Χάρης Δημοσθενόπουλος MΜedSci. PhDc Κλινικός Διαιτολόγος - Βιολόγος, Προϊστάμενος Τμήματος Κλινικής Διατροφής, Γ.Ν. «Λαϊκό» Αντιπρόεδρος ΕΜΠΑΚΑΝ

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1 Πόσο αποτελεσματική μπορεί να είναι η αλλαγή του τρόπου ζωής και διατροφής στη μείωση του σωματικού βάρους και των καρδιαγγειακών επεισοδίων σε άτομα με ΣΔ; Χάρης Δημοσθενόπουλος MΜedSci. PhDc Κλινικός Διαιτολόγος - Βιολόγος, Προϊστάμενος Τμήματος Κλινικής Διατροφής, Γ.Ν. «Λαϊκό» Αντιπρόεδρος ΕΜΠΑΚΑΝ ΚΑΛΑΜΑΤΑ

2 Η διατροφή και το περιβάλλον έχει αλλάξει με αρνητικές επιπτώσεις στην υγεία μας

3 Deaths Attributed to 19 Leading Factors, by Country Income Level, 2004 High blood pressure Tobacco use High blood glucose Physical inactivity Overweight and obesity High cholesterol Unsafe sex Alcohol use Childhood underweight Indoor smoke from solid fuels Unsafe water, sanitation, hygiene Low fruit and vegetable intake Suboptimal breastfeeding Urban outdoor air pollution Occupational risks Vitamin A deficiency Zinc deficiency Unsafe health-care injections Iron deficiency High income Middle income Low income Mortality in thousands (total: 58.8 million) Source: Adapted from GLOBAL HEALTH RISKS: Mortality and burden of disease attributable to selected major risks WHO Library Cataloguing-in-Publication Data World Health Organization 2009

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5 Αλλαγές τρόπου ζωής:therapeutic Lifestyle Changes (TLC) Therapeutic Lifestyle Changes (TLC) is recommended by various health organizations (American Diabetes Association, American Heart Association, and The Obesity Society, among others) as a sound therapeutic strategy for overweight or obese persons at risk for type 2 diabetes and/or coronary heart disease.

6 Therapeutic Lifestyle Changes Nutrient Composition of TLC Diet Nutrient Saturated fat Polyunsaturated fat Monounsaturated fat Total fat Carbohydrate Fiber Protein Cholesterol Total calories (energy) expenditure Recommended Intake Less than 7% of total calories Up to 10% of total calories Up to 20% of total calories 25 35% of total calories 50 60% of total calories grams per day Approximately 15% of total calories Less than 200 mg/day Balance energy intake and to maintain desirable body weight/ prevent weight gain

7 Η αποτελεσματικότητα της αλλαγής του τρόπου ζωής στη μείωση του σωματικού βάρους στο ΣΔ

8 Standard Dietary Recommendations Reduce intake by kcal/day to lose kg/wk Balanced deficit diet with: 10% kcal from saturated fat < 300 mg/day of cholesterol 2400 mg/day of sodium g/day of fiber Protein: ~ 15% of kcal Fat: 30% of kcal Carbohydrate: 55% of kcal NIH/NHLBI, NAASO. The Practical Guide: Identification, Evaluation, and Treatment of Overweight and Obesity in Adults

9 Παχυσαρκία-Διαβήτης: δύο παράλληλες επιδημίες

10 Οι ασθενείς με διαβήτη τύπου 2 είναι κατά κανόνα παχύσαρκοι ΒΜΙ / Γλυκαιμία ατόμων υψηλού κινδύνου για εμφάνιση διαβήτη που υποβλήθηκαν σε προσυμπτωματικό έλεγχο *P< * Μελέτη DEPLAN

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12 Ενεργειακό ισοζύγιο ADA DNSG Joslin CDA NICE (UK) ΟΜΟΦΩΝΙΑ Σε υπέρβαρους/παχύσαρκους: Απώλεια βάρους Μείωση της πρόσληψης θερμίδων Αύξηση της σωματικής δραστηριότητας Α ΕΔΕ

13 Παχυσαρκία και Σακχαρώδης Διαβήτης Η παχυσαρκία συνυπάρχει συχνότατα με μείζονες παράγοντες ΚΑΝ, όπως δυσλιπιδαιμία, υπέρταση και ΣΔ. Σε άτομα με ΣΔτ2 η απώλεια βάρους έστω και μέτρια, έχει ευμενή επίδραση στη ρύθμιση του σακχάρου Η απώλεια βάρους πρέπει να επιτυγχάνεται με υγιεινοδιαιτητική αγωγή (δίαιτα και άσκηση). Η πρόσληψη ενέργειας στη δίαιτα του παχύσαρκου διαβητικού πρέπει να μειωθεί κατά kcal/ημερησίως κάτω των υπολογιζόμενων ημερήσιων αναγκών του Η παράλληλη αύξηση της κατανάλωσης ενέργειας μέσω της άσκησης βοηθά σημαντικά στην επίτευξη του στόχου μέσα από προγράμματα παρέμβασης αλλαγή τρόπου ζωής.

14 Σύμφωνα με τις Κατευθυντήριες Οδηγίες ΕΔΕ 2013

15 Σκοπός: Να εκτιμηθεί σε υπέρβαρα διαβητικά άτομα η μακροπρόθεσμη επίδραση μιας εντατικής παρέμβασης στον τρόπο ζωής με: Απώλεια βάρους (στόχος: 10%) με μείωση των προσλαμβανόμενων θερμίδων και αύξηση της σωματικής δραστηριότητας. Καταληκτικά σημεία Θάνατος από καρδιοαγγειακά αίτια Μη θανατηφόρο έμφραγμα μυοκαρδίου Μη θανατηφόρο ΑΕΕ 5000 άτομα (60% γυναίκες) 11,5 έτη παρακολούθησης Αποτελέσματα:

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18 Μερικά στοιχεία για την παρέμβαση προσλαμβανόμενων θερμίδων Τουλάχιστον 7% του αρχικού ΣΒ < 30% λίπος < 10% κορεσμένο λίπος 15% πρωτεΐνη [Χρησιμοποιήθηκαν υποκατάστατα γευμάτων] σωματικής δραστηριότητας Τουλάχιστον 175 λεπτά/εβδομάδα (αντίστοιχη με έντονο περπάτημα) Προσέγγιση αλλαγής συμπεριφοράς Διαιτολόγος Ψυχολόγος Ειδικός σε προγράμματα άσκησης 6 μήνες: εβδομαδιαία βάση 6-12 μήνες: ανά δεύτερη εβδομάδα

19 LOOK AHEAD Αποτελέσματα στο πρώτο έτος Μέση απώλεια: 8,6% vs. 0.4% (8,1 κιλά) Diabetes Care 30: , 2007

20 Look AHEAD: Action for Health in Diabetes: Results at the 1-Year Follow-up Study Goal Intervention Group Usual Care Group P value Weight loss reduction 8.6% 0.7% <0.001 Increased fitness 20.9% 5.8% <0.001 Hemoglobin A 1c (<7%) 26.4% 5.4% <0.001 Blood pressure (<130/80 mm Hg) 15.1% 7.0% <0.001 LDL cholesterol (<100 mg/dl) 6.7% 8.0% All three cardiovascular risk factors 12.8% 6.5% <0.001 LDL = low-density lipoprotein Look AHEAD Research Group. Diabetes Care. 2007;30:

21 LOOK AHEAD Αποτελέσματα στο πρώτο έτος Diabetes Care 30: , 2007

22 Arch Intern Med. 2010;170(17):

23 Σωματικό βάρος Φυσική κατάσταση LOOK AHEAD Αποτελέσματα στα τέσσερα έτη

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30 Η αποτελεσματικότητα της αλλαγής του τρόπου ζωής στη μείωση των καρδιαγγειακών επεισοδίων στο ΣΔ

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32 Diet Evidence: Benefits of Fruits and Vegetables Nurses Health Study and Health Professional s Follow-up Study 126,399 persons followed for 8-14 years to assess the relationship between fruit and vegetable intake and adverse CV outcomes* Increased fruit and vegetable intake reduces CV risk *Includes nonfatal MI and fatal coronary heart disease CV=Cardiovascular, MI=Myocardial infarction Joshipura KJ, et al Ann Intern Med134:

33 Diet Evidence: Benefits of Whole Grains and Fiber 336,244 persons followed for 6-10 years to assess the relationship between dietary fiber intake and adverse CV outcomes RR=0.73, P<0.001 Increased dietary fiber intake reduces CV risk CV=Cardiovascular, CHD=Coronary heart disease Pereira MA et al. Arch Int Med 2004;164:370-76

34 Diet Evidence: Primary Prevention 22,043 adults evaluated for adherence to a Mediterranean diet, with points given for high consumption of vegetables, legumes, fruits, nuts, cereal, and fish and points subtracted for high consumption of meat, poultry, and dairy Variable Death from any cause Death from CHD Death from cancer # of Deaths/ # of Participants Fully Adjusted Hazard Ratio (95% CI) 275/22, ( ) 54/22, ( ) 97/22, ( ) High adherence to a Mediterranean diet is associated with a reduction in death Trichopoulou A, et al. NEJM 2003;348:2595-6

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36 Diet Evidence: Secondary Prevention Lyon Diet Heart Study 605 patients following a MI randomized to a Mediterranean* or Western** diet for 4 years A Mediterranean diet reduces cardiovascular events *High in polyunsaturated fat and fiber, **High in saturated fat and low in fiber De Lorgeril M et al. Circulation 1999;99:

37 HbA1c Συστ Αρτ Πίεση LOOK AHEAD Αποτελέσματα στα τέσσερα έτη

38 HDL-C LDL-C The combination of weight loss and increased physical activity had the greatest impact on HDL-cholesterol levels and parallel the type of approach used in Look AHEAD. The effects of lifestyle intervention on HDL-C may provide important long-term cardiovascular benefit LOOK AHEAD Αποτελέσματα στα τέσσερα έτη

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43 ΟN FRIDAY, OCTOBER 19, 2012, THE NATIONAL Institutes of Health (NIH) announced that the lifestyle intervention was stopped early in NIH funded study of weight loss in overweight and obese adults with type 2 diabetes after finding no harm, but no cardiovascular benefits. The primary study question of the long-term Look AHEAD (Action for Health in Diabetes) Study had been answered: An intensive lifestyle intervention program aimed at a 10% weight loss and 175 minutes of physical activity per week did not reduce cardiovascular events (defined as heart attack, stroke, hospitalization for angina,or death) in people with type 2 diabetes compared with a program of diabetes support and education.1 A review of the primary study results, along with careful consideration of the previously published data, can put the study s results in perspective and go beyond the headlines.

44 Curr Nutr Rep Dec;3(4): The Look AHEAD Trial: A Review and Discussion Of Its Outcomes. Pi-Sunyer X1. Author information Abstract The LookAhead trial was a randomized controlled trial comparing an Intensive Lifestyle Intervention (ILI) to a Diabetes Support and Education (DSE) in overweight and obese type 2 diabetes patients to track the development of cardiovascular disease over time. The triai intervention was stopped for futility after a median follow-up of 9.6 years. While there was a differential effect on weight loss and fitness between the two groups, there was no effect on cardiovascular outcomes. Cardiovascular events were less than half the projected rate per year in the DSE group: thus there was a very low over-all rate of events in both groups. There were many other health benefits of ILI, including improved biomarkers of glucose and lipid control, less sleep apnea, lower liver fat, less depression, improved insulin sensitivity, less urinary incontinence, less kidney disease, reduced need of diabetes medications, maintenance of physical mobility, improved quality of life and lower costs.

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47 We have considered several possible explanations for the lack of a significant difference in the rates of cardiovascular events between groups. 1. One possibility is that the study lacked sufficient power. 2. Another possibility is that a sustained weight loss of more than that achieved in the intervention group may be required to reduce the risk of cardiovascular disease. 3. Third, the provision of educational sessions and the increased use of statins in the control group, as compared with the intervention group, may have lessened the difference between the two groups.

48 It is likely that an intervention more focused on changes in dietary composition would have given different results in terms of CVD outcomes. In order to achieve the most powerful effect on cardiovascular risk in type 2 diabetic patients, weight reduction should be combined with increased physical exercise and changes in the diet composition aiming at a higher consumption of foods rich in fiber and with a high vegetable/animal fat ratio in addition to a reduction of salt intake.

49 Άλλες μελέτες A Cochrane intervention review was suggestive of a reduction in cardiovascular risk by modification of dietary fat, but not reduction of total fat, in long-term trials [Hooper L, Summerbell CD, Thompson R, Sills D, Roberts FG, Moore H, et al. Reduced or modified dietary fat for preventing cardiovascular disease. CDSR CD pub2. Issue 7. Art. No.: CD ]. Recent data from the EPIC study showed that the intake of some food groups e fruit, vegetables, legumes, nuts, seeds, pasta and poultry e were associated with a lower, while soft drinks, butter, margarine and cakes with a higher mortality risk, and indicated that people with diabetes may benefit more from a healthy diet than people without diabetes [Sluik D, Boeing H, Li K, Kaaks R, Johnsen NF, Tjønneland A, et al. Lifestyle factors and mortality risk in individuals with diabetes mellitus: are the associations different from those in individuals without diabetes? Diabetologia 2014;57(1): 63e72.]. A Mediterranean style diet reduced the mortality risk associated with diabetes in the Melbourne Collaborative Cohort Study [Hodge AM, English DR, Itsiopoulos C, O Dea K, Giles GG. Does a Mediterranean diet reduce the mortality risk associated with diabetes: evidence from the Melbourne Collaborative Cohort Study. Nutr Metab Cardiovasc Dis 2011;21(9):733e9.].

50 Άλλες μελέτες In an Italian middle-aged male population, a healthy Mediterranean dietary pattern showed a protective effect on the occurrence of fatal coronary heart disease events at 20 and 40 years [Menotti A, Alberti-Fidanza A, Fidanza F. The association of the Mediterranean Adequacy Index with fatal coronary events in an Italian middle-aged male population followed for 40 years. Nutr Metab Cardiovasc Dis 2012;22(4):369e75.]. In the primary prevention study PREDIMED, Mediterranean diets enriched in extra-virgin olive oil or in nuts reduced the primary outcome (acute myocardial infarction, stroke, or death from cardiovascular causes) compared with a low-fat American Heart Association diet [Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aro s F, et al., for the PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a mediterranean diet. N Engl J Med 2013;368:1279e90.].

51 Άλλες μελέτες Dietary interventions aiming at improving the composition of the western diet favorably influence the main mechanisms that drive CVD risk in metabolic patients, i.e. insulin resistance, dyslipidemia, and hypertension. In isoenergetic conditions, decreasing saturated fatty acid and increasing monounsaturated fatty acid improves insulin sensitivity, although not in individuals with a high fat intake, in addition to decreasing LDL-cholesterol, and blood pressure. Vessby B, Substituting dietary saturated for monounsaturated fat impairs insulin sensitivity in healthy men and women: the KANWU Study. Diabetologia 2001 Mar;44(3):312e9., Rivellese AA, et al. Effects of dietary saturated, monounsaturated and n-3 fatty acids on fasting lipoproteins, LDL size and post-prandial lipid metabolism in healthy subjects. Atherosclerosis 2003 Mar;167(1):149e58. Rasmussen BM et al., KANWU Study Group. Effects of dietary saturated, monounsaturated, and n-3 fatty acids on blood pressure in healthy subjects. Am J Clin Nutr 2006;83(2): 221e6.]. A recent meta-analysis provided convincing evidence that low glycemic index diets, especially when accompanied by an increase in dietary fiber, reduce total and LDLcholesterol, independently of weight loss [Goff LM, Cowland DE, Hooper L, Frost GS. Low glycaemic index diets and blood lipids: a systematic review and metaanalysis of randomised controlled trials. Nutr Metab Cardiovasc Dis 2013;23(1):1e10.].

52 Ο ρόλος της άσκησης The other component of the weight reduction program was 175 min per week of moderate-intensity physical activity and exercise. This target, although more ambitious than in the Diabetes Prevention Program (150 min/week) because higher levels of physical activity are required to maintain weight loss e was lower than the one recommended for losing weight [Donnelly JE, Blair SN, Jakicic JM, Manore MM, Rankin JW, Smith BK, American College of Sports Medicine, American College of Sports Medicine Position Stand. Appropriate physical activity intervention strategies for weight loss and prevention of weight regain for adults. Med Sci Sports Exerc 2009;41(2):459e71.]. High levels of physical activity, however, may induce favorable metabolic changes in the absence of significant weight loss.

53 Eur J Prev Cardiol May;21(5): Effect of improved fitness beyond weight loss on cardiovascular risk factors in individuals with type 2 diabetes in the Look AHEAD study. Gibbs BB1, Brancati FL, Chen H, Coday M, Jakicic JM, Lewis CE, Stewart KJ, Clark JM; (for the Look AHEAD Research Group). Ο ρόλος της άσκησης BACKGROUND: Because lifestyle-induced improvements in cardiovascular risk factors vary substantially across individuals with type 2 diabetes, we investigated the extent to which increases in fitness explain cardiovascular risk factor improvements independent of weight loss in a lifestyle intervention. CONCLUSION: Increased fitness explained statistically significant but small improvements in several cardiovascular risk factors beyond weight loss. Further research identifying other factors that explain cardiovascular risk factor change is needed.

54 In conclusion, while the effect of weight reduction on diabetes prevention is well demonstrated, that on CVD remains uncertain. However, the overall results of the trial do not indicate that diet and exercise are not important in the treatment of type 2 diabetes. On the contrary, they indicate that a modest weight loss can have substantial health benefits for overweight and obese people with type 2 diabetes, reinforcing the evidence that CVD risk factors can be corrected by lifestyle changes. Most likely, in order to reduce the risk of CVD in diabetic persons it is important that the lifestyle intervention is started early in the course of the metabolic derangements and is based on a multifactorial approach.

55 Thus, the increased utilization of medications that lower CV disease in combination with the selection toward lower-risk participants described above may have led to a much lower yearly CVD event rate (0.7 %) than expected by the investigators (3.125 %) at the time the study was originally designed. Look AHEAD is a unique study because it is the only longterm study in participants with type 2 diabetes looking at cardiovascular outcomes that did not include glycemic targets and, in contrast to studies such as ACCORD, ADVANCE, VADT or UKPDS no glucose lowering medications were provided by the study centers.

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