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Diabetes Weight Management in Clinical Practice: Why WAIT Program Osama Hamdy, MD, PhD, FACE Medical Director, Obesity Clinical Program, Joslin Diabetes Center, Harvard Medical School

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Diabetes Weight Management in Clinical Practice:Why WAIT Program

Osama Hamdy, MD, PhD, FACE

Medical Director, Obesity Clinical Program,Joslin Diabetes Center,Harvard Medical School

Weight control in diabetes practice is the most frustrating challenge

second to HbA1c!

Weight control in diabetes practice is the most frustrating challenge

second to HbA1c!

40.1

35.8

19.3

2.72.1

Underweight Normal Weight Overweight Obese Extremely Obese

Department of Health and Human Services,Center for Financing, Access, and Cost Trends, AHEQ

0.720.3

33

36.5

9.5

Percentage Distribution of Diabetic and Nondiabetic Adults in the U.S. PopulationPercentage Distribution of Diabetic and Nondiabetic Adults in the U.S. Population

NonNon--Diabetic Adults Diabetic Adults Diabetic Adults Diabetic Adults

Normal Weight Normal Weight

-1

0

1

2

3

4

5

6

7

8

MetforminMetformin

Diet aloneDiet alone

SulfonylureasSulfonylureas

InsulinInsulin

Wei

ght C

hang

e (K

g)W

eigh

t Cha

nge

(Kg)

Years After RandomizationYears After Randomization

UKPDS Lancet 1998;352:854-856

108642

Change in Body Weight With Diabetes Medications Change in Body Weight With Diabetes Medications

-7.1 -7.4-3.3

56.8

-20

0

20

40

60

*Weight BMI W/H Si

Perc

enta

ge (%

) Cha

nge

Body Weight % Body Weight Waist / Hip

Insulin Sensitivity

Hamdy O et al Diabetes Care 2003;26:2119-2125

* *

*

* p <0.001

Benefits of ShortBenefits of Short -- term Weight Reduction term Weight Reduction on IS in Type 2 DM and in Preon IS in Type 2 DM and in Pre-- diabetes diabetes

It is difficult to implement in routine clinical practice

It is costly for patients

Who will pay for it?

It is unsustainable

It is impossible to get similar results

It is difficult to implement in routine clinical practice

It is costly for patients

Who will pay for it?

It is unsustainable

It is impossible to get similar results

Common Criticisms to Clinical Research Around Weight Management in Diabetes

Joslin Comprehensive Program Joslin Comprehensive Program for Diabetes Weight Management for Diabetes Weight Management

Components of the Why WAIT?

• Interactive-Intensive Diabetes Treatment• Structured Modified Dietary Intervention• Graded-Balanced & Individualized Exercise Plan• Cognitive Behavioral Support• Group Adult-Educational Sessions

Modifications of Diabetes Medications

Potential Weight Gain Diabetes Medications

Most InsulinsNPH & Regular GlargineLisproAspart

Sulfonylureas GlyburideGlipizideGlimepiride

GlinidesNateglinideRepaglinide

TZDsPioglitazone (Actos)Rosiglitazone (Avandia)

Weight Neutral or Potential Weight LossDiabetes Medications

Metfomin Pramlintide (Symlin)Exenatide (Byetta)Glulisine insulin (Apidra) PPDetemir insulin (Levemir)DPP-IV inhibitors

Sitagliptin (Januvia)

Obesity Medications

Orlistat (Xenical)Sibutramine (Meredia)

Future Medications

Endocannabinoid RB DPP-IV inhibitors

VildagliptinGLP-1 Analogues

LiraglutideGLP-1R Agonists

Exenatide LAR

List A List B

Joslin New Nutrition GuidelinesJoslin New Nutrition Guidelines

Reduce Daily Caloric Intake by 250-500 cal~ 40% Carbohydrates, LGI, High Fiber20-30% Protein30% Fat (no TF, 7-10% SF, 20% Mono & Poly UF)Allowed Meal Replacement, Same Diet Composition

Reduce Daily Caloric Intake by 250-500 cal~ 40% Carbohydrates, LGI, High Fiber20-30% Protein30% Fat (no TF, 7-10% SF, 20% Mono & Poly UF)Allowed Meal Replacement, Same Diet Composition

www.joslin.orgwww.joslin.org

Structured Modified Dietary Intervention

2 Meal Replacements (BOOST® Diabetic or BOOST®

Glucose Control™ )

Two 100 cal snacks (e.g. Fruit, Nuts)

Choice from 15 pre-set dinner menus

60135701800501126015004090501200

FatProteinCarbs

Structured Modified Dietary Intervention

Meal Plan Dinner Composition

Graded

Balanced

Individualized

Obese, sedentary, limited ROM

Aerobic, resistance & stretching Ex

Based on clinical & exercise history

Graded-Balanced & Individualized Exercise Plan

Graded-Balanced & Individualized Exercise Plan

AEX+STCH+ CT + IT

50-60 min6 days /wk9-12

AEX+STCH+ CT

40-45 min5 days /wk5-8

AEX+STCH20-40 min4 days /wk1-4

Type of Exercise

Duration of Exercise

Frequency of Exercise*

Session Number

30-60 minute sessions facilitated by psychologist

Realistic and attainable goals (Smart Goals) for long-term sustainability

Relapse prevention using Logbook Learning and success stories

Mastering unique challenges (Delay and distraction, Planning ahead, Problem solving)

Managing automatic, negative thoughts (“detour thinking”)

Cognitive Behavioral Support

Group Adult-Educational Sessions“Let Us Start” All Team

“Balancing the Calorie Scale” RD“When Thoughts Get in Your Way” Psychologist “Take Action-Be Active” EP“Effect of Lifestyle on Diabetes & Vascular Health” MD“Making Sense of Portion Distortion” RD“Burn the Fat” EP“Lapse, Relapse, Collapse” Psychologist“Stay Active-Keep it Off” EP“Lifestyle and Food: What Science Says” MD“Keeping out of the Fast Food Lane” RD

“Eating for Life: How to Put it All Together” All Team

Why WAIT ResultsWhy WAIT Results

22/40M/F

138.2TG mg/dL100.8LDL-C mg/dL41.1HDL -C mg/dL

6.1CRP mg/L

165.8TC mg/dL

7.3HbA1c %7.2 (0-22)Duration of Diabetes yrs

56.1 (33-77)Age Average (range) yrs

Why WAIT? Program: Demographic & Baseline Data

Hamdy O et al, ADA 2007

239.5Weight Average (range) lbs38.4BMI Average (range) kg/m2

43.5% Body Fat

1877BMR Kcal/day

47.0Waist (inch)

Why WAIT? Program: Baseline Body Composition

Hamdy O et al, ADA 2007

-4.44

-7.01-9.27

-11.2

-13.7-15.44

-16.97

-19.48-20.34-22.15

-24.47-25

-21

-17

-13

-9

-5

-1

Wei

ght L

oss

in L

bs

Hamdy O et al, ADA 2007

Than

ksgi

ving

Than

ksgi

ving

Change in Body Weight During Why WAIT? Program (group 1)

Week 1-12

n = 14

-8.1-10.8

-12.9-15

-17-19.2

-20.8-23.3

-23.5-26.5 -25.45

-20.7

-28

-24

-20

-16

-12

-8

-4

0

Wei

ght L

oss

in L

bsChange in Body Weight During Why WAIT? Program (group 2)

Week 1-12

Hamdy O et al, ADA 2007n = 13

-5.12-7.64

-9.53-12.01

-14.19-16.44

-18.12

-21.61

-24.16-24.78-26.57

-19.61

-27

-23

-19

-15

-11

-7

-3

Wei

ght L

oss

in L

bs

n = 14

Change in Body Weight During Why WAIT? Program (group 3)

Week 1-12

Hamdy O et al, ADA 2007

-3.59

-6.09-7.54

-9.79 -10.5-12.38

-14.71 -14.62-15.29

-17.29-17.98

-13.69

-20

-16

-12

-8

-4

0

Wei

ght L

oss

in L

bs

n = 11

Change in Body Weight During Why WAIT? Program (group 4)

Week 1-12

Hamdy O et al, ADA 2007

-5.59

-8.26 -9.09-10.53

-12.78-14.82

-16.04

-22.6-21.18

-22.54-19.58

-18.06

-25

-21

-17

-13

-9

-5

-1

Wei

ght L

oss

in L

bs

n = 14

Change in Body Weight During Why WAIT? Program (group 5)

Week 1-12

-7.02-9.18

-11.13-12.78

-15.49-16.66

-18.64

-24.35-22.73

-26.05

-23.08

-20.05

-27

-23

-19

-15

-11

-7

-3

Wei

ght L

oss

in L

bs

n = 13

Change in Body Weight During Why WAIT? Program (group 6)

Week 1-12

Hamdy O et al, ADA 2007

-5.3

-8.1-9.7

-11.7-13.5

-15.6-17.4

-20 -20.8-22.7 -23.5

-18.1

-25

-21

-17

-13

-9

-5

-1

Wei

ght L

oss

in L

bsChange in Body Weight During Why WAIT? Program

Week 1-12

Hamdy O et al, ADA 2007n = 62

-5.3

-2.8

-1.8 -2 -2.2 -2.1

-1.5 -1.7 -1.5 -1.4 -1.5-1.2

-6

-5

-4

-3

-2

-1

0

Wei

ght L

oss

in L

bsChange in Body Weight During Why WAIT? Program

Week 1-12

Hamdy O et al, ADA 2007n = 62

-9.8-12

-10

-8

-6

-4

-2

0237.5

214.3

150

170

190

210

230

250

Bod

y w

eigh

t in

lbs

n = 62 * p <0.05 ** p <0.01 *** p <0.001

Changes in Body Weight after Why WAIT? Program

Body Weight % Weight Change

***

-23.5 lb

% C

hang

e

***Hamdy O et al, ADA 2007

38.3

35

25

30

35

40

n = 62 * p <0.05 ** p <0.01 *** p <0.001

Changes in BMI after Why WAIT? Program

***B

MI i

n K

g/m

2

Hamdy O et al, ADA 2007

7.3

6.4

5

6

7

8

Changes in HbA1cafter Why WAIT? Program

***

HbA

1c (%

)

n = 62 * p <0.05 ** p <0.01 *** p <0.001 Hamdy O et al, 2007

-0.89-1

-0.8

-0.6

-0.4

-0.2

0

Ave

rage

HbA

1c C

hang

e

***

47.2

43.4

35

40

45

50

Wais

t in

inches

Changes in Waist and Waist/Hip Ratioafter Why WAIT? Program

***

-3.7 inches

0.94

0.92

0.8

0.9

1

Waist Waist/Hip Ratio

**

n = 62 * p <0.05 ** p <0.01 *** p <0.001 Hamdy O et al, ADA 2007

101.6

85.8

75

80

85

90

95

100

105

110

Changes in %Body Fat, Fat Mass & Lean/Fat Ratio after Why WAIT? Program

43.23

39.95

3536373839404142434445

Bod

y Fa

t Mas

s in

lbs

Fat Mass (lbs) Body Fat (%) Lean/Fat Ratio

1.5

1.57

1.4

1.45

1.5

1.55

1.6

***

***

n = 62 * p <0.05 ** p <0.01 *** p <0.001

*

Hamdy O et al, ADA 2007

165.8

138.2

100.8

41.1

144.1

99.186

39.5

020406080

100120140160180200

***

mg/

dL

******

TC Triglycerides LDL HDL n = 62

* p <0.05 ** p <0.01 *** p <0.001

*

Changes in Lipid Profile after Why WAIT? Program

Hamdy O et al, ADA 2007

-12.2

-21.8

-11.4

-3

-30

-25

-20

-15

-10

-5

0

% C

hang

ePercentage Changes in Lipid Profile after Why WAIT? Program

TC Triglycerides LDL HDL n = 62 * p <0.05 ** p <0.01 *** p <0.001 Hamdy O et al, ADA 2007

125.4

105.3

0

20

40

60

80

100

120

140

mg/

dLChanges in Non-HDL and TC/HDL Ratio after Why WAIT? Program

Non HDL-Cholesterol TC/HDL

4.13.7

0

1

2

3

4

5

Rat

io

n = 62 * p <0.05 ** p <0.01 *** p <0.001

*** ***

Hamdy O et al, ADA 2007

0.92 0.9

0

0.2

0.4

0.6

0.8

1

1.2

mg/

dLChanges in Kidney Functions after Why WAIT? Program

S. Creatinine BUN

17 17.1

5

10

15

20

Mg/

dL

n = 62 * p <0.05 ** p <0.01 *** p <0.001 Hamdy O et al, ADA 2007

n = 62 * p <0.05

29.4

20.16

0

10

20

30U

rinar

y A

lbum

in/c

reat

inin

e R

atio

m

cg/m

g

Changes in Urinary Albumin/Creatinine Ratio after Why WAIT? Program

**

Hamdy O et al, ADA 2007

24.1

21.98

5

10

15

20

25

30

IU/L

Changes in Liver Enzymes after Why WAIT? Program

AST ALT

27.9

21.7

5

10

15

20

25

30

***

IU/L

**

n = 62 * p <0.05 ** p <0.01 *** p <0.001 Hamdy O et al, ADA 2007

Changes in CRPafter Why WAIT? Program

6

4.2

3

4

5

6

7

**

CR

P in

mg/

L

n = 62 * p <0.05 ** p <0.01 *** p <0.001 Hamdy O et al, ADA 2007

Changes in Adiponectinafter 6 Months of the Why WAIT? Program

6.7

11.6

0

2

4

6

8

10

12

14 **A

dipo

nect

in in

g/

ml

n = 15 * p <0.05 ** p <0.01 *** p <0.001 Hamdy O et al, ADA 2007

Changes in TNF-after 6 Months of the Why WAIT? Program

3.99

2.96

2

3

4

5

*

TNF-

in p

g/m

l

n = 15 * p <0.05 ** p <0.01 *** p <0.001 Hamdy O et al, ADA 2007

226.9

178.5

100

150

200

250

sIC

AM

in n

g/m

lChanges in sICAM and sVCAMafter 6 Months of the Why WAIT? Program

sICAM sVCAM

796.9

655.7

400

600

800

1000

**sV

CA

Min

ng/

ml

*

n = 15* p <0.05 ** p <0.01 *** p <0.001 Hamdy O et al, ADA 2007

Changes in E-Selectinafter 6 Months of the Why WAIT? Program

28.8

20.2

0

5

10

15

20

25

30

35

*

E-Se

lect

inin

ng/

ml

n = 15 * p <0.05 ** p <0.01 *** p <0.001 Hamdy O et al, ADA 2007

Is Weight loss sustainable?Is Weight loss sustainable?

Results of Why WAIT? Program Follow up of the 5 groups

Hamdy O et al, ADA 2007

-11.2

-16.97

-23.5 -23-25.1 -25.43 -25.23 -24.82 -24.5

-30

-25

-20

-15

-10

-5

00 1 2 3 4 5 6 7 8 9

Wei

ght c

hang

e in

lbs

from

bas

elin

e

Program End

Months of follow-up

450% (5%)11 (47.3 unit/d)2 (45 unit/d)Pramlintide-21% (-54%)11 (24.1 unit/day)14 (52.1 unit/d)Short acting Analog30% (-55%)13 (27.2 unit/day)10 (60.9 unit/d)Long acting Analog-50% (-12%)3 (41.7 unit/day)6 (47.5 unit/day)NPH

Insulin

213% (17)25 (17.6 mcg/d)8 (15 mcg/d)Exenatide

2% (12%)47 (1862 mg/d)46 (1664.1 mg/d)Metformin

-71% (-33%)2 (5 mg/d)7 (7.4 mg/d)Rosiglitazone-88% (-47%)1 (15 mg/d)8 (28.1 mg/d)Pioglitazone

Thiozelidindiones-63% (-41%)3 (6.6 mg/d)8 (11.25 mg/d)Glipizide-67% (-35%)2 (6.2 mg/d)6 (9.5 mg/d)Glyburide

Sulfonylureas

% Change# patients

(dose)

After# patients (dose/day)

Before# patients (dose/day)

Diabetes Medication

Change of Diabetes Medications

Cost Saving on Diabetes Medications

Per Month: $ 46.78

During the Program: $ 140.34

Estimated/year: $ 561.37

Hamdy O et al, ADA 2007

What is Unique About the WWP?

• The model of intervention is suitable for clinic use

• Components of the program are mostly covered by US insurance including Medicare

• Easily transferable to primary care setting• Potential for long-term positive results

• The model of intervention is suitable for clinic use

• Components of the program are mostly covered by US insurance including Medicare

• Easily transferable to primary care setting• Potential for long-term positive results

Thank YouThank You