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
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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
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
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
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
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
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