Transcript Slide 1

RYGB in the Treatment of Diabetes
Ricardo Cohen MD
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The Center of Excelence for the Surgical Treatment of Obesity and
Metabolic Disorder - Hospital Oswaldo Cruz, São Paulo, Brasil
Diabetes today..............
•Several new antidiabetic agents
•Insulin pumps
•Education
•Experts in Diabetes Centers
Around 55%of
pts are NOT
under control
The Case for RNYGB as a Treatment for
Uncontrolled T2DM
WHY RNY ?
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History - Used for a long time
Durability - long term FU with good results
Safety - low mortality - 0.3%
Reproducibility
Efficacy - high T2DM resolution rate
Physiology - better known mechanisms of
action (although not all)
Evidence: RNYGB for T2DM
Retrospective Studies
Prospective, Matched Controlled Studies
Prospective, Randomized Controlled
Studies- NEEDED, AGB study is the only
Meta-analysis Studies
Evidence-Based Metabolic Surgery for
Severely Obese Patients BMI > 35
T2DM and RYGB
Avg BMI=50; Avg HbA1c 9
Prospective, Matched Controlled Studies
“SOS STUDY”
Sjostrom L et al. N Engl J Med
2004;351:2683-93
N Engl J Med 2004;351:2683-93
“SOS STUDY”
Sjostrom L et al. N Engl J Med
2004;351:2683-93
Long-term Changes in Fasting Glucose and
Insulin
“SOS STUDY”
Sjostrom L et al. N Engl J Med 2004;351:2683-93
Meta-analysis Studies
Weight and Type 2 Diabetes after Bariatric
Surgery: Systematic Review and Meta-analysis
1990-2006; 19 studies, 4, 070 diabetic patients
Predictors of Resolution in Morbidly Obese Patients
Patient Factors and Outcomes
Associated with T2DM Resolution
(N=191)
Schauer et al. Annals of Surgery Oct 2003
Effects of RNYG on Metabolic Syndrome components
• What about the Metabolic Syndrome endpoints?
• HTN
• Hyperlipidemia
• HA1C
and Post-operative
characteristics
of patients (n=70)
(=70)
Effect Preof Bariatric
Surgeryclinical
on Metabolic
Syndrome
Preand Post-operative
clinical
characteristics
of patients (=70)
Weight (lbs)
Weight (lbs)
BMI (kg/m22)
BMI (kg/m )
Systolic blood pressure (mm Hg)
Systolic blood pressure (mm Hg)
Diastolic blood pressure (mm Hg)
Diastolic blood pressure (mm Hg)
Plasma glucose (mg/dl)
Plasma glucose (mg/dl)
HbA1c (%)
HbA1c (%)
Total cholesterol (mg/dl)
Total cholesterol (mg/dl)
Triglycerides (mg/dl)
Triglycerides (mg/dl)
HDL-C (mg/dl)
HDL-C (mg/dl)
LDL-C (mg/dl)
LDL-C (mg/dl)
AST (IU/l)
AST (IU/l)
ALT (IU/l)
ALT (IU/l)
Albumin (g/dl)
Albumin (g/dl)
Pre-operative
Pre-operative
339.1± 72.2
339.1± 72.2
56.0 ± 10.6
56.0 ± 10.6
134 ± 15
134 ± 15
79 ± 9
79 ± 9
138.5 ± 55.0
138.5 ± 55.0
7.69 ± 1.68
7.69 ± 1.68
201.4 ± 47.5
201.4 ± 47.5
170.7 ± 82.8
170.7 ± 82.8
44.8 ± 11.5
44.8 ± 11.5
121 ± 41.9
121 ± 41.9
30.9 ± 17.9
30.9 ± 17.9
37.3 ± 19.0
37.3 ± 19.0
3.87 ± 0.31
3.87 ± 0.31
Post-operative
Post-operative
235.5 ± 66.8
235.5 ± 66.8
38.5 ± 10.3
38.5 ± 10.3
124 ± 14
124 ± 14
75 ± 11
75 ± 11
98.3 ± 24.6
98.3 ± 24.6
5.91 ± 1.11
5.91 ± 1.11
173.2 ± 39.3
173.2 ± 39.3
109.9 ± 51.4
109.9 ± 51.4
47 ± 13.1
47 ± 13.1
108.1 ± 35.0
108.1 ± 35.0
24.2 ± 11.1
24.2 ± 11.1
32.7 ± 19.1
32.7 ± 19.1
3.81 ± 0.36
3.81 ± 0.36
Data are presented as mean ± standard deviation and n (%)
Data are presented as mean ± standard deviation and n (%)
p value
p value
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
0.006
0.006
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
0.04
0.04
0.005
0.005
0.003
0.003
0.06
0.06
0.19
0.19
What about effect of surgery on Long-term Mortality?
Effect on Long-term Mortality Compared to
Non-Operated Controls
Study
Procedure
F/U
Mortality
Reduction
MacDonald,1997
RYGB
9 yrs
88%
Flum, 2004
RYGB
4.4yrs
33%
Christou, 2004
RYGB
5 yrs
89%
Sowemimo, 2007
RYGB
4.4 yrs
50%
↓ 40% All Cause
↓ 49% CVD
↓ 92% Diabetes
Evidence: Surgery for BMI < 35
• LAGB
– O’brien/Dixon 1 (non-diabetic)
– Dixon/O’brien 2 (diabetic)
– Fielding et al
– Italian Registry
• Gastric Bypass
– Fobi et al
– Cohen et al
– Lee WJ et al
• BPD - Scopinaro, Chelini
LRYGB in BMIs 30-35
• April 2002- Feb 2008
• 127 patients/ 66 T2DM
• 28 - 63 years-old ( mean of 44)
LRYGB in BMIs 30 -35
127 Patients
BMI
30-31
31.1-32
32.1-33
33.1-34
34.1-34.9
Pts
24(19%)
33(26%)
39(31.5%)
19(15%)
12(8.5%)
T2DM
13
10
20
13
10
66 T2DM(52%)
Indications
• Uncontrolled T2DM after 12 mo of agressive medical
and behavioral treatment
• History of T2DM from 2 to 20 years
• Fasting C peptide over 1 that increases after a meal
challenge
Outcomes Criteria
• Resolution - A1c below 6.5%, no meds
• Improvement - A1c below 6.5%, less meds than
baseline
LRYGB, BMI 30-35
Cohen at al.
99 % between Resolution & Improvement
LRYGB, BMI 30-35
Cohen at al.
p=0.001
A1c
LRYGB, BMI 30-35
Cohen at al.
EWL, 72 months follow up
LRYGB, BMI 30-35
Cohen at al.
Significant
decrease-p<0.05
LRYGB, BMI 30-35
Cohen at al.
• CV risk factor (UKPDS Risk Engine)
http://www.dtu.ox.ac.uk/riskengine)
LRYGB, BMI 30-35
Cohen at al.
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No mortality
No leaks
No reoperations
4.5% minor complications( port site
hematomas, vomiting)
Conclusion
• In a patient with insulin resistance and some
preservation of beta cell function the RNY is
the best choice for BMI < 35 and > 30, so far
• The lowest threshold for BMI is unclear but
will best be designed by careful clinical trials
• The long history, safety profile and use for
other co-morbid illnesses make the RNY far
and away the best choice in the uncontrolled
type 2 diabetic of lower or higher BMIs
• Initial evidences of CV benefit
What’s our GOAL?
We want to be another “ARROW “
BMI > 30
Metabolic Surgery
Psychologic stability
12 month history of
uncontrolled DM/Metabolic
Syndrome