Debate: What’s the Best Way to Treat Obesity in Type 2 ......... What’s the Best Way to Treat Obesity in Type 2 Diabetes? Lee M. Kaplan, MD, ... The key to optimizing clinical

Debate: What’s the Best Way to Treat Obesity in Type 2 Diabetes? Lee M. Kaplan, MD, PhD Osama Hamdy, MD, PhD

Sunday, February 19, 2017 8:00 a.m. – 9:00 a.m.

Lee M. Kaplan, MD, PhD Despite multiple, concerted public health, behavioral and medical initiatives, effective prevention and durable control of obesity have proven elusive. Indeed, rates of obesity continue to rise worldwide, and no country or region has seen a significant, sustained reduction in either obesity prevalence or severity during the past several decades. Given its serious, pleiotropic effects on health, new strategies for prevention and treatment of obesity are needed. This is particularly true for patients with type 2 diabetes. In these patients, where obesity reduction is strongly beneficial for controlling the diabetes, most anti-obesity therapies are even less effective than in patients with normal glucose and lipid metabolism. One potential explanation for the limited effectiveness of most anti-obesity therapies is the heterogeneity of obesity itself. With several thousand genes and several hundred biological pathways contributing to the normal regulation of fat mass and body weight, it stands to reason that different defects in these regulatory systems may produce different subtypes of obesity. These different subtypes are manifest by distinct phenotypes, including differences in age of onset, body fat distribution, response to specific obesogenic environmental factors, associated comorbidities, and response to individual therapies. Optimizing outcomes in obesity treatment requires identifying the therapy or therapies that are most effective for an individual patient. With respect to diet-based treatments, many patients respond to a diet with fewer processed foods. For some, a low-carbohydrate or low-glycemic index diet is most effective, and for others, a fat-restricted diet yields better results. Similarly variable responses are seen to other lifestyle-based, pharmacological and surgical therapies for obesity. The key to optimizing clinical success comes in learning to apply each available therapeutic modality effectively, safely and confidently. Doing so will give each patient the greatest opportunity to receive the treatment that most closely matches their clinical need. Osama Hamdy, MD, PhD

Weight reduction through lifestyle modifications remains the cornerstone in preventing and managing type 2 diabetes among overweight and obese individuals. For a long time, physicians have been skeptical about the long-term maintenance of weight reduction—claiming that nonsurgical weight reduction is always temporary and is frequently followed by gradual weight regain to the starting baseline. Over the last 2 years, this view has been gradually changing. Recent clinical trials and novel clinical practice models showed that long-term maintenance of weight loss is not only possible but is also associated with significant long-term improvement in many of the metabolic and cardiovascular abnormities seen in patients with type 2 diabetes. Over the past 5 years, the introduction of several diabetes medications that induce satiety and reduce food intake (eg, glucagon-like peptide 1 analogues, SGLT-2 inhibitors and amylin analogues) gave clinicians several additional tools that allow them to help their patients in achieving better diabetes control without compromising their body weight Use of these medications in proper combinations can help patients with type 2 diabetes not only to lose weight but also to maintain the weight loss. The Why WAIT (Weight Achievement and Intensive Treatment) program showed that it is possible for patients with obesity and diabetes to maintain weight reduction for up to 5 years in real-world clinical practice. On contrary, data from bariatric surgery mainly came from poorly designed studies with a smaller number of participants and for

relatively shorter duration. Variable definition of diabetes remission as shown in surgical intervention studies falsely augmented their results and misled physicians and patients. Cost-effectiveness and safety of bariatric surgeries for obesity management in diabetes are questionable. References: 1. Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan

DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346 (6):393–403.

2. Nathan DM, Buse JB, Davidson MB, et al. Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy. Diabetes Care 2008;31 (12):1–11.

3. Mitri J, Hamdy O. Diabetes medications and body weight. Expert Opin Drug Saf. 2009;8(5):573–84

4. Hamdy O, Carver C. The Why WAIT program: improving clinical outcomes through weight management in type 2 diabetes. Curr Diab Rep. 2008;8(5):413–20

5. Hamdy O, Mottalib A, Morsi A, El-Sayed N, Goebel-Fabbri A, Arathuzik G, Shahar J, Kirpitch A, Zrebiec J. Long-term effect of intensive lifestyle intervention on cardiovascular risk factors in patients with diabetes in real-world clinical practice: a 5-year longitudinal study. BMJ Open Diabetes Res Care. 2017;5(1):e000259.

64th ADA Postgraduate Course

Treatment of Type 2 Diabetes Mellitus:Medical and Surgical Options

Lee M. Kaplan, MD, PhD

Obesity, Metabolism & Nutrition InstituteMassachusetts General HospitalHarvard Medical School

[email protected]

February 19, 2017Fernando Botero, 1932-

Relationship between Obesity and Type 2 Diabetes

Chan J, et al., Diabetes Care 1994; Colditz G et al., Ann Int Med 1995

0

5

10

15

20

25

30Drug (Liraglutide)

Weight Loss Varies Widely Among Patients

0

5

10

15

20

25

30

Diet (Low-carbohydrate)

Surgery (Gastric Bypass)Device (Duodenal liner)

0

5

10

15

20

25

30

10-1

5 G

ain

5-10

Gai

n

0-5

Gai

n

0-5

5-10

10-1

5

15-2

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20-2

5

25-3

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30-3

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45-5

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5

10

15

20

25

30

10-1

5 G

ain

5-10

Gai

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Gai

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5

15-2

0

20-2

5

25-3

0

30-3

5

35-4

0

40-4

5

45-5

0

>50

Pat

ien

ts (

%)

Pat

ient

s (%

)

Pounds Lost 2

Considerable Variation in Response Within Diets

Zone DietAtkins Diet

0

10

20

30

>10%Gain

5-10%Gain

0-5%Gain

0-5% 5-10%

10-15%

15-20%

20-25%

25-30%

0

10

20

30

>10%Gain

5-10%Gain

0-5%Gain

0-5% 5-10%

10-15%

15-20%

20-25%

25-30%

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10

20

30

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5-10%Gain

0-5%Gain

0-5% 5-10%

10-15%

15-20%

20-25%

25-30%

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20

30

>10%Gain

5-10%Gain

0-5%Gain

0-5% 5-10%

10-15%

15-20%

20-25%

25-30%

LEARN Program Ornish Diet

Weight Change Weight Change

Weight Change Weight Change

AdaptedfromGardneretal,JAMA2007

Pounds Lost FGF21 - 1

Anti-Diabetes Medications and Obesity

MedicationEffects on

Body Fat

Predicted Effects on

Diabetes Progression

Insulin Protective

Sulfonylureas Accelerant

Thiazolidinediones Protective

SGLT-2 inhibitors Mildly Protective

Metformin Protective

GLP-1 agonists Mild Accelerant

Amylin agonists Unknown


Body Fat



Insulin Protective





GLP-1 agonists Mild Accelerant


Body Fat



Insulin Protective






Body Fat



Insulin Protective





Body Fat



Insulin Protective




Body Fat



Insulin Protective



Body Fat



Insulin Protective


Body Fat



Metabolic Surgery

VerticalSleeve

Gastrectomy

Roux-en-Y GastricBypass

Weight-independent Metabolic Benefits

Adjustable GastricBanding

Biliopancreatic Diversion /

Duodenal Switch

8% 48% 42% 2%

Worldwide use:

Average Effectiveness of Obesity Treatments

-50

-40

-30

-20

-10

0

0 2 4 6 8 10

Per

cent

Tot

al W

eigh

t Los

s

Time After Surgery (years)

Lifestyle &Medications

GastricBanding

GastricBypass

Swedish Obesity SubjectsDiabetes Prevention Program

2%

13%

27%

RYGB Induces System-wide Physiological Changes

LDL

HDL

Cholesterol

Hunger

Energy expenditure

Energy Balance

Bile acids

∆ Gut microbiota

GI factors

Sweet preference

Fat preference

Taste

GLP‐1

PYY

Hormones

Ghrelin

Leptin

Beta cell function

Insulin sensitivity

Glucose Homeostasis

Bariatric Surgery Reduces T2DM Incidence

Carlsson LMS, et al. N Engl J Med 2012; 367:695

Swedish Obesity Subjects (SOS) Study

Diabetes Improvement After Bariatric Surgery

Cha

nge

in H

bA1c

(%

)C

han

ge in

HbA

1c (

%)

Time (months)

Time (years)

Schauer et al., 2014

Courcoulas et al., 2015

HbA

1c (

%)

Medical management

Gastric bypass

Time (months)

Ikramuddin et al., 2013

Gly

cate

d H

b (%

)

Time (months)

Mingrone et al., 2012

Randomized Controlled Trials

Long-term Weight Loss after Bariatric Surgery

Mingrone G, et al., Lancet 2015

Long-term Weight Loss after Bariatric Surgery

Schauer PR et al., NEJM 2017

STAMPEDE Trial (RCT)

Long-term Improved Glycated Hemoglobin


STAMPEDE Trial

Anti-Diabetes Medication Use after Bariatric Surgery


STAMPEDE Trial

Months Following Randomization

Benefits of Bariatric Surgery are Not BMI Dependent


STAMPEDE Trial

DSS-IIPrimary Sponsors

Guidelines endorsed by 45 medical and surgical societies

Consensus Panel

• 45 members

• 75% internists and endocrinologists

• 25% surgeons

Surgery for the Treatment of Type 2 Diabetes

Surgery is recommended for:

• BMI ≥ 40 regardless of glycemic control

• BMI ≥ with inadequately controlled hyperglycemia

Surgery should be considered for:

• BMI 30-35 with inadequately controlled hyperglycemia

• Asians with BMI 27.5-35 with inadequately controlled hyperglycemia

Recommendations of DSS-II (2016)

Conclusions

• Diet and exercise are critical components of lifestyle-based therapies; they are not the only components, however

• All anti-diabetes therapies exhibit substantial patient-to-patient variation in effect

• There are genetic and other biological factors that determine which diets are most effective in individual patients

• Even for lifestyle therapies, one size doesn’t fit all

Lifestyle-based Therapies

Conclusions

• On average, anti-diabetes medications are highly effective in the treatment of diabetes, far more effective than lifestyle therapy alone

• Some medications, however, can exacerbate underlying obesity

• Some medications may accelerate the progression of underlying beta cell failure

Pharmacotherapy

Conclusions

• Metabolic surgery provides substantial, long-term improvement in type 2 diabetes

• While risk and cost of surgery preclude its use as first-line therapy, it is likely underused as “rescue” therapy

• The optimal use of surgery in the pathway of care for type 2 diabetes remains to be determined

Surgical Therapy

Conclusions

• Lifestyle, medical and surgical care for both obesity and type 2 diabetes should be viewed as cooperative, not competitive, approaches

• New patient care models that promote integrated pathways and shared medical and surgical responsibility for care within those pathways (including post-operative care) should be encouraged

• Use and optimization of combination therapies that employ all available approaches need to be supported and further evaluated

Coordinated Care

Clinical Data Evaluation – A Serial Approach

• Statistical significance

• Effect size

• Number needed to treat

• Durability of effect

• Risk-benefit profile

• Cost-benefit profile

64th ADA Postgraduate Course

Treatment of Type 2 Diabetes Mellitus:Medical and Surgical Options

Lee M. Kaplan, MD, PhD

Obesity, Metabolism & Nutrition InstituteMassachusetts General HospitalHarvard Medical School

[email protected]

February 19, 2017Fernando Botero, 1932-

The Best Management of Obesity in Type 2

Diabetes

Osama Hamdy, MD, PhD, FACE

Medical Director, Obesity Clinical Program,Director of Inpatient Diabetes Management,Joslin Diabetes CenterHarvard Medical School Boston, USA

Evolution of History

2017 B.C. 2017 A.C.

After Weight-Loss Surgery, a Year of Joys and DisappointmentsEven as the pounds fell away and their health improved, two patientscontended with the feeling that life hadn’t changed as much as they’d hoped.

After Weight-Loss Surgery, a Year of Joys and DisappointmentsEven as the pounds fell away and their health improved, two patientscontended with the feeling that life hadn’t changed as much as they’d hoped.

December 27, 2016

September 11, 2016

Before You Spend $26,000 on Weight-Loss Surgery, Do ThisThe old-fashioned way to treat diabetes. It is cheaper than weight-loss surgery. And probably more effective

We are in agreement

1- Anti-obesity medications are effective for weight reduction2- Bariatric surgeries are indicated for patients with very high BMI (Class III obesity)3- Gastroscopic procedures are promising

Lorcaserin in yr 1, placebo in yr 2

Placebo yr 1 and 2

102

98

96

90

0

Body Weight (Kg)

0

Study Week

8 16 24 32 40 48 56

92

94

100

Lorcaserin in yr 1 and 2

64 72 80 88 96 104

Year 1 Year 2

Average 1-year weight loss is 5.8 kg

Placebo 2.2 Kg (p<0.001)

55.4% on lorcaserin

45.1% on placebo completed year 1

Results of Bariatric Surgery

Is this true?

Is this true?

What is the Reality without Bariatric Surgery Propaganda?

6 Claims:1- Diabetes remission is well-documented in high quality and long-term studies2- Diabetes resolution (complete remission) occurs in around 80% of cases3- Weight loss after bariatric surgery is huge and sustainable4- Bariatric surgery is far more superior than Intensive lifestyle intervention5- Bariatric surgeries are safe6- Bariatric surgeries are cost-effective

Bariatric Surgery Versus Intensive Lifestyle Intervention

To Answer this Question you Need:1- RCT2- Good sample size3- BS versus ILI4- Long duration of intervention

Authors Year Study Design Duration

Intervention (n) Control (n) Study Quality

1‐ Sjöström et al. (SOS)

2004 Case‐Control 10 LAGB (376156)VBG (1369451)RYGB (26534)

CT (2037627) Very Poor ‐ Not Randomized‐ Significant drop‐out‐ 68% of cases are VBG (obsolete surgery)

2‐ Dixon et al. 2008 RCT 2 LAGB (30) CT (30) Poor ‐ Versus conventional therapy and not ILI

3‐ Liang et al. 2013 RCT 1 RYGB (31) CT (36)CT+Exenatide (34)

Poor ‐ Versus conventional therapy and not ILI

4‐Wentworth et al. 2014 RCT 2 LAGB (25) CT (26) Poor ‐ Versus conventional therapy and not ILI

5‐ Courcoulas et al. 2015 RCT 3 RYGB+LLLI (21)LAGB+LLLI (20)

ILI (year 1) (20) Poor ‐ Small number‐ ILI with surgery

6‐ Ikramuddin et al. 2015 RCT 2 RYGB+ILS (60) ILI (60) Poor ‐ ILI with surgery

7‐ Ding et al. 2015 RCT 1 LAGB (23) ILI (22) Why WAIT Moderate ‐ Small number

8‐Mingrone et al. 2015 RCT 5 RYGB (20)BPD (20)

CT (20) Poor ‐ Small number‐ Versus conventional therapy and not ILI

9‐ Halperin et al. 2016 RCT 1 RYGB (19) ILI (19) Why WAIT Moderate ‐ Small number

CT=Conventional Therapy ILI=Intensive Lifestyle Intervention LLLI=Low‐level lifestyle Intervention VBG=Vertical Banded Gatroplasty BPD=Biliopancreatic Diversion

Major Bariatric Surgery Studies

10‐ Schauer et al. 2017 RCT 3 RYGB+ILS (50)Sleeve G+ILS (50)

ILI (50) Poor ‐ ILI with surgery

Definition of Remission from T2DM

0 0.01 0.02 0.03 0.04 0.05 0.06 0.07 0.08

Schauer P. 2017

Halperin F. 2016

Ikramuddin S. 2016

Mingrone G. 2015

Courcoulas A. 2015

Ding S. 2015

Wentworth J. 2014

Liang Z. 2013

Dixon J. 2008

Sjöström L. 2004

ADA

Definition of Remission by A1C

Complete remission

Partial remission

Any remission

With or without medications*

* Partial Remission: A1C <6.5 without medications for >yearComplete Remission: A1C <5.7 without medications for >year

Definition of Remission from T2DM

0 20 40 60 80 100 120 140

Schauer P. 2017

Halperin F. 2016

Ikramuddin S. 2016

Mingrone G. 2015

Courcoulas A. 2015

Ding S. 2015

Wentworth J. 2014

Liang Z. 2013

Dixon J. 2008

Sjöström L. 2004

ADA

FPG mg/dL

Definition of Remissin by FPG

Complete remission

Partial remission

Any remission

* Partial Remission: FPG 100‐126 mg/dl without medications for >yearComplete Remission: FPG <100 mg/dl without medications for >year

With or without medications*

Who Had the Surgery? and How Much Weight Loss?

Baseline

Baseline

Baseline

BaselineBaseline

2 year

1 years

1 year

1 year 1 year

10 years

5 years

3 years

5 years5 years

0

20

40

60

80

100

120

140

Sjöström L. 2004(whole surgerygroup reported)

Courcoulas A. 2015 Mingrone G. 2015 Ikramuddin S. 2016 Schauer P. 2017

Weight in kg before and after gastric bypass

Baseline weight

Weight at 1‐2 years

Weight at latest report

100 Kg

Average Weight Loss in 3‐10 years is 20‐25 Kg

Any Remission from T2DM at 3‐5 Years

1 yearn=342

1 yearn=99

1 yearn=41

2 yearsn=38

1 yearn=573 years

n=118

3 yearsn=97

3 yearsn=38

5 yearsn=38

5 yearsn=53

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Sjöström L. 2004 Courcoulas A. 2015 Mingrone G. 2015 Ikramuddin S. 2016 Schauer P. 2017

Remission, %of patients in surgical group

Any initial remission from T2DM

Any remission at latest report

FPG<126 mg/dL A1C<6.5 A1C<6.5 A1C<6.5 A1C<6%

Any Remission at 3 years 29‐37% Definitely not 75‐85%

Partial and Complete Remission from T2DM at 3 Years

1 year

1 year

2 years

2 years3 years

3 years

3 years3 years

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

Courcoulas A. 2015 partialremission

Courcoulas A. 2015 completeremission

Ikramuddin S. 2015 partialremission

Ikramuddin S. 2015 completeremission

Studies ≥ 3‐Year Follow‐up with Separate Definitions of Partial and Complete Remission

Partial Remission A1C <6.5%Complete Remission A1C <5.7%

Partial Remission A1C <6.5%Complete Remission A1C <6.0%

Partial Remission at 3 years 19‐25%Complete Remission at 3 years 10‐17% Definitely not 75‐85%

The results are not what’s most important, but how I present them after they’re twisted..!!

10%

85%

Impact of Bariatric Surgery on Healthcare Utilization & Costs in Patients with DM over 6 Years

Odds of Hospitalization Ratio of Counts of PCP Visits

Ratio of Counts of Specialist

ConclusionIn the six years following bariatric surgery, individuals with type 2 diabetes did not have lower healthcare costs than before surgery.

Bleich SN et al. Med Care. 2012, 50(1):58‐65

7,806 patients with diabetes who received bariatric surgery

Effective Non-Surgical Alternatives to $$$ Procedures

1- Structured Multidisciplinary lifestyle intervention2- Very low calorie diet2- Very low carbohydrates diet

+Anti-obesity medicationsDiabetes medications with weight loss action




Structured Multidisciplinary ILI

Why WAIT

Why WAIT ProgramLook AHEAD Study

Structure of Look AHEAD Versus Why WAIT

Wadden TA et al. Obesity. 2009;17:713–722.Hamdy O et al. Curr Diab Rep. 2008;8:413-420.

Dietary Intake:1200–1500 kcal/day < 250 lb1500–1800 kcal/day > 250 lb

Calorie Replacements:(2 liquid meal + one snack bar)Transition at week 20Menu plans provided

Physical Activity:Gradual increasesGoal of 175 min/wk10,000 steps

Medication Changes: PCP

Dietary Intake:1500 kcal/day for women1800 kcal/day for men

Calorie Replacements:(2 liquid meal + 2 snacks food)Transition at week 6Menu plans provided

Physical Activity:Gradual increasesGoal of 300 min/wk averageBalanced exercise (more resistance exercises)

Medication Change: Endocrinologist

StructuredMeal Plan

Calorie

Distribution

• 40‐45% from

carbohydrates

• 30‐35% from fat with

<10% from saturated fat

• 1‐1.5 gm/kg of body

weight from protein

• 14g fiber/1000 Kcal

2

SnackLists

Dinner MenusDiabetes‐Specific

Nutrition Formula

1‐3 times/day to replace

equivalent calories

Includes 100

and 200

calorie

snacks

17 choices with

detailed ingredients,

cooking instructions

and nutrition facts

Balanced Exercise Model

Flexibility Strength

Strength exercise is particularly important during weight reduction

Aerobic

Walking

Swimming

Biking

Dancing

Resistance tubing

Weight lifting

Yoga

Stretching

Yoga

Diabetes Medications and Body Weight

Weight Gain Weight Neutral Weight Loss

Significant Modest

Pioglitazone

SUsGlyburideGlipizide

InsulinNPHGlargineRegularAspartLisproGlulisine

SUsGlimepirideGlipizide XL

GlinidesRepaglinideNateglinide

InsulinDetemirGlulisine (PP)

Metformin

DPP‐4 InhibitorsSitagliptinSaxaglipitinLinagliptinAlogliptin

‐glucosidase InhibitorsAcarboseMiglitol

Colesevelam

Bromocriptine

GLP‐1 AnalogesExenatideLixisenatideExenatide ERLiraglutideDulaglutideAlbiglutide

Pramlintide

SGLT2‐InhibitorCanagliflozin

DapagliflozinEmpagliflozin

Stop, Reduce or Switch Continue Add

1‐ Identify

2‐ Plan

3‐ Change

List A List B

‐16.0

‐14.0

‐12.0

‐10.0

‐8.0

‐6.0

‐4.0

‐2.0

0.0

0 3M 6M 9M 12M 15M 18M 21M 24M 27M 30M 33M 36M 39M 42M 45M 48M 51M 54M 57M 60M

***

*** ***

***

******

*** *** *** *** *** *** *** *** *** *** *** ***

Weight Loss (%)

Duration in Months

Total Group n=129Group 1 n=61 (Participants maintained <7% weight loss at 1 year)Group 2 n=68 (Participants maintained > 7% weight loss at 1 year)

*** p<0.001 (group 1 vs. group 2)

*** ***

‐9.0%

‐3.5%

‐6.4%

Percentage Weight Reduction in Patients with Diabetes in the Real‐World Clinical Practice over 5 years (Joslin Why WAIT Program)

21% Stopped insulin50-60% Reduction in Medications

BMJ Open Diabetes Res Care. 2017;5(1):e000259

3 9 15 21 27 33 39 45 51 57 63-10

-5

0

5

10

15

20

25

30

35

Percenatge change of eGFR and Creatinine over 63 months

Months

Creatinine

eGFR

Percentage of patients who achieved major glycemic improvement, partial or complete remission after 1 year of OILI

Mottalib et al. J Diabetes Res. 2015;2015:468704

Effect of Weight Reduction on QOL

Halperin F et al. JAMA Surg. 2014;149(7):716‐26.




Weight Loss and Glucostatic Parameters Before and After RYGB and VLCD

Jackness C et al. Diabetes. 2013;62(9):3027-32

Relationship Between Insulin Sensitivity and Insulin Secretion Before and After Interventions

Jackness C et al. Diabetes. 2013;62(9):3027-32

Date Carbs Protein Fat Calories Description

1152 B.C. High Low Low Wheat grains, grapes, honey, berries3,4

150‐200 A.D. High Low Low Fruits, sweet wine3,4

1797‐early 19th century

Low High High

No plant products except a small amount of wheat flourBreakfast: 1 1/2 pts milk, 1/2 pt lime water, bread and butter.

Noon: Plain bread pudding (blood and suet only). Dinner: fat and rancid old meat and game. Supper: like breakfast4

1864 High Low Low Diluted milk, occasionally boiled with white bread/barley4

End of 19th century

43% 18% 39%<800–1,000

Rice, oatmeal, potato, legume, or porridge diets (or "cures," as they were commonly called)4

Modified from Wheeler ML. Diabetes Spectrum 13(3):116, 2000.1Marcus Aurelius Antoninus, 2nd century A.D. 9th ed. Bartlett J, ed. Boston, Little, Brown and Co., 1901. 2Post E. New York, Funk & Wagnalls, 1922. 3Wood FC, Bierman EL. Nutr Today 7(3):4-12, 1972. 4Leeds AR. Proc Nutr Soc 38:365-71, 1979. 5Allen FM. Boston Med Surg J 172:241-47, 1915. 6Joslin EP J. Am Diet Assoc 3:89-92, 1927. 7Joslin EP et al. 7th ed. Philadelphia, Lea & Febiger, 1940, p. 212. 8Caso EK J /Am Med Assoc 133:169-71, 1947. 9Caso EK J. Am Diet Assoc26:575-83, 1950. 10American Diabetes Association. Diabetes 20:633-34, 1971. 11American Diabetes Association. Diabetes 28:1027-30, 1979. 12American Diabetes Association. Diabetes Care 10:126-32, 1987. 13American Diabetes Association. Diabetes Care 23 (Suppl. 1):43-46, 2000.

History of Diabetes Nutrition


1940 38% 17% 45% Normal1,600 cal/day=3 slices whole wheat bread, saucer of cereal, 3 oranges, 4 portions of 5% vegetables,a

1/4 pt milk, 1/4 pt cream, 1 egg, 2 moderate portions of meat, 1 oz butter7

1950 43% 19% 37% Normal

1,700 cal/day=1 pt whole milk, A vegetablesb as desired,

1B vegetable serving,c 3 fruit servings, 8 bread servings, 7 meat servings, 3 fat servings. Note: Serving = exchanges8,9

1971 45% or more American Diabetes Association10



Diabetes Care 1991;14 (Supplment 2):20-27

National Recommendations and Principles for Individuals with Diabetes Mellitus


1979 50‐60% 12‐20%<10% as saturated fat

American Diabetes Association11

1986 55–60% 0.8g/kg total fat <30% American Diabetes Association12

1994 10–20%<10% from saturated fat

American Diabetes Association13






The High Fat Era (Michigan Diet)(Use of a High Fat Diet in the Treatment of Diabetes)

Diabetes Mellitus

Newburgh LH, Marsh PL. Arch Inter Med. 1920; 26: 647.

Further additions up to 2,500 calories may be made to suit individual cases

Maintain nitrogen balance by 0.66 gm/kg

Calories Fat Carbohydrates Protein

900‐1000 90 gm 10 gm 14 gm

1400 170 gm 25‐30 gm 30‐40 gm

Avoid the danger of:• Inadequate energy• Excess Carbohydrates• Excess protein

Newburgh LH, Marsh PL. Arch Inter Med. 1920; 26: 647.

73 cases in 1920: 4 died from unrelated reasons

45 cases in 1921: (blood glucose 60-130 mg/dL)

The High Fat Era (Michigan Diet)(Use of a High Fat Diet in the Treatment of Diabetes)

Diabetes Mellitus

“Strict diet”: Meats, poultry, game, fish, clear soups, gelatin, eggs, butter, olive oil, coffee, tea

Osler W & McCrae T, The Principles and Practice of Medicine, 1923; Westman EC, Perspect Biol Med, 2006

Joslin Diabetes Diet, 1923Quantity of food required by severe diabetic patient weighing 60 Kg

Food Calories (%)

Protein 75 g 300 (17%)

Fat 150 g 1350 (75%)

Carbohydrate 10 g 40 (2%)

Alcohol 15 g 105 (6%)

1795

An Online Intervention: Very Low‐Carbohydrate Diet Versus a Plate Method Diet in Overweight Individuals with Type 2 Diabetes: A Randomized Controlled Trial

‐0.3% ‐0.8% ‐3.0 Kg ‐12.7 Kg

Saslow LR et. JMIR 2017; 19:2 (Feb 13, 2017)

8 Keys to Optimal Lifestyle Intervention for Long‐term Weight Reduction

1. Aim for meaningful weight loss goal (5‐10%)

2. Gradual, balanced and individualized physical activity A. Duration of exercise

B. Type of exercise

C. Exercise records

3. Structured dietary intervention & modified macronutrient composition

A. Relatively higher protein, LGI & higher fibers

B. Provided menus

C. Food records

D. Diabetes specific meal replacement

4. Medication adjustment and frequent BG monitoring

5. Counseling and cognitive behavioral change

6. Group intervention and frequent participant contact

7. Daily weighing

8. Online and mobile interaction and support

Economic Impact of Non‐Surgical Weight Loss over One Year in Patients With Diabetes

Cost Saving(1% wt loss)

Cost saving per year

(‐3.6%)1*(‐5.8%)2*

(‐27%)

(‐44%)

Estimated Saving with(7% wt loss)

YU AP et al. Curr Med Res Opin. 2007;23(9):2157‐69

Health Care Cost Diabetes Related Cost

1. p<0.05 2. p<0.001

Take Home Message

Remission from type 2 diabetes after bariatric surgery is overstated

Bariatric studies are misleading, poorly designed, of short duration or include very small sample size

Bariatric surgeries are not cost effective over 6 years

Diabetes remission occurs with low‐calorie diet, low‐carbohydrates diet or with structured lifestyle intervention

Non‐surgical intervention improves patients' quality of life in comparison to bariatric surgeries

Referring patients with diabetes to bariatric surgery should be limited to severe cases of obesity

Endocrinologist should not be fooled by bariatric propaganda!

Thank You

Complications after bariatric surgery• Gastric erosion (LAGB)

• Postprandial symptoms: heartburn/GERD, dysphagia, epigastric pain

• Surgical complications: • Bleeding• Anastomosis leakage• Obstruction• Wound infection • Abscess formation• Pulmonary complications• Incisional hernia

• Nutrient deficiency, biochemical abnormalities• Iron• Folate• Thiamine• Vitamin D• B12 (gastric bypass)

% weight loss after gastric bypass compared to baseline

2 year

1 years1 year

1 years

1 year10 years 3 years 3 years

5 years

3 years

0%

5%

10%

15%

20%

25%

30%

35%

40%

Sjöström L.2004

Schauer P.2014

CourcoulasA. 2015

Mingrone G.2015

IkramuddinS. 2016

% weight loss compared to baseline

Weight loss in % after gastric bypass surgery

Weight loss at first report

Weight loss maintained at latestreport

Name Typeofstudy

Duration(years)

Intervention Patientsno.

Sjöströmetal.SOSinterventionstudy2004

Prospectivematched

2‐10 NAGBor(L)AGB

376(15610yearfollowup)

VGB


GBP


Nonsurgicaltreatmentgroup,nostandardizedintervention

2037(627 10yearfollowup)

Dixonetal. AdjustableGastricBandingandConventionalTherapyforType2Diabetes2008

RCT 2 Conventionaldiabetestherapy 30

LAGB+conventionaldiabetescare 30

Liangetal.EffectoflaparoscopicRoux‐en‐Ygastricbypasssurgeryontype2diabetesmellituswithhypertension:Arandomizedcontrolledtrial2013

RCT

1

Usualcare

36

Usualcare+Exenatide

34

RYGB 31

Wentworthetal.Multidisciplinarydiabetescarewithandwithoutbariatricsurgeryinoverweightpeople:arandomizedcontrolledtrial2014

RCT 2 LABG+multidisciplinarydiabetescare

25

Multidisciplinarydiabetescare 26

Schaueretal.BariatricSurgeryversusIntensiveMedicalTherapyforDiabetes–3‐YearOutcomes2014

RCT

3 Roux‐en‐Y+intensivemedicaltherapy 50Sleevegasterectomy+intensivemedicaltherapy

50

Intensivemedicaltherapy 50Courcoulasetal.ThreeYearOutcomesofBariatricSurgeryvs.LifestyleInterventionforType2DiabetesMellitusTreatment:ARandomizedControlledTrial2015

RCT 3 Intensivelifestyleweightlossinterventionforoneyearfollowedbylowelifestyleweightlossintervention(LLLI)fortwoyears

20

RYGB+LLLIinyears2and3 20

LAGB+LLLIinyears2and3 21

Ikramuddinetal.Roux‐en‐Ygastricbypassfordiabetes(theDiabetesSurgeryStudy)2‐yearoutcomeofa5‐year,randomized,controlledtrial2015

RCT 2 Intensivelifestyleandmedicalmanagement

60

RYGB+lifestyleandmedicalmanagement

60

Dingetal.AdjustableGastricBandSurgeryorMedicalManagementinPatientsWithType2Diabetes:ArandomizedControlledTrial

RCT

1

IMWM,IntensiveMedicalandWeightManagement(WhyWAIT)

22

LAGB

23

Documents

Debate: What’s the Best Way to Treat Obesity in Type 2 ......... What’s the Best Way to Treat Obesity in Type 2 Diabetes? Lee M. Kaplan, MD, ... The key to optimizing clinical