Jaime Ponce MD, FACS, FASMBSDirector of Bariatric SurgeryHamilton Medical CenterDalton Georgia USA

LAGB Weight Loss and LAGB Weight Loss and DiabetesDiabetes

2010 Minimally Invasive Surgery SymposiumSan Diego CAFebruary 25, 2010

DisclosuresDisclosures

• Allergan:– Consultant, Proctor, Research, Speaker, use the

Lap-Band® in my private practice

• Ethicon Endo-Surgery:– Consultant, Proctor, Speaker, use the Realize™

Band in my private practice

Effects in Diabetes and Metabolic Effects in Diabetes and Metabolic SyndromeSyndrome

• Weight loss has a positive effect• LAGB programs with good understanding and

intense follow-up, have documented significant improvement in DM and Metabolic Syndrome

Change in Diabetes Status 1 Year After LAP-BAND System Surgery

Remission = Normal fasting glucose, HbA1c,* insulin, C-peptide, and no diabetes medication 32 patients (64%)

Improved = Significant improvement in control and reduction of diabetes medication 13 patients (26%)

No change = No change in diabetic control or therapy 5 patients (10%)

*At 1 year only 3 (6%) had HbA1c >7%.

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

Predictors of Remission

• Weight loss (% EWL)

– pr2 = 0.37, P<0.001

• Time with a diagnosis of diabetes

– pr2 = 0.24, P=0.003

– Combined pr2 = 0.44, P<0.001

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

Change with Weight Loss: HOMA %S

-40

-30

-20

-10

0

10

20

30

40

50

% C

hang

e

Change in % Insulin sensitivity

Normal fasting glucose Impaired fasting glucose Type 2 diabetes

Diabetic Medicine 2003;20:127-34.

Change with Weight Loss: HOMA %S & %B

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-30

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40

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% C

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Change in % Insulin sensitivity Change in % Beta-cell function

Normal fasting glucose Impaired fasting glucose Type 2 diabetes

Change with Weight Loss: HOMA %S & %B, HbA1c

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-30

-20

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% C

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Change in % Insulin sensitivity Change in % Beta-cell function Precentage change in HbA1c

Normal fasting glucose Impaired fasting glucose Type 2 diabetes

Change with Weight Loss: HOMA %S & %B, HbA1c

-40

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% C

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Change in % Insulin sensitivity Change in % Beta-cell function Precentage change in HbA1c

Normal fasting glucose Impaired fasting glucose Type 2 diabetes

Time with diabetes

R=-0.36, p=0.02

Fasting plasma glucose: Median +/- IQ range

3

4

5

6

7

8

9

10

11

12

Pre-operative 1-year 2-year 3-year 4 or more years

Diabetes

Impaired Fasting glucose

Normal Fasting glucose

* and ** are significantly different p<0.001 when grouped together

**

****

HTN and T2DM After LAGB in Glucose Intolerance Subjects

• Pontiroli, et al Univ of Milano, Italy: Diabetes Care Nov 2005;28:2703-9– 4-year case-controlled study in impaired Glucose-Tolerance pts: LAGB

vs conventional diet in prevention (56 vs 29 pts) and remission (17 vs 20 pts) of DM

– 73 LAGB pts vs 49 pts refused LAGB but agreed f/u with diet– BMI change: 45.9 to 37.7 vs 45.2 to 46.5

– Progression to T2DM: 0% vs 17.2%– Remission T2DM: 45% vs 4%

– Progression to HTN: 1.4% vs 25.6%– Remission HTN: 20.5% vs 2.3%

LAGB and Diabetes

• Dolan and Fielding. Obes Surg, 2004– 88 patients, BMI 45, Type II DM– 2 years after surgery

• 51% EWL• 65% patients off all medications (insulin, oral)

• 30% EWL by 6 months after surgery--> more likely to be off all DM medications

Resolution Rate of T2DMPonce, et al. Obes Surg (2004):14,1335-42

P<0.001 for >5 years vs <5 years at 12 and 18 months.

12 Months 18 Months

<5 Years’ Duration T2DM

Res

olu

tio

n R

ate

(%)

82.8%

33.3%

>5 Years’ Duration T2DM

90.9%

33.3%

n=35 n=18 n=22 n=12

All T2DM

n=53 n=34

66%70.5%

HbA1c in T2DM PatientsPonce, et al. Obes Surg (2004):14,1335-42

Preop 12 Months 18 Months

Hb

A1c (

%)

7.257.00

7.7

5.875.64

6.355.68

5.40

6.25

All T2DM Patients<5 Years’ Duration T2DM>5 Years’ Duration T2DM

.

n=35 n=17 n=22 n=11n=35 n=18n=53 n=52 n=33

%EWL in T2DM According to ResolutionPonce, et al. Obes Surg (2004):14,1335-42

Resolution

No Resolution

%E

WL 45.0%

27.0%

53.9%

27.5%

59.1%

26.5%

12 Months 18 Months 24 Months

n=35 n=17 n=24 n=9 n=12 n=3

P<0.001

P<0.001

P=0.005

Rates of DM resolution after Bariatric Operations

Parikh et al, NYU JACS 2007;205:631-5

LAGB (n=218); RYGB (n=53); BPD/DS (n=11)LAGB (n=218); RYGB (n=53); BPD/DS (n=11)

Swedish Band for the treatment of T2DM in Morbidly Obese

Brancatisano et al. SOARD 4(2008):423-9

Swedish Band for the treatment of T2DM in Morbidly Obese

Brancatisano et al. SOARD 4(2008):423-9

Change in Change in Glycosylated Hemoglobin (HbA1c)Glycosylated Hemoglobin (HbA1c)SAGB (2003-2006) US StudySAGB (2003-2006) US Study

Subjects with Hx of Diabetes

HbA1c (%) N Time

period Mean SD Range Change

Elevated 31 BL

36 mo 7.99 6.72

1.39 1.02

6.3 - 11.8 5.3 - 9.5

1.27*

Normal 14 BL

36 mo 5.51 5.73

0.34 0.26

5.0 - 6.1 5.4 - 6.2

0.21

Subjects without Hx of Diabetes

Elevated 17 BL

36 mo 6.75 5.81

0.69 0.24

6.2 – 8.4 5.3 - 6.1

0.94*

Normal 162 BL

36 mo 5.39 5.46

0.33 0.38

4.7 – 6.1 4.5 - 6.7

-0.07

Normal range for HbA1C 4.3-6.1%

* P <0.001 by t-test analysis

THE MANAGEMENT OF OBESITYTHE MANAGEMENT OF OBESITY

A PROSPECTIVE RANDOMISED CONTROLLED TRIAL OF A PROSPECTIVE RANDOMISED CONTROLLED TRIAL OF MEDICAL VERSUS SURGICAL THERAPYMEDICAL VERSUS SURGICAL THERAPY

Paul O’BrienPaul O’Brien, , John Dixon, Cheryl Laurie, Stewart Skinner, Joe Proietto, John McNeil, Boyd Strauss, Sharon Marks, Linda

Schachter, Leon Chapman and Margaret Anderson.. Centre for Obesity Research and Education Centre for Obesity Research and Education

Monash University, Melbourne, AustraliaMonash University, Melbourne, Australia

Annals of Internal Medicine, May, 2006Annals of Internal Medicine, May, 2006

RCT of Medical vs Surgical Therapy for Obesity % of Excess Weight Lost

8787%

21%21%

O’Brien et al, Ann Int Med. 2006O’Brien et al, Ann Int Med. 2006

RCT of Medical vs Surgical Therapy for ObesityEffect on Metabolic SyndromeEffect on Metabolic Syndrome

N.S.

P < 0.001P < 0.001

%%

38%

24%

38%

3%

Surgical Change vs Medical Change P < 0.006

O’Brien et al, Ann Int Med. 2006O’Brien et al, Ann Int Med. 2006

The Management of Type-2 DiabetesThe Management of Type-2 Diabetes

A Randomized Controlled Trial of A Randomized Controlled Trial of Surgical and Non-surgical TherapySurgical and Non-surgical Therapy

John B. Dixon, Paul E. O'Brien, Julie Playfair, Stewart John B. Dixon, Paul E. O'Brien, Julie Playfair, Stewart Skinner, Joseph Proietto, Linda M Schachter, Leon Skinner, Joseph Proietto, Linda M Schachter, Leon

Chapman, Margaret AndersonChapman, Margaret Anderson

Centre for Obesity Research and EducationCentre for Obesity Research and Education

Monash University, MelbourneMonash University, Melbourne

JAMAJAMA, Feb, 2008, Feb, 2008

Type-2 Diabetes – A Randomised TrialType-2 Diabetes – A Randomised TrialWeight Loss - % of excess weight lostWeight Loss - % of excess weight lost

6565%

6%6%

Type 2 Diabetes – A Randomised TrialType 2 Diabetes – A Randomised Trial

Weight Loss – Change in BMIWeight Loss – Change in BMI

36.336.3

28.428.4

37.137.1

Type 2 Diabetes – A Randomised TrialType 2 Diabetes – A Randomised TrialRemission of Diabetes - ITTRemission of Diabetes - ITT

73%73%

13%13%

Type-2 Diabetes – A Randomised TrialType-2 Diabetes – A Randomised Trial Effect on Metabolic Syndrome (ATP III criteria)Effect on Metabolic Syndrome (ATP III criteria)

(N.S.)

P < 0.001P < 0.001%%

97%

88%

97%

28%

Non-surgical vs Surgical Change P < 0.001

Buchwald diabetes meta-analysisThe American Journal of Medicine (2009) 122, 248-256

What is the mechanism of action?

• In RNY: – Schauer, et al (Ann Surg, 2003): 83% resolution,

only 30% had “immediate resolution” probably associated “hormonal effects”…concluded that resolution of diabetes was primarily “weight-loss driven”

– Weight regain may affect negatively diabetes remission

What is the mechanism of action?

• LAGB: – Reduced caloric intake– Weight loss

Thank YouThank YouHamilton Ambulatory Surgery CenterHamilton Ambulatory Surgery Center

Dalton, GADalton, GA