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 1
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. 2
The Challenge! Obesity: A Multifaceted Issue! Food Co-morbid conditions Inactivity OBESITY Genetics Medications Psychological factors 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! 3
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. 4
Wadden, et al. 2009 Results sults Results after one year: Key assessments Weight, Wt, % change % change + insulin - insulin Meal replacement users Look AHEAD Study ILI* N=2570-7.6 ± 7-8.7 ± 6.9 Usual care N=2570-0.3 ± 5.1-0.8 ± 4.7 A1C, % -0.67 ± 0.02 0.14 ± 0.02 Fasting glucose, mg/dl -21 ± 0.9-7.2 ± 0.9 TG, mg/dl -30 ± 2.0-14.6 ± 1.8 *Intensive Lifestyle Intervention Wadden TA, et al. Obesity 2009;17;713-22. Wadden, et al. 2009 Results Results after one year: 1st 2nd 3rd 4th Reduction in initial weight in ILI participants 117 MRs 5.9% 277 MRs 7.2% 406 MRs 9.4% Quartile of meal replacement (MR) 608 MRs 11.2% 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 *Intensive Lifestyle Intervention Wadden TA, et al. Obesity 2009;17;713-22. 5
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 6
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 1 Health 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 Science Behind Glucerna Normal Digestion and Absorption (Sucrose, glucose, and starches) Slow Digestion and Absorption (Fibersol + FOS) Source: http://glucerna.ca/english/theglucernascience-drinks.html. 7
Comparison of Diabetes Nutritional Drink Products Glucerna 250 ml can Glucerna 2 37 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 Adjusted Mean Change in Plasma Glucose over Time * Original Glucerna Glucerna bo,le 66 % lower than the standard nutri5onal formula * p< 0.001 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. 8
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 9
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) 10
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/m 2 ) 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 0-2 kg -4-6 -8-3.4 kg * - 6.1 kg * 3 months 6 months -10 Compared to baseline, * = p<0.01 11
Results Glycemic Control 8 7.5 A1C (%) 7 6.5 * 6 0 3 6 Number of months Compared to baseline, * = p<0.01; = p<0.05 Results Insulin TDD Change % Insulin TDD Change 0-5 -10-15 -20-25 -30-17 % * - 24 % * 3 months 6 months Compared to baseline, * = p<0.01 12
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 13
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 March 2006 (prestudy) Sept 2006 Body weight (lbs) BMI (kg/m 2 ) A1C (%) Meds 206 35 7.9 Metformin 1 g BID Glyburide 194 ( 12 lbs over 6 months) 10 mg BID 33 6.4 Metformin 1 g BID Glyburide 5 mg BID 14
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/m 2 ) A1C (%) Meds February 2007 (prestudy) November 2007 259 42.0 8.2 Metformin 1 g BID Lantus 246 ( 13 lbs over 6 months) 90 units q HS NovoRapid 90 units/day 39.7 6.5 Metformin 1 g BID Lantus 40 units q HS NovoRapid 20 units/day 15
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 16
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 17