[PDF] - Medical Nutrition Therapy (MNT) for Diabetes Evidence based PDF Document

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Medical Nutrition Therapy (MNT) for Diabetes Evidence‐based Recommendations

Sarah Kim, MD Assistant Clinical Professor, UCSF‐SFGH No financial disclosures

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Uses of MNT in diabetes To treat obesity and prevent diabetes For metabolic control

f 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

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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

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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.

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Dose Adjustment for Normal Eating (DAFNE study)

Multicenter randomized control trial examining the benefit of 5‐day
utpatient 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

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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 Pre Post Pre Post * * * p<0.05 DAFNE 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

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DAFNE Expansion

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 Algorithm N=136 Carbohydrate Count N=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%

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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

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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

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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

Samaha 2003 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 Westman 2008 50 19% CHO+59% Fat 44% CHO+36% Fat 6 mo Wolever 2008 156 40% CHO+40% Fat 50% CHO+25% Fat (low GI) 1 yr Haimoto 2008 127 45% CHO+33% Fat 57% CHO+26% Fat 1 yr Davis 2009 105 20‐25g CHO 25% Fat 1 yr Elhayany 2010 124 35% CHO+45% Fat (low GI, high MUFA) 55%CHO+30%Fat (low GI, high MUFA) 1 yr Iqbal 2010 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

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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

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GLYCEMIC INDEX

www.glycemicindex.com High GI (>70) White rice White bread Potato Cornflakes Pizza Carrots Low GI ( <55) Brown rice Whole grain bread Tortilla Milk Beans Spaghetti

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Glycemic Index 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

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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

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Glycemic Index

Choosing low GI foods may have a small

benefit in glycemic control in diabetes

FIBER

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Fiber and glycemic control

Study Population Duration Intervention Control Findings Milne 1994 Type 2 Diabetes N=64 18 month 30g Fiber (21g achieved) 21 g Fiber (17g achieved) No change in A1c, lipids, or weight Giacco 2000 Type 1 Diabetes N=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

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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

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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

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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
r 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

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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

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Primary Outcome

Absolute #Events: EVOO‐96 Nuts‐ 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

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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

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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 Year

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

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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

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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

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