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
-40
-30
-20
-10
0
10
20
30
40
50
% C
hang
e
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
-40
-30
-20
-10
0
10
20
30
40
50
% C
hang
e
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
-30
-20
-10
0
10
20
30
40
50
% C
hang
e
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