Dr. Chris CobournMedical Director and SurgeonSurgical Weight Loss Centre

Staff SurgeonTrillium Health CentreMississauga, Ontario

Consultant – Allergan Canada

There are an overwhelming number of patients with Type II DM

No single operation has been proven to be the best for all patients or we would be doing it

“My operation versus your operation” is not an effective means of winning the support of endocrinologists

All of these operations were designed as bariatric procedures to treat obesity

Caution is indicated if we are going to extend the indications and propose treatment for T2DM

Guidelines regarding the role of bariatric surgery for diabetes

NONE

● Bariatric surgery should be considered for adults with BMI > 35 kg/m2 and type 2 diabetes, especially if the diabetes is difficult to control with lifestyle and pharmacologic therapy. (B)

Although small trials have shown glycemic benefit of bariatric surgery in patients with type 2 diabetes and BMI of 30–35kg/m2, there is currently insufficient evidence to generally recommend surgery in patients with BMI < 35 kg/m2 outside of a research protocol. (E)

● The long-term benefits, cost effectiveness, and risks of bariatric surgery in individuals with type 2 diabetes should be studied in well-designed randomized controlled trials with optimal medical and lifestyle therapy as the comparator. (E)

DIABETES CARE, VOLUME 32, SUPPLEMENT 1, JANUARY 2009

LAPAROSCOPIC ADJUSTABLE LAPAROSCOPIC ADJUSTABLE GASTRIC BAND SURGERY GASTRIC BAND SURGERY (LAP-BAND)(LAP-BAND)

Most common bariatric procedure in

Europe, Australia, Canada,

Safest Bariatric Procedure -

Mortality 1:5000

No functional or structural

alteration of the GI tract

Adjustable

Reversible

Purely restrictive (satiety inducing),

no malabsorption

BAND ADJUSTMENTSBAND ADJUSTMENTS

8

Source: O’Brien et al. Obesity is a Surgical Disease: Overview of Obesity and Bariatric Surgery, ANZ J Surg, 2004; 74: 200-204.

0

5

10

15

20

25

30

0 1 2 3 4 5 6 7 8 9 10

Years

% W

eight

loss

Weight loss is more gradual than other bariatric procedures

Safest bariatric procedure Sustained weight loss Adjustable Commitment and Long Term Follow Up

are critical to success Patient and Physician both must be

committed Studies from low volume centres with

short follow up are not relevant

50 patients, Avg BMI 48 1 year EWL 38% Results: HbA1c, Fasting plasma glucose, Fasting

insulin, hypoglycemic medications or insulin

Remission 64% (32 pts) Improved 26% (13 pts) Unchanged 10% (5 pts)

3 (6%) has HbA1c > 7%

Dixon et al. Dixon et al. Diabetes CareDiabetes Care. 2002;25:358-363. 2002;25:358-363..

Diabetic pts wt loss is not as significant

as non diabetic cohort

Improvements in hypertension, NASH,

dyslipidemias, sleep disturbances, QOL

Weight loss did not alter need for

insulin

Improvement in B cell function was not

predictable and may correlate with

duration of T2DM

Dixon et al. Dixon et al. Diabetes CareDiabetes Care. 2002;25:358-363. 2002;25:358-363..

4-year case-controlled study LAGB vs Conventional Treatment

Group A – Impaired Glucose Tolerance – Prevention

56 LAGB , 29 Diet Progression to T2DM: 0% vs 17.2%

Group B - Type II DM - Remission 17 LAGB, 20 pts conventional treatment of T2DM Remission T2DM: 45% vs 4%

Dixon, Dixon, O’Brien et O’Brien et al, JAMA al, JAMA 20082008

Study Design:60 eligible participants (BMI> 30 and 40<kg/m2) with recently diagnosed (<2yrs) type 2 diabetes Prospective Randomized Controlled Trial

55 (92%) completed the program.

Treatment:Surgical – LAGB and routine post op careConventional – “best available medical practice for the treatment, education and follow up of patients with Type II DM”. Lifestyle modification included nutritional counseling, physical activity. Medical treatment including pharmaceutical for DM, weight loss, VLCD determined by physician

Main Outcome measure: Remission of type 2 diabetes (fasting glucose <7mmol/L and HbA1c<6.2% while taking no glycemic therapy)

Secondary measures included weight and components of the metabolic syndrome.

Table 1:Baseline characteristics of participants Surgery (n = 30) Conventional Therapy (n = 30)

Age, mean (SD) 46.6 (7.4) 47.1 (8.7)Men, No. (%) 15 (50) 13 (43)Hypertension, No. (%) 28 (93) 27 (90)Metabolic syndrome, No. (%) 29 (97) 29 (97)Coronary artery disease, No. (%) 0 1 (3)BMI, mean (SD) 37.0 (2.7) 37.2 (2.5)Weight, mean (SD), kg 105.6 (13.8) 105.9 (14.2)Waist circumference, mean (SD), cm 114.1 (10.2) 116.0 (10.0)Waist to hip ratio, mean (SD) 0.96 (0.09) 0.96 (0.10)Neck circumference, mean (SD), cm 41.8 (4.0) 42.4 (4.5)Blood pressure, mean (SD), mm Hg Systolic 136.4 (15.6) 135.3 (14.4) Diastolic 86.6 (9.4) 84.5 (9.8)HbA1c, mean (SD), % 7.8 (1.2) 7.6 (1.4)Plasma glucose, mean (SD), mg/dL 156.7 (38.5) 158.0 (48.7)Plasma insulin, median (IQR), μIU/mL 19.7 (16.5-27.5) 18.7 (13.7-30.7)Lipids, mean (SD), mg/dL Total cholesterol 201.8 (32.7) 198.2 (56.7) Triglycerides 190.6 (106.6) 188.7 (111.8) HDL-C 47.1 (10.1) 48.1 (11.1)Total cholesterol to HDL-C ratio 4.41 (0.87) 4.23 (1.11)

-5

0

5

10

15

20

25

30

Baseline 3-months 6-months 12-months 18-months 24-months

Months following randomization

Pe

rce

nta

ge

of

we

igh

t lo

ss

Surgical

Conventional

5

5.5

6

6.5

7

7.5

8

8.5

Baseline 6-months 12-months 18-months 24-months

Months after randomization

HbA

1c (

%)

Surgical

Conventional

Surgical

(N=29)

Baseline

Surgical

(N=29)

2 years

Conventional

Baseline

Conventional

2 years

No Therapy 2 26 4 8Metformin 28 3 26 18Other Oral 8 1 8 7Insulin 1 0 0 3Not known 0 1 0 4

Use of Diabetes Medications

Other- Surgical Baseline: Glimepride 3, Glicazide 5, Surgical 2-years; Glicazide 1Conventional Baseline: Glimepride 2, Glicazide 4, Glibenclimide 1, Rosiglitazone 1Conventional 2-years: Glimepiride 3, Glicazide 3, Glibenclimide 1

Variable Surgical

(N=29)

Conventional

(N=26)

95% CI of between group differences

P-value

HbA1c (%) 6.00 7.21(1.39)

Change (%) -1.81 (1.24) -0.38 (1.26) -2.1, -0.80 <0.001

Plasma Glucose

(mg/dl)

105.6 (30.3) 139.6 (38.1)

Change

(mg/dl)

-51.2 (37.6) -18.4 (41.2) -53.1 -12.3 0.002

Plasma Insulin (uIU/ml)

9.8 (4.7) 24.1 (13.6)

Change (uIU/ml) -12.4 (8.4) +1.0 (14.8) -19.6, -7.3 <0.001

Glycemic control – 2 Years Mean HbA1c and fasting plasma glucose levels were significantly lower in the surgical group at two years.

Weight loss – 2 YearsThis study showed that few achieved remission with a body weight loss of less than 10%, a level expected to produce important health benefits.

Variable Surgical

(N=29)

Conventional

(N=26)

95% CI of between group differences

P-value

Weight (kg) 84.6 (15.8) 104.8 (15.3)

Change -21.1(10.5) -1.5 (5.4) -23.8, -15.2 <0.001

Waist circum 95.8 (10.3) 112.7 (10.3)

Change -17.9(10.8) -4.0 (9.1) -19.0, -8.7 <0.001

Waist to Hip ratio

0.90 (0.06) 0.95 (0.08)

Change -0.06 (0.06) -0.01 (0.06) -0.07, -0.007 0/018

Surgical Conventional

P value

Remission 73% 13% <0.001

A1c 6.00 7.21Change A1c -1.81 -0.38 <0.00

1% Weight Loss

20.7 1.7 <0.001

% EWL 62.5 4.3 <0.001

LAGB assisted weight loss results in diabetes remission in the majority of subjects diagnosed for < 2-years

A percentage weight loss of greater than 10-15% provides a high likelihood of remission

Lifestyle measures are unlikely to achieve this weight loss

This is strong evidence to support the early consideration of surgically induced loss of weight in the management of obese patients with type 2 diabetes.

LAGB is the safest bariatric procedure with the lowest morbidity and mortality

Only Level 1 evidence to show efficacy in remission of Type II DM is with LAGB

Weight loss is more gradual than with other bariatric procedures

Remission of T2DM is more gradual Weight loss is sustained if LAGB delivered

in the context of a multi-disciplinary long term follow up program

LAGB is critically dependant on commitment and follow up on the part of both the patient and the clinic

Older studies with previous techniques and older technology are not relevant

Studies with low volume and poor follow up are not relevant

Obesity and Diabetes are chronic conditions and require sustained weight loss to be successful – short term outcomes are not relevant

There seems to be an early effect with duodenal exclusion procedures that we will hear about

However, the sustained resolution of diabetes is associated with sustained weight loss

Diabetes is a chronic condition so there is rarely a need or benefit to rapid resolution

If we are going to offer bariatric surgery for diabetes, we must offer safe and effective options in order to get buy in from endocrinologists

We are extending the limits of bariatric surgery so we should do it carefully and with good evidence

Dr. Chris CobournSurgical Weight Loss Centre

Trillium Health CentreMississauga, Ontario