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5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidencebased Recommendations Sarah Kim, MD Assistant Clinical Professor, UCSFSFGH No financial disclosures

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Page 1: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

5/28/2013

1

Medical Nutrition Therapy (MNT) for Diabetes

Evidence‐based Recommendations

Sarah Kim, MD

Assistant Clinical Professor, UCSF‐SFGH

No financial disclosures

Page 2: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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Uses of MNT in diabetes

To treat obesity and prevent diabetes

For metabolic control of diabetes

To delay and manage complications of 

diabetes

ADA. Diabetes Care 2008; 31:s1‐s78

Objectives

1. Review evidence supporting the following nutritional practices in relation to glycemic control in diabetes:

– Carbohydrate counting & consistency

– Carbohydrate restriction

– Low glycemic index foods

– Fiber

Page 3: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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Objectives

2. Review evidence supporting the following nutritional practices in relation to other health outcomes in diabetes:

– Mediterranean diet 

– Low fat, calorie restricted diet (Look AHEAD)

• Carbohydrate Counting

1. Glycemic Control

• Carbohydrate Consistency• Limiting sucrose

• Low vs. High GI foods

• Fiber intake

• Mediterranean diet• Calorie restricted, low fat

• Carbohydrate restriction

Definitely Beneficial

Page 4: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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I. CARBOHYDRATE COUNTING & CONSISTENCY

Diabetes Control and Complications Trial

• Although not a primary dietary intervention, the DCCT involved extensive nutritional training in the intensive arm

• Techniques used: carbohydrate consistency, carbohydrate counting, the exchange system, and healthy food choices

• Greater HbA1c reductions were associated with adherence to dietary advice – Following overall meal plan

– Adjusting carbohydrate intake or insulin in response to hyperglycemia

– Not over treating lows glucoses

Delahanty L. Diabetes Care. 1993;16(11):1453‐8.

Page 5: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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Dose Adjustment for Normal Eating (DAFNE study)

• Multicenter randomized control trial examining the benefit of 5‐day outpatient intensive diabetes education with emphasis on carb counting and flexible eating 

• 164 motivated subjects with T1DM and moderate to poor glycemic control

• Outcomes: Glycemic control, hypoglycemia rate, QOL

Baseline Characteristics

N=164

Age, yr 40 ± 9

Duration diabetes, yr 16.6 ± 9.6

HbA1c 9.4%

Retinopathy 37%

Neuropathy 17%

DAFNE Study Group. BMJ. 2002;325:746‐751

Outcomes

‐0.5% vs baseline, p=0.001

‐1.0% vs. baseline, p<0.0001

Control arm

DAFNE Study Group. BMJ. 2002;325:746‐751

Page 6: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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Outcomes

5

7

9

11

Pre Post

HbA1c, %

6 months

Intervention

Control

*

Freedom to Eat Overall QOL

‐6

‐5

‐4

‐3

‐2

‐1

0

Pre Post Pre Post

**

* p<0.05DAFNE Study Group. BMJ. 2002;325:746‐751

(less negative = better)

DAFNE Expansion

• 31 centers throughout UK & Ireland, 1163 participants

• Retrospective database analysis of 639 participants

8.51 8.24

5

6

7

8

9

Pre Post

HbA1c, %

1 Year Follow Up

No changes in weight, lipids or blood pressure

*

Hopkins et al. Diabetes Care. 2012; 35:1638‐1642

Page 7: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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DAFNE Expansion

0

1

2

3

4

Pre Post Pre Post

Episodes/subject/yr

Severe Hypoglycemia

Hypoglycemia aware(sx’s with BG <54)

Hypoglycemia unaware

*

*

Modest improvements in quality of life, depression and anxiety

Hopkins et al. Diabetes Care. 2012; 35:1638‐1642

Carb counting in T2DM

• 24 week randomized control trial comparing a fixed mealtime insulin dosing vs. carb counting in patients with insulin‐requiring type 2 diabetes

Bergenstal et al. Diabetes Care. 2008;31:1305‐1310

Simple AlgorithmN=136

Carbohydrate CountN=137

Age 55 yr 55 yr

BMI, kg/m2 38 37

HbA1c 8.1% 8.3%

Diabetes duration 13 yr 13 yr

>2 insulin injections/day 68% 58%

Page 8: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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Intervention

• Initial insulin doses:

– Glargine: 50% of total daily dose before randomization

– Glulisine: 

• 50% of total daily dose divided into 50%/33%/17% according to meal size

‐OR‐

• Carb:insulin ratio plus a simple correction factor (“± a few units”)

Bergenstal et al. Diabetes Care. 2008;31:1305‐1310

Intervention

• Targets: Fasting <95, pre‐prandial <100, bedtime <130 mg/dl

• Metformin continued if used at baseline. 

• Weekly insulin titration by algorithm over the phone

• Participants kept diaries (glucoses, insulin dose, carb intake, activity level, low glucoses)

Bergenstal et al. Diabetes Care. 2008;31:1305‐1310

Page 9: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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Outcomes

Bergenstal et al. Diabetes Care. 2008;31:1305‐1310

Outcomes

Simple Algorithm Group Carbohydrate Count Group

Severe Hypoglycemia(BG <36)

0.89 events/patient‐years(53 episodes in 19 subjects)

0.67 events/patient‐years(37 episodes in 19 subjects)

P=0.58

Hypoglycemia (BG <50)

4.9 events/patient‐years 8.0 events/patient‐years P=0.02

Weight +3.6 kg (3.4%) +2.4 kg (2.3%)  P=0.06

BMI  +1.28 kg/m2 +0.83 kg/m2 P=0.037

Triglycerides ‐8.19 mg/dl (p=0.17) ‐13.19 (p=0.008)

Bergenstal et al. Diabetes Care. 2008;31:1305‐1310

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Carbohydrate counting/estimating

• Carbohydrate counting has glycemic benefits in type 1 diabetes, with additional modest benefits in quality of life

• Carbohydrate counting improves glycemic control in type 2 diabetes who need mealtime insulin and may be equally effective as fixed‐dose insulin coupled with consistent carbohydrate meals

CARBOHYDRATE AMOUNT

Page 11: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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Carbohydrate intake and glycemic control

• Observational data from large studies involving T1DM1 and T2DM2 show an association between higher carb/lower fat intake with lower HbA1c

• Interventional studies show conflicting results

1. Delahanty et al. Am J Clin Nutr 2009; 89:518‐524

2. Xu et al. Am J Clin Nutr 2008; 86:480‐487

Carbohydrate restricted diets in T2DM

Study N Intervention Control Length

Samaha2003

51 37% CHO+41% Fat 51% CHO+33% Fat  6 mo

Stern 2004

109 120g CHO+93g Fat+74g Pro 230g CHO+69gFat+74g Pro 1 yr

Westman2008

50 19% CHO+59% Fat 44% CHO+36% Fat 6 mo

Wolever2008

156 40% CHO+40% Fat 50% CHO+25% Fat(low GI)

1 yr

Haimoto2008

127 45% CHO+33% Fat 57% CHO+26% Fat 1 yr

Davis 2009

105 20‐25g CHO 25% Fat  1 yr

Elhayany2010

124 35% CHO+45% Fat(low GI, high MUFA)

55%CHO+30%Fat(low GI, high MUFA)

1 yr

Iqbal2010

144 60g CHO+60g Fat+55g Pro 190g CHO+40g Fat+80g Pro(+Orlistat)

1 yr

Ajala et al. Am J Clin Nutr. 2013:97:505‐16

pp j (p )

Samaha et al (6 month study):• Severely obese American subjects, 51 of whom had diabetes • Randomized to Low Carb (30g CHO per day) vs. Low Fat Diet (<30% fat)• High attrition: 33% in Low Carb, 47% in Low Fat• Weight loss and TG levels were better in Low Carb group • HbA1c dropped in subjects with diabetes: 7.8‐> 7.2% (p=0.06)

Wolever et al (1 yr study):• 156 Canadian subjects with diabetes • Randomized to Low Carb (40% CHO per day) vs. Low GI or Low Fat• No significant differences in HbA1c, lipids, weight• Lower diastolic blood pressure (‐3 mm/Hg) in low carb group

Haimoto et al (1 year study):• 127 Japanese subjects with T2DM • Randomized to simple carb reducing instructions vs. unrestricted diet• In Low Carb, HbA1c drop : 7.5‐> 6.7% (p<0.001) and BMI, LDL lowered significantly

Page 12: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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Carbohydrate restricted diets in T2DM

Ajala et al. Am J Clin Nutr. 2013:97:505‐16

Carbohydrate amount

• In studies conducted thus far, reducing percent of dietary carbohydrates may have a small benefit in glycemic control and lipid profile

• Studies are heterogeneous in terms of degree of carbohydrate restriction and difficult to compare

Page 13: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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GLYCEMIC INDEX

www.glycemicindex.com

High GI (>70)White riceWhite breadPotatoCornflakesPizzaCarrots

Low GI ( <55)Brown riceWhole grain breadTortillaMilkBeansSpaghetti

Page 14: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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GlycemicIndex

Glycemic Load

71 4

41 16

Elliott et al. Cochrane Database Syst Rev. 2009; 21

Impact of low GI diet on HbA1c 

Children with T1DM

Page 15: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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Low GI vs High‐Cereal Fiber Diet

155 subjects with T2DM randomized to Low GI (69.6) or High GI (83.5) diet

Jenkins et al . JAMA 2008; 300(23):2742‐53.

Low GI diet in T2DM

Ajala et al. Am J Clin Nutr. 2013:97:505‐16

Page 16: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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Glycemic Index

• Choosing low GI foods may have a small benefit in glycemic control in diabetes

FIBER

Page 17: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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Fiber and glycemic control

Study Population Duration Intervention Control Findings

Milne1994

Type 2 DiabetesN=64

18 month 30g Fiber(21g achieved)

21 g Fiber (17g achieved)

No change in A1c, lipids, or weight

Giacco2000

Type 1 DiabetesN=54

6 month 50g Fiber(40g achieved)

15g Fiber(15g achieved)

In hi fiber compliant, ‐↓0.2% A1c‐↓hypos by 0.8 x/mo‐no change in lipids

• Most studies are small and of short duration (not shown)

Franz et al. J Am Diet Assoc. 2010;110:1852‐1889

Fiber and T1DM

Giacco et al. Diabetes Care. 2000; 23: 1461‐1466

• Lo Fib: HbA1c 8.6 9.1% (p=NS)• Hi Fib: HbA1c 8.8 8.6%, p<0.05

Page 18: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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Fiber and glycemic control

• There is insufficient evidence to recommend high fiber diets to improve glycemic control

• Recommend daily intake for all = 14g/1000kcal

MEDITERRANEAN DIET

Page 19: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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“Mediterranean diet pyramid: a cultural model for healthy eating”

Walter Willet, MD, MPH

• Diet consumed in Crete and most of Greece and Southern Italy in 1960s 

• Long life expectancy• Low rates of CVD and certain cancer

Willet et al. Am J Clin Nutr. 1995 61:1402S‐1406S

Mediterranean Diet vs. AHA Diet• 215 overweight subjects with 

newly diagnosed T2DM

• All on 1500 or 1800 kcal diet

• 175 min mod‐intense exercise per week

• MED: <50% CHO, +Olive Oil

• AHA: <30% Fat

• Nutrition advice given every 2‐4 weeks by nutritionist

• Follow up of 4 years

Esposito et al. Ann Intern Med. 2009;151(5):306‐314

Page 20: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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Mediterranean Diet vs. AHA Diet

Esposito et al. Ann Intern Med. 2009;151(5):306‐314

Mediterranean Diets in T2DM

Ajala et al. Am J Clin Nutr. 2013:97:505‐16

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• Multicenter randomized trial of 7447 subjects with high risk of CVD, 50% with diabetes

– Among subjects with diabetes: 30% on oral agent and 5% on insulin 

• Randomized to: MED with olive oil, MED with nuts, Low fat diet x 5 yrs

• Quarterly individual or group education sessions, shopping lists, free nuts or oil

• Primary outcome: major cardiovascular event (MI, CVA, CV death)

Estruch et al. N Engl J Med 2013; 368:1279‐1290

The Diets

Mediterranean Low Fat

Olive Oil** ≥ 4 tbsp/day Low fat dairy products≥3 servings/day

Tree nuts and peanuts** ≥ 4 servings/week Bread, potatoes, pasta, rice≥3 servings/day

Fresh Fruits ≥ 3 servings/day Fresh fruits ≥3 servings/day

Vegetables ≥ 2 servings/day Vegetables ≥2 servings/week

Fish (esp fatty*), seafood ≥ 3 servings/week Lean fish and seafood ≥3 servings/week

Legumes ≥ 3 servings/week

Sofrito* (tomato sauce) ≥ servings/week

White meat instead of red meat

Wine ≥ 7 glasses/week

*sofrito: tomato sauce with onions, spices and olive oil**discouraged in low fat diet

Estruch et al. N Engl J Med 2013; 368:1279‐1290

Page 22: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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Urinary Measures of Compliance with Mediterranean Diet

Estruch et al. N Engl J Med 2013; 368:1279‐1290

Dietary Changes

Baseline Dietary Intake Dietary Changes vs. Controls

~43% CHO

~40% Fat

20% MUFA

~17% Protein

• Adherence to Mediterranean diet score = 8 (out of 14)

• 0.3 servings legumes/week

• 0.4 servings fish/week

• 50g/32g olive oil/day

• 0.9g/6g nuts/week

• Major macronutrient change was increase in fat 

• Adherence to Mediterranean diet score = 10.5 (out of 14)

Estruch et al. N Engl J Med 2013; 368:1279‐1290

Page 23: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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Primary Outcome

Absolute #Events:EVOO‐96Nuts‐ 83 Control‐109

Estruch et al. N Engl J Med 2013; 368:1279‐1290

Who benefitted?

Subgroup HR Primary endpoint

Diabetes  0.71 (0.53‐0.96)

No Diabetes 0.67 (0.45‐1.01)

Who also benefitted: • Male • ≥70 yo• Hypertensive • Dyslipidemic• Obese• Large waist• More adherent to Mediterranean diet at baseline (score of 9 out of 14)

Estruch et al. N Engl J Med 2013; 368:1279‐1290

Page 24: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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Look AHEAD

Look AHEAD

• Randomized control trial comparing a 5 year intensive lifestyle intervention (ILI) vs. diabetes support and education (DSE) for the prevention of major cardiovascular events in T2DM over 11.5 year follow up

• Intervention: Aim for 7% weight loss with a reduced calorie, low fat (<30% fat, <10% saturated fat), 15% protein diet and 175 min of mod‐strenuous exercise per week

• Included: BMI≥25, HbA1c <11%

• Participants underwent screening treadmill stress test and excluded if couldn’t complete or abnormal

https://www.lookaheadtrial.org/public/LookAHEADProtocol.pdf

Page 25: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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Look AHEAD

• At 3 yrs, the CV event rate in control arm was only 0.7%. 

• What could be the reasons?

– Better management of CVD risk factors

– Exclusion of those with abnormalities on stress test

– Study population different from community cohorts from which risk estimates were derived

• Study stopped for futility

Brancati et al. Clinical Trials 2012:9:113

Look Ahead Results

Moderate gains in diabetes medication discontinuation, blood pressure, TGs in ILI

YearThe Look AHEAD Research Group. Ann Intern Med. 2010:170:1566‐75

Page 26: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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Diabetes Remission in Look AHEAD

Gregg et a. JAMA 2012;308:2489‐2496

Diabetes Remission in Look AHEAD

Higher rates of remission in those with:• Less than 2 yr diabetes duration • Baseline lower A1c • Baseline not on insulin• More weight loss in year 1• Highest fitness change during study

Gregg et a. JAMA 2012;308:2489‐2496

Page 27: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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Mediterranean and Look AHEAD Diets and CVD risk 

• Mediterranean diet may be beneficial in reducing medication need in newly diagnosed diabetes and cardiovascular events in people with diabetes

• A low fat weight loss diet combined with exercise (Look AHEAD)  improves glycemic control and CV risk factors. This diet did not show a reduction in CV events due to study design flaws. 

Take Home Points

• Carbohydrate counting and consistency in T1DM and insulin requiring T2DM improves glycemic control

• Low GI foods, fiber and low carb diets may have a modest impact on glycemic control

• Both the Mediterranean diet and a low fat, calorie‐restricted diet improve the course of diabetes

• Mediterranean diet may reduce primary cardiovascular events in diabetes

Page 28: Medical Nutrition Therapy (MNT) Recommendations · 5/28/2013 1 Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations Sarah Kim, MD Assistant Clinical Professor,

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Thank you