RYGB in the Treatment of Diabetes

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RYGB in the Treatment of Diabetes
Ricardo Cohen MD

• The Center of Excelence for the Surgical
  Treatment of Obesity and Metabolic Disorder -
  Hospital Oswaldo Cruz, São Paulo, Brasil

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Diabetes today..............

• Several new antidiabetic agents
• Insulin pumps
• Education
• Experts in Diabetes Centers

Around 55of pts are NOT under control
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The Case for RNYGB as a Treatment for
Uncontrolled T2DM
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WHY RNY ?

• 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)

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Evidence RNYGB for T2DMRetrospective
StudiesProspective, Matched Controlled
StudiesProspective, Randomized Controlled
Studies- NEEDED, AGB study is the
onlyMeta-analysis Studies
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Evidence-Based Metabolic Surgery for Severely
Obese Patients BMI gt 35
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T2DM and RYGB
Avg BMI50 Avg HbA1c 9
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Prospective, Matched Controlled Studies
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Sjostrom L et al. N Engl J Med 20043512683-93
SOS STUDY
N Engl J Med 20043512683-93
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Sjostrom L et al. N Engl J Med 20043512683-93
SOS STUDY
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Long-term Changes in Fasting Glucose and Insulin
SOS STUDY
Sjostrom L et al. N Engl J Med 20043512683-93
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Meta-analysis Studies
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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
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Predictors of Resolution in Morbidly Obese
Patients
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Patient Factors and Outcomes Associated with T2DM
Resolution (N191)
Schauer et al. Annals of Surgery Oct 2003
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Effects of RNYG on Metabolic Syndrome components

• What about the Metabolic Syndrome endpoints?
• HTN
• Hyperlipidemia
• HA1C

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Effect of Bariatric Surgery on Metabolic Syndrome
(n70)
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What about effect of surgery on Long-term
Mortality?
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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
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(No Transcript)
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? 40 All Cause
? 49 CVD
? 92 Diabetes
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Evidence Surgery for BMI lt 35

• LAGB
• Obrien/Dixon 1 (non-diabetic)
• Dixon/Obrien 2 (diabetic)
• Fielding et al
• Italian Registry
• Gastric Bypass
• Fobi et al
• Cohen et al
• Lee WJ et al
• BPD - Scopinaro, Chelini

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LRYGB in BMIs 30-35

• April 2002- Feb 2008
• 127 patients/ 66 T2DM
• 28 - 63 years-old ( mean of 44)
• 98 women
• 127 patients
• 28 - 63 years-old ( mean of 44)
• 98 women

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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)
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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

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Outcomes Criteria

• Resolution - A1c below 6.5, no meds
• Improvement - A1c below 6.5, less meds than
  baseline

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LRYGB, BMI 30-35Cohen at al.
99 between Resolution Improvement
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LRYGB, BMI 30-35Cohen at al.
p0.001
A1c
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LRYGB, BMI 30-35Cohen at al.
EWL, 72 months follow up
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LRYGB, BMI 30-35Cohen at al.
Significant decrease-plt0.05
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LRYGB, BMI 30-35Cohen at al.

• CV risk factor (UKPDS Risk Engine)
  http//www.dtu.ox.ac.uk/riskengine)

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LRYGB, BMI 30-35Cohen at al.

• No mortality
• No leaks
• No reoperations
• 4.5 minor complications( port site hematomas,
  vomiting)

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Conclusion

• In a patient with insulin resistance and some
  preservation of beta cell function the RNY is the
  best choice for BMI lt 35 and gt 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

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Whats our GOAL?We want to be another ARROW
BMI gt 30
Psychologic stability 12 month history of
uncontrolled DM/Metabolic Syndrome