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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. Diabetes today. Several new antidiabetic agents Insulin pumps Education Experts in Diabetes Centers.
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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
Diabetes today.............. • Several new antidiabetic agents • Insulin pumps • Education • Experts in Diabetes Centers Around 55%of pts are NOT under control
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)
Evidence: RNYGB for T2DMRetrospective StudiesProspective, Matched Controlled StudiesProspective, Randomized Controlled Studies- NEEDED, AGB study is the onlyMeta-analysis Studies
Evidence-Based Metabolic Surgery for Severely Obese Patients BMI > 35
T2DM and RYGB Avg BMI=50; Avg HbA1c 9
Sjostrom L et al. N Engl J Med 2004;351:2683-93 “SOS STUDY” N Engl J Med 2004;351:2683-93
Sjostrom L et al. N Engl J Med 2004;351:2683-93 “SOS STUDY”
Long-term Changes in Fasting Glucose and Insulin “SOS STUDY” Sjostrom L et al. N Engl J Med 2004;351:2683-93
Weight and Type 2 Diabetes after Bariatric Surgery: Systematic Review and Meta-analysis 1990-2006; 19 studies, 4, 070 diabetic 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
Effect on Long-term Mortality Compared to Non-Operated Controls
↓ 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) • 98 women • 127 patients • 28 - 63 years-old ( mean of 44) • 98 women
LRYGB in BMIs 30 -35 127 Patients 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 30-35Cohen at al. 99 % between Resolution & Improvement
LRYGB, BMI 30-35Cohen at al. p=0.001 A1c
LRYGB, BMI 30-35Cohen at al. EWL, 72 months follow up
LRYGB, BMI 30-35Cohen at al. Significant decrease-p<0.05
LRYGB, BMI 30-35Cohen at al. • CV risk factor (UKPDS Risk Engine) http://www.dtu.ox.ac.uk/riskengine)
LRYGB, BMI 30-35Cohen at al. • 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
Metabolic Surgery What’s our GOAL?We want to be another “ARROW “ BMI > 30 Psychologic stability 12 month history of uncontrolled DM/Metabolic Syndrome