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MISS Journal Club 2012
RYGB/BPD-DS
Goal: to review 4 important and clinically relevant papers from 2011 on Gastric Bypass & BPD-DS
Objective
• GLP-1 levels and incretin effect on insulin secretion accounts for improved glycemic control after Gastric Bypass (GB)
• Long-term effect of GB is variable - diabetes re-emerges in up to 30%
• Aim: To characterize the magnitude & variance of the change of glucose & GLP-1 concentrations, and to identify determinants of glucose control, up to 2 years after GB
Methods• N=15
– 14 female– T2DM for 2.5 ± 2.5 years– HbA1c 7.1 ± 1.1%– BMI 43.7 ± 4.9– age 47.5 ± 9.1 years
• Evaluated preop and 1, 12, and 24 months after GB• Underwent a 50 g 3-hr OGTT followed by an
isoglylcemic iv glucose challenge (isoG IVGT) • Assessed mean changes and variances of each
parameter
Results
Results cont.
Results cont.
Results cont.
Results cont.
• Univariate analysis– Changes in glucose AUC over time were positively
associated with weight loss and negatively associated with HOMA-B and ISI composite
• Multivariate analysis– weight loss, HOMA-B, and ISI were determinants of
glucose AUC
• GLP-1 AUC was positively related to Insulin AUC
Discussion
Article #2
Archives of Surgery 2012; Jan 16.
Background
• 17 RYGB vs. LAGB comparative studies to date– 2 RCTs (Nguyen NT et al, Angrisani L et al)– 3 case-matched studies– 12 others
• Many methodological flaws in these studies– Small numbers, different patient populations
• Current study aim: compared RYGB to LAGB in matched pairs, treated during same time period, by same surgeons
Methods
• Inclusion criteria– BMI <50– Primary bariatric surgery only, no revisional cases– Min of 6 years follow-up (OR date <2005)
• RYGB and LAGB cases matched according to– BMI – Sex– Age
Methods• LAGB: LAP- BAND (BioEnterics) or Swedish Adjustable Gastric
Band (SAGB) • RYGB: retrocolic/retrogastric, 10-15mL pouch, ‘short’ BP limb,
100cm Roux limb
• Follow-up schedule: • LAGB
– monthly x 6 months, q2 months for 6 months, q3 months in Yr 2, q6 months thereafter
– band adjustments prn, Barium studies q18-24 months• RYGB
– 1 month, q3 months for Yr 1, q6 months thereafter • Labs annually, QoL assessment, food tolerance questionnaire
Outcome measures
• Weight loss: – ‘Excellent’ residual BMI <30– ‘Acceptable’ residual BMI <35– ‘Failure’ EWL<25% or residual BMI >35
• Early (<30 days) & late (>30 days) complications
• Reoperations
Results
• N=442– 221 LAGB patients vs. 221 RYGB patients
• Comparable sex ratio, age, BMI
• Follow-up rate @ 6 years: – 92.8% post-LAGB and 91.9% post-RYGB
Results
Weight loss• Maximal weight loss:
– LAGB: @ 36 months …64.8% EWL– RYGB: @ 18 months …78.5% EWL
p<0.001
Results
Failures (EWL<25%, BMI>35, or need for reversal/conversion)
– 3 years post-op• LAGB 31.7%• RYGB 6.9%
– 6 years post-op • LAGB 48.3%• RYGB 12.3%
p<0.001
p<0.001
Results• No mortality in either group• Early complications:
• RYGB 17.2%• LAGB: 5.4% ...... p<0.001
• Major morbidity (technical complications):• RYGB 3.6%
• LAGB: 2.2% ...... p=0.54
• Long-term complications/reoperations• RYGB 19.0% / 12.7%• LAGB: 41.6% / 26.7% ...... p<0.001
Results
Results
Overall, band removal necessary in 21.3% (n=47)
…of whom 13.1% (n=29) underwent a further bariatric procedure
Results
Quality of life • Improved in both groups• Quicker & greater improvement
after RYGB
Food tolerance • Better after RYGB• Worsened over time after LAGB
Results Comorbidity improvement Lipid profile:
Discussion
Article #3
Ann Intern Med 2011; 155(5):281-91.
Background
Gastric bypass (RYGB) vs. Duodenal Switch (DS)• Uncontrolled studies suggest that DS induces greater weight
loss than RYGB– Prachand et al, Ann Surg 2006– Marceau et al, Obes Surg 2007
• No RCT comparing these procedures
Aim• To conduct a randomized trial comparing RYGB vs. DS in
super-obese (BMI>50) …w.r.t. weight loss, CVD risk factors and QoL
Methods• Unblinded prospective randomized trial• 2 academic medical centers (Norway & Sweden)• N= 60 (RYGB=31, DS=29)* • Follow-up 2 years • Inclusion criteria:
– BMI 50-60– Age 20-50 years– Failed non-surgical weight loss attempts
• Exclusion criteria: – Previous bariatric or major abdo surgery– Severe cardiopulmonary disease, cancer, steroids
- Computer-derived
- Patient & surgeon masked to treatment allocation until 1wk prior to surgery
* Power calculation performed, based on retrospective data: needed minimum of 26 pts in each group to give 80% power to detect a significant difference in outcomes
Methods
Techniques• Standardized Laparoscopic techniques• RYGB
– 25ml pouch, 50 cm BP limb, 150 cm Roux limb, linear stapler
• DS– One-stage, Sleeve (30-32 F bougie), 100 cm common channel, 200 cm
alimentary limb, hand-sewn DI anastomosis
• Mesenteric defects not closed in either procedure • Routine postop diet • Follow-up: same for both procedures (phased diet, vitamins, ursodiol)
– Clinical follow-up @ 6 weeks, 6 months, 1 year, 2years
Methods
• Primary end-point– Change in BMI @ 2 years
• Secondary end-points– CV risk factors– Health-related QoL (SF -36)– Body composition (bioelectrical impedance analysis)
– Vitamin concentrations– Adverse events
Results
Results • Baseline characteristics … Similar for both groups
Data in mean ± 2SD, unless stated as %
RYGB (n=31) DS (n=29)Age, yrs 35.2 ± 7 36.1 ± 5.3
BMI, kg/m2 54.8 ± 3.2 55.2 ± 3.5
Female/male % 74/26 66/34
Diabetes % 16% 21%
HTN % 26% 28%CRP level 117 ± 81 138 ± 76
ResultsWeight loss at 2 years• DS was associated with greater weight loss
p<0.001
Mean Wt loss:
RYGB: 50.6kg
DS: 73.5kg
Results
Body composition• Significant reductions in both groups [RYGB vs. DS]
– Waist circumference: ↓36.7 cm vs. ↓51.5 cm, p<0.001
– Hip circumference: ↓31.7 cm vs. ↓45.6 cm, p<0.001
– Sagittal diameter: ↓11.8 cm vs. ↓14.6 cm, p<0.001
• All measure were significantly greater in DS group • DS patients lost significantly more fat mass and fat-
free mass
Results
Markers of CV risk– Blood pressure– Cholesterol– Fasting glucose– Insulin levels– CRP level
• Generally improved in both groups @ 2 yrs
• DS led to greater improvement in TC, LDL and HDL levels
Results
Adverse events• DS group had significantly more adverse
events overall, compared to RYGB group
– Overall complications … 62% vs. 32%, p=0.021
– Late (>30-day) complications … 41% vs. 29%, p=0.320
Results
Results
Vitamin concentrations • DS had lower Vitamin A and Vitamin D concentrations @ 2 yrs
Health-related QoL• RYGB: 7 of 8 subscores of SF-36 improved at 2 yrs• DS: 5 of 8 subscores of SF-36 improved at 2 yrs
Discussion
Article #4
Diabetes Care 2011; 34(3):561-567
Background
• Intensive glycemic control, achieved medically, does not reduce CV events in patients with well established DM– Actually assoc with higher mortality (ACCORD trial, PROactive trial)– <50% Diabetics are well controlled (ADA)
• Buchwald meta-analysis 2009: – Bariatric surgery led to remission/improvement of DM in 78%/87% – BPD superior to RYGB
• Authors have previously published high DM remission rates after BPD. No long term follow-up available
Aim
To assess the effect of BPD vs. Conventional Medical Therapy
on diabetic complications
Methods
• Longitudinal case-control study, not randomized• Single center (Rome)• N=110 obese patients (BMI>35), aged 25-60 years*• All had newly diagnosed T2DM (FBG >7.0mmol/L x2, or positive OGTT)
• 10 years follow-up• BPD & Conservative therapy groups matched for:
– Gender– Age– BMI– Cholesterol & Triglyceride levels– Smoking status
* Power calculation performed to calculate appropriate sample size…needed 30 in each group to give 90% power to detect a ΔGFR of 25%
Methods• Exclusion criteria:
– CV event in 6 months prior to enrollment – Advanced CCF– Severe angina– Creatinine >1.6mg/dL– Malignancy– Portal HTN
• ‘Run-in’ period – all subjects went on 3 month low cal diet prior to study group allocation
• ‘Conservative’ treatment – Sulphonylurea or insulin and/or metformin, supervised by a Diabetologist
• BPD – Open,
Methods
End-points • Primary
– % variation in GFR
• Secondary– Incidence of nephropathy, HTN, hyperlipidemia, CV events – % recovering from T2DM over 10 years follow-up – Change in weight, HbA1C, glucose, lipid profile, BP,
Framingham risk score– Change in insulin sensitivity measured only in BPD group
Results• 110 enrolled, only 50 met inclusion criteria/entered treatment
groups after 3 month diet• Baseline characteristics similar in both groups
Results
Early complications: • N=2 (9.1%) in BPD group • Respiratory infection n=1• Wound infection n=1
Late complications: • N=5 (22.7%) in BPD group• Incisional hernia n=3• Marginal ulcer n=2
Results
• Diabetic complications• Nephropathy (relative % variation in GFR):
– Deteriorated in controls (-45.6 ± 18.7%)– Marginally improved in BPD group (+4.2 ± 31.3%)
• % pts with microalbuminuria
Baseline 2 years 10 years
BPD 31.8% 9.1% 0% Controls 14.3% 28.6% All cases worsenedp-value 0.178 0.154 0.001
Results
• Progression from no nephropathy at study entry, to nephropathy at 10 yrs:– BPD group 9% – Controls 50%
p=0.002
ResultsCV events• BPD group n=0• Controls n=4 (3 MI’s, one stroke)
CV risk
Results
• Hypertension
• Hyperlipidemia
• Diabetes recovery
Baseline 10 years
BPD (n=22) 55% 0%
Controls (n=28) 64% 57%
Baseline 1 year 10 years
BPD 100% 0% 0%
Controls 100% 45% ?
Baseline 10 years
BPD (n=22) 64% 27%
Controls (n=28) 71% 75%
Prevalence
Results
• Weight changes
ResultsHbA1C
FBG
Discussion
