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Learning Objectives

•  Assess the key findings of the McMaster meal replacement therapy (MRT) study

•  Identify patients with T2DM who are candidates for MRT

•  Develop a plan to implement partial MRT into a patient’s diet

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Agenda

•  Background •  Experience with MRT at McMaster •  Aims of our study •  Methods and protocol •  Results •  Case studies •  Practical tips •  Conclusions

Impact of Weight Loss on Risk Factors

~5% Weight loss

5%-10% Weight loss

A1C 1 1

Blood pressure 2 2

Total cholesterol 3 3

HDL cholesterol 3 3

Triglycerides 4

1. Wing RR, et al. Arch Intern Med 1987;147:1749-1753. 2. Mertens IL, Van Gaal LF. Obes Res 2000;8:270-278. 3. Blackburn G. Obes Res 1995:3(suppl 2):211S-216S. 4. Ditschunheit HH, et al. Eur J Clin Nutr 2002;56:264-270.

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The Challenge! Obesity: A Multifaceted Issue!

OBESITY

Food

Inactivity

Medications

Psychological factors

Genetics

Co-morbid conditions

Weight Loss – How?

•  Diet •  Low Carb •  High Protein •  Low Fat •  600 calorie diet •  Meal Replacements

•  Techniques •  Goal setting •  Group/Online support •  Calorie tracking •  Coaching

•  Other •  Pharmacology •  Bariatric Surgery

There is no one specific profile that will work for everyone!

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Meal Replacement Therapy

•  Partial meal replacement plans can result in: •  Weight loss •  Improvements in glycemic control •  Reductions in antihyperglycemic

medications

Dworatzek, Paula D, et al. Can J Diabetes 2013;37(suppl 1):S51.

The ILI* Group Program over the 4 Years

*Intensive Lifestyle Intervention Wadden TA, et al. Obesity 2009;17;713-22.

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Wadden, et al. 2009 Results

*Intensive Lifestyle Intervention Wadden TA, et al. Obesity 2009;17;713-22.

•ILI, Intensive Lifestyle Intervention

Wadden TA et al. One-year weight losses in the Look AHEAD study: factors associated with success. Obesity 2009:17;713–22.

Wadden et al. 2009Results

Results after one year:

Look AHEAD Study

Key assessments ILI*N=2570

Usual careN=2570

Wt, % change+ insulin- insulin

-7.6 ± 7-8.7 ± 6.9

-0.3 ± 5.1-0.8 ± 4.7

A1C, % -0.67 ± 0.02 0.14 ± 0.02Fasting glucose, mg/dL -21 ± 0.9 -7.2 ± 0.9TG, mg/dL -30 ± 2.0 -14.6 ± 1.8

Meal replacement

users

2

Weight, % change

Results after one year:

ILI:Intensive Lifestyle Intervention

Wadden TA et al. One-year weight losses in the Look AHEAD study: factors associated with success. Obesity 2009:17;713–22.

Wadden  et  al.  2009

Results

1st 2nd 3rd 4th

5.9%7.2%

9.4%

11.2%Quartile of meal replacement (MR)

Red

uctio

n in

initi

al w

eigh

t in

ILI p

artic

ipan

ts

Participants in the highest quartile of meal replacement use had• 4.0 times greater odds of reaching the 7% weight loss goal and • 4.1 times greater odds of reaching the 10% goal than did participants in the lowest quartile

117MRs 277

MRs406MRs

608MRs

2

Results after one year:

ILI:Intensive Lifestyle Intervention

Wadden TA et al. One-year weight losses in the Look AHEAD study: factors associated with success. Obesity 2009:17;713–22.

Wadden  et  al.  2009

Results

1st 2nd 3rd 4th

5.9%7.2%

9.4%

11.2%Quartile of meal replacement (MR)

Red

uctio

n in

initi

al w

eigh

t in

ILI p

artic

ipan

ts

Participants in the highest quartile of meal replacement use had• 4.0 times greater odds of reaching the 7% weight loss goal and • 4.1 times greater odds of reaching the 10% goal than did participants in the lowest quartile

117MRs 277

MRs406MRs

608MRs

2 *Intensive Lifestyle Intervention Wadden TA, et al. Obesity 2009;17;713-22.

Wadden, et al. 2009 Results

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Let’s Go Back to 2006.... McMaster DCRP* Experience •  Many patients struggling with traditional

approaches to weight loss •  Dietitians initiated novel approach of

MRT as standard of care to assist individuals with T2DM with weight loss

•  Recruited individuals from dietitians, physicians, and nurses

•  Data collection to monitor patient’s progress

•  Diabetes Care and Research Program, Hamilton Health Sciences

MRT Protocol

•  Instructed by RD to include 2 cans of Glucerna®* per day as part of a ~1,200 to 1,400 calorie diet �  *Each can of Glucerna® provided 230 kcal, 30 g

CHO (24 g available CHO), 11 g PRO, 8 g FAT �  CHO: 50-55%; PRO: 20%; FAT: <30% �  Alternative sample menus (30 g CHO meal and

15 g CHO snack ideas) were provided •  Glucerna® samples and coupons

were provided

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Glucerna®

•  Gluten-free •  Low lactose (less than 0.5 g per serving) •  Low glycemic index (26) •  Fructo-oligosaccharides

•  Natural CHO that aren’t digested in GI tract (fibre)1

•  Fermented by bifidobacteria in the colon to SCFA*, which are an energy source in the colon

•  Provide food to beneficial bacteria in the colon

1Health Canada. List of dietary fibres reviewed and accepted by Health Canada’s Food Directorate. 2013. http://www.gftc.ca/pdfs/2-listofdietaryfibresreviewedandacceptedbyhealthcanada_dec%202013.pdf (accessed May 1, 2014). *Short Chain Fatty Acids

Normal Digestion and Absorption (Sucrose, glucose, and starches)

Slow Digestion and Absorption (Fibersol + FOS)

Source: http://glucerna.ca/english/TheGlucernaScience-Drinks.html.

Science Behind Glucerna®

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Comparison of Diabetes Nutritional Drink Products

Glucerna® 250 mL

can

Glucerna®237 mL bottle

Calories 230 225

Protein (g) 11.4 11.3

Fat (g) 8.3 8.2

Carbohydrate (g) 30.4 26.7

Available CHO (g) 24.0 23.0

* p< 0.001

Adjusted Mean Change in Plasma Glucose over Time

J.A. Williams, J. Garcia Almeida, M. Matia Martin, et al. Lack of Glycemic Response at 120 minutes post prandial with a New Diabetes Specific Nutritional Formula (Abstract). Clinical Nutrition Supplements Sept 2009;4(S2):LB003.

Original Glucerna Glucerna  bo,le  

66%  lower    than  the  standard  

nutri5onal    formula  

*

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Protocol – Sample Day

Breakfast 1 can Glucerna®* +/- morning snack� 0 to 30 g of lean protein 175 mL no sugar added yogurt or fruit

Lunch 1 can Glucerna®* +/- afternoon snack� 30 to 60 g of lean protein 250 to 500 mL free vegetables (raw/cooked/soup/salad) 2 fat choices 175 mL no sugar added yogurt or fruit

Supper ! 2 to 3 starch choices +/- evening snack� 60 to 120 g lean protein 500 mL free vegetables (raw/cooked/soup/salad) 2 fat choices 250 mL 1% milk or 175 mL diet pudding/yogurt or fruit

* = Or equivalent meal replacement product with similar nutritional content � = Water/tea/coffee/diet beverage !  = Based on Canadian Diabetes Association’s “Plate Method”

Protocol (cont’d)

•  General physical activity guidelines •  Regular telephone contact •  Frequent visits with Registered

Dietitian •  Blood glucose (BG) testing QID

upon initiating •  Adjusted diabetes medications

to prevent hypoglycemia

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“The effect of partial MRT on weight loss and glycemic control: a retrospective review”

Aims of the study: •  Examine weight •  Examine glycemic control •  Examine diabetes treatment changes •  Examine adherence

Methods

•  Retrospective cohort study (2006 to 2008)

•  Inclusion criteria: •  T2DM •  Used partial meal replacement for

at least 3 months •  Not participating in other

research studies (i.e. ACCORD)

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Results – Baseline Characteristics Characteristics (N=47) Mean ± SD Male:Female ratio 20:27

Age (years) 60 ± 8.8

Weight (kg) 115.4 ± 22.4

Body Mass Index (kg/m2) 40 ± 6.4

A1C (%) 7.6 ± 1.5 %

Diabetes Treatment (%) - Diet only - Oral Agents only - Insulin only - Insulin + Oral Agents

4.3 %

29.8 % 25.5 % 40.4 %

Insulin Total Daily Dose (units) 156 ± 95

Results – Weight Change

-10

-8

-6

-4

-2

0

3 months6 months

Compared to baseline, * = p<0.01

kg

-­‐   3.4  kg              *  

-­‐   6.1  kg              *  

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Results – Glycemic Control

A1C

(%)

6

6.5

7

7.5

8

0 3 6

Number of months Compared to baseline, * = p<0.01; † = p<0.05

*  †  

Results – Insulin TDD Change

% In

sulin

TD

D C

hang

e

-30

-25

-20

-15

-10

-5

0

3 months6 months

Compared to baseline, * = p<0.01

-­‐   17  %              *  

-­‐ 24  %              *  

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Results – Adherence and Attrition

•  34% dropout rate •  Mean dropout time: 9.7 ± 3.7 months •  Reasons for dropout:

•  GI upset from sugar alcohols •  Cost of meal replacements •  Taste fatigue with meal

replacements

Participant Comments – Benefits •  Improved satiety •  Helped limit food choices and

calories •  Encouraged carbohydrate

consistency •  Increased fruit and vegetable

consumption

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Case Study #1 – Barbara

•  42-year-old mom with T2DM •  DM Meds: metformin 1 g BID, glyburide 10 mg BID •  A1C = 7.9%; BMI = 35 •  Social Hx:

•  Works full time •  Busy with young kids

•  Diet/Weight Hx: •  Skips breakfast •  Snacking at HS •  Struggling with weight

•  Activity: Activities of Daily Living (ADLs) only

Case Study #1 – Barbara

Body weight (lbs)

BMI (kg/m2)

A1C (%) Meds

March 2006 (pre-study)

206 35 7.9 •  Metformin 1 g BID

•  Glyburide® 10 mg BID

Sept 2006

194 (↓12 lbs over 6

months)

33 6.4 •  Metformin 1 g BID

•  Glyburide® 5 mg BID

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Case Study #2 – Bob

•  60-year-old male with T2DM, arthritis, HTN, and hyperlipidemia

•  DM Meds: metformin 1g bid, Lantus® 90 u qhs, NovoRapid® 30 u tid •  A1C = 8.2 %; BMI = 42 •  Weight Hx: lifelong battle with weight, tried Xenical® in past •  Diet Hx:

•  Not fond of cooking – lives alone •  Drive-thru for breakfast •  Eats out for lunch with co-workers

•  Activity Hx: limited d/t ↑ weight/arthritis

Case Study #2 – Bob

Body weight (lbs)

BMI (kg/m2)

A1C (%) Meds

February 2007 (pre-study)

259 42.0 8.2 •  Metformin 1 g BID

•  Lantus® 90 units q HS

•  NovoRapid® 90 units/day

November 2007

246 (↓13 lbs over 6

months)

39.7 6.5 •  Metformin 1 g BID

•  Lantus® 40 units q HS

•  NovoRapid® 20 units/day

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Practical Tips

•  Mix with coffee for a mocha treat •  Add ice to make an “iced cappuccino” •  If hungry between meals, snack on vegetables, diet jello,

diet popsicles •  If thirsty between meals, drink water/tea/coffee/diet drinks •  Mix with fruit, milk, or yogurt to make a shake •  Coupons: www.glucerna.ca •  Recipes: www.glucerna.ca/english/DCFL-Recipes.html

Patient Education Tool

Available at www.hhsc.ca/pedl in Patient Education Library

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Conclusions

•  At 3 and 6 months, Partial MRT •  Significantly lowered body weight loss •  Significantly improved glycemic control •  Significantly decreased antihyperglycemic meds

•  Partial MRT is a viable short term option to stimulate weight loss

•  Transition individuals to a lifestyle program (healthy eating, activity, and behaviour change) to maintain and encourage further weight loss