-0.5

0.00.0

J IMTIMT

B RYGBRYGB

P SGSG

P<0.001 P<0.001

IMT 36.8 35.4 34.8 34.5 34.4 RYGB 37.0 31.8 28.2 26.9 26.8 SG 36.2 31.3 28.3 27.3 27.2

Change in Body Mass Index

Change  in  BMI  (Kg/M2)    

J

JJ

J J

B

B

B

B B

P

P

P

P P

BaselineBaseline Month 3Month 3 Month 6Month 6 Month 9Month 9 Month 12Month 12-12-12

-10-10

-8-8

-6-6

-4-4

-2-2

00

J IMTIMT

B RYGBRYGB

P SGSG P<0.001 P<0.001

IMT 2.8 3.1 3.1 3.0 3.0 RYGB 2.6 1.1 0.6 0.4 0.3 SG 2.4 1.1 0.9 0.8 0.9

Average Number of Diabetes Medications

Average  Number  

of  Medica>ons  

J

J JJ J

B

B

BB

B

P

P

PP

P

BaselineBaseline Month 3Month 3 Month 6Month 6 Month 9Month 9 Month 12Month 120.00.0

0.50.5

1.01.0

1.51.5

2.02.0

2.52.5

3.03.0

3.53.5

J IMTIMTB RYGBRYGBP SGSG P<0.001

P<0.001

Percentage of Patients on Insulin

J

J

J

J J

B

B

BB

B

P

P

P

P

P

BaselineBaseline Month 3Month 3 Month 6Month 6 Month 9Month 9 Month 12Month 1200

1010

2020

3030

4040

5050

6060

J IMTIMT

B RYGBRYGB

P SGSG

%  Pa>ents  

IMT 51.2 55.0 42.5 38.5 38.5 RYGB 46.0 26.0 10.0 8.3 4.1 SG 44.9 16.3 6.1 2.1 8.2

Cardiovascular Medications at Baseline and Month 12

CV medications – number (%)

Medical Therapy (n=41)

Bypass (n=50)

Sleeve (n=49)

Baseline

None 0 (0) 3 (6.0) 2 (4.1)

1 7 (17.1) 5 (10.0) 12 (24.5)

2 15 (36.6) 12 (24.0) 16 (32.7)

> 3 19 (46.3) 30 (60.0) 19 (38.8)

Month 12 None 0 (0) 24 (49.0) * 20 (40.8) *

1 3 (7.7) 13 (26.5) 17 (34.7)

2 13 (33.3) 10 (20.4) 5 (10.2)

> 3 23 (59.0) 2 (4.1) 7 (14.3)

* P value <0.001 with Medical Therapy group as comparator

Adverse Events

Parameter Medical Therapy (n=43)

Bypass (n=50)

Sleeve (n=49)

IV treatment for dehydration 0 4 (8) 2 (4)

Re-operation 0 3 (6) 1 (2)

Gastrointestinal Leak 0 0 1 (2)

Transfusion 0 1 (2) 1 (2)

Anastomotic ulcer 0 4 (8) 0

Hypoglycemic episode (self-reported) 35 (81) 28 (56) 39 (80)

Hypokalemia 1 (2) 2 (4) 2 (4)

Anemia 3 (7) 6 (12) 6(12)

Summary •  Bariatric surgery was more effective than intense medical

therapy in achieving glycemic control (hbA1c < 6.0%).

•  Many surgical patients achieved glycemic control without use of any diabetic medications.

•  Cardiovascular risk factors (HDL, triglycerides, hsCRP, BMI) showed greater improvement after surgery.

•  Many surgical patients were able to reduce the number of CV medications.

Schauer et al. NEJM 2012

Conclusion Bariatric surgery (gastric bypass or sleeve

gastrectomy) may be considered as a treatment option for patients with uncontrolled T2DM and moderate to severe obesity (BMI > 30 Kg/M2)

Schauer et al. NEJM 2012

Mingrone et al. NEJM 2012

Results: Primary Endpoint, HA1c

2012: The Year of Metabolic Surgery���Recent Relevant Publications

SOS JAMA 2012

A

5

6

7

8

9

10

11

0 6 12 24 48 60 72

Months After Surgery

Hemoglobin

A1c

(%)

Cohen RV….. Cummings DE Diabetes Care (in press)

Rapid & Durable Improvement in HbA1c After RYGB in BMI 30-35

N=66,100% follow-up

2011  Interna>onal  Diabetes  Federa>on  Guidelines    •  Bariatric  surgery  is  an  appropriate  treatment  for  people  with  type  2  

diabetes  and  obesity  not  achieving  recommended  treatment  targets  with  medical  therapies,  especially  when  there  are  other  major  co-­‐morbidi<es.    

 •  Surgery  should  be  an  accepted  op<on  in  people  who  have  type  2  diabetes  

and  BMI  of  35  or  more  

•  Surgery  should  also  be  considered  as  an  alterna<ve  treatment  op<on  in  persons  with  BMI  30  to  35  when  diabetes  cannot  be  adequately  controlled  by  op<mal  medical  regimen,  especially  in  the  presence  of  other  major  cardiovascular  disease  risk  factors  

 •  In  Asian,  and  some  other  ethnici<es  of  increased  risk,    

BMI  ac<on  points  may  be  lower  e.g.  BMI  27.5  to  32.5    

 

Bariatric  Surgical  and  Procedural  Interven<ons  in  the  Treatment  of  Obese  Pa<ents  with  Type  2  Diabetes  

Download at www.idf.org

Conclusion •  3 RCT’s show surgery results in superior

glycemic control compared to medical Rx •  CV risk factors improved with surgery •  Weight loss is a major driver of

improvement •  Patients with uncontrolled T2DM (HbA1c

>7.0%) and Obesity (BMI > 30) and should be considered for bariatric surgery

MISS  2013:  Las  Vegas  

FEBRUARY  21-­‐23,  2013  

Year Venue

2001 Snowbird, UT

2002 Beaver Run, Breckenridge, CO

2003 Squaw Creek, Lake Tahoe, Calif

2004 Whistler, British Columbia

2005 Squaw Creek, Lake Tahoe, Calif

2006 Vail Cascade, CO

2007 Snowbird, UT

2008 Steamboat, CO

2009 Harrah’s, Lake Tahoe, NE

2010 Marriott Marina, San Diego, Calif

2011 Grand America Hotel, Salt Lake City

2012 Grand America Hotel, Salt Lake City

2013

www.miss-cme.org