DIABETES THE NEW EPIDEMIC Number of people with diabetes (20-79 years), 2013 Tot: 382,000,000 in 2013 Tot: 471,000,000 in 2035 IDF Diabetes Atlas, 6th Edition, 2013 Trends in age-standardized diabetes prevalence by regions in MALES (1980-2008) High income regions Central/Eastern Europe 20 Europe/North America Sub-Saharan Africa Oceania 16 Diabetes Prevalence (%) 12 8 4 Central Asia, North 20 Africa, Middle-East South Asia East Asia and SE Asia World 16 12 8 4 1985 1995 Southern America 20 16 Central/Andean America 2005 High income Asia 12 8 4 1985 1995 2005 1985 1995 2005 1985 1995 2005 Danaei et al. Lancet 2011 Trends in age-standardized diabetes prevalence by regions in FEMALES (1980-2008) High income regions Central/Eastern Europe 20 Europe/North America Sub-Saharan Africa Oceania 16 Diabetes Prevalence (%) 12 8 4 Central Asia, North 20 Africa, Middle-East South Asia East Asia and SE Asia World 16 12 8 4 1985 1995 Southern America 20 16 Central/Andean America 2005 High income Asia 12 8 4 1985 1995 2005 1985 1995 2005 1985 1995 2005 Danaei et al. Lancet 2011 Increased prevalence of diabetes in children and adolescents Results from prescription data from a UK general practice database Overall prevalence of antidiabetic drug use in children and adolescents by age on IMS, 1998-2005 inclusive girls boys and overall Hsia Y et al., British Journal of Clinical Pharmacology, 2008 Increasing use of antidiabetic drugs among children and adolescents * * * Prevalence of insulin, oral antidiabetic and oral antidiabetic drugs with a diabetes indication amongst children and adolescents aged 0-18 (with 95% CIs), insulin oral antidiabetic drugs with diabetes indication oral antidiabetic drugs ; *a significant trend for increasing use (p< 0.001). Hsia Y et al., British Journal of Clinical Pharmacology, 2008 Type 1 diabetes (15%) It is caused by an autoimmune reaction, where the body’s defence system attacks the insulinproducing beta cells in the pancreas. The body can no longer produce the insulin that it needs. Type 2 diabetes (85%) It is the most common type of diabetes. It usually occurs in adults, but it is increasingly seen in children and adolescents. The body is able to produce insulin but either this is not sufficient or the body is unable to respond to its effects. Projections of the number of individuals aged <20 years with type 1 diabetes –2010 to 2050 in the US population 2010 TOT = 179,388 A global increase of 23% 2050 TOT = 587,488 Imperatore et al. Diabetes Care 2012 Projections of the number of individuals aged <20 years with type 2 diabetes –2010 to 2050 in the US population 2010 TOT = 22,820 A global increase of 49% 2050 TOT = 84,131 Imperatore et al. Diabetes Care 2012 Prevalence of type 2 diabetes in urban and rural areas in the Arabic-speaking countries, 2011 Badran M and Laher I, International Journal of Endocrinology, 2012 Type 2 diabetes prevalence in South Africa, 2009 Betram MY et al., Global Health Action 2013 Prevalence of type 2 diabetes in Asian countries in 2013 data source: http://www.idf.org/diabetesatlas/data-visualisations Abdullah N et al., International Journal of Endocrinology, 2014 Worldwide prevalence of obesity Source: World Health Organization (WHO), 2012 Obesity prevalence is high in developing countries Prevalence of obesity in Arabian countries in adult males and females aged between 15 and 100 years, WHO estimates, 2010. Badran M et al., Journal of Obesity, 2011 Obesity prevalence in adults (Italy), 2011 Trentino 7.5% Lombardia Valle d’Aosta 8.9% 8,3% Piemonte 9.1% Friuli-V.G. 11.8% Veneto 9.9% E.Romagna 12.0% Marche 9.6% Abruzzo 8.7% Liguria 8.3% Toscana 8.7% Umbria 11.2% Lazio 9.2% Campania 10.9% Sardegna 10.2% Molise 13.5% Puglia 12.6% Basilicata Calabria 13.1% 11.4% Sicilia 9.8% Source: ISTAT 2013 Percentage of US adults who were obese or diagnosed with diabetes Obesity (BMI 30 KG/m2) Diabetes Centre for Disease Control and Prevention: National Diabetes Surveillance System http://apps.nccf.cdc.gov/DDTSTRS/default.aspx. Accessed March 2013 Obesity prevalence remains high altough no significant changes between 2003-2012 9120 participants in the 2011-2012 nationally representative National Health and Nutrition Examination Survey Childhood obesity (2-19 years) Adult obesity (>20 years) Ogden et al. JAMA 2014 the prevention window Natural history of type 2 diabetes Progression of disease Insulin resistance Hepatic glucose production Insulin level β-cell function 4–7 years Post-prandial glucose Fasting glucose Impaired Glucose Tolerance Frank Diabetes Diabetes Diagnosis Relative Risk (95% CI) Combined impaired fasting glucose (IFG) + impaired glucose tolerance (IGT) confers the highest risk of diabetes progression Isolated IGT Isolated IFG Metanalysis of total risk of pre-diabetes and diabetes progression, based on 21 cohort studies and 9 RCT (follow-up: 1-17 years) Gerstein HC et al. Diabetes Research and Clinical Practice 2007 Prediabetes increases the risk for cardiovascular events and death Relative risk of death is linear by 2h-PG – DECODE study DECODE study group. Lancet 1999 Pathophysiological defects in type 2 diabetes β-Cell dysfunction Insulin resistance Increased glucose production by liver Kahn CR et al. Joslin’s Diabetes Mellitus. 14th ed. Lippincott Williams & Wilkins; 2005 Loss of first phase insulin secretion in type 2 diabetes Insulin secretion (pmol/min) 800 600 normal 400 Type 2 diabetes 200 breakfast 0 6.00 10.00 lunch 14.00 dinner 18.00 22.00 2.00 6.00 time Polonsky KS et al. N Engl J Med, 1988 -cell mass: decline over diabetes continuum The United Kingdom Prospective Diabetes Study (UKPDS) 2 80 60 1 40 20 P < 0.0001 Insulin resistance Beta cell function (%) 100 0 0 –10 –9 –8 –7 –6 –5 –4 –3 –2 –1 Timing to diagnosis (years) 1 2 3 4 5 6 -cell function Insulin resistance HOMA model, diet-treated n = 376 Holman RR et al. Diabetes Res Clin Pract 1998 -cell mass is already impaired at the diagnosis of type 2 diabetes 3 -cell mass (%) 2,5 -50% 2 1,5 -63% 1 0,5 0 NGT IFG Obese Type 2 Diabete diabetes tipo 2 NGT Type 2 Diabete diabetes tipo 2 LADA Lean Butler AE et al. Diabetes 2003; Leslie RD e Pozzilli P, J Clin Endocrinol Metab 2006 Oral hypoglycemic agents targeting the pathophysiologic defects in type 2 diabetes Pancreas Impaired insulin secretion Liver Sulfonylureas Meglitinides DPP-4 inhibitors GLP1 analogues Muscle and fat ↓Glucose level Hepatic glucose overproduction Insulin resistance Gut Metformin TZDs DPP-4 inhibitors GLP1 analogues TZDs Metformin α-Glucosidase inhibitors Metformin Glucose absorption Lifestyle intervention can prevent type 2 diabetes development Trial Da Qing 6 1. Diet 2. Exercise 3. Diet & Exercise RR (95% CI) 0.66 (0.53-0.81) 0.56 (0.44-0.70) 0.49 (0.33-0.73) 522 IGT overweight (Finland) 3.2 Diet & Exercise 0.42 (0.3-0.7) 3,234 IGT (USA) 2 1. Diet & Exercise 2. Metformin 0.42 (0.34-0.52) 0.69 (0.57-0.83) 2.5 1. Diet & Exercise 2. Metformin 3. Metformin + Diet & Exercise 0.72 (0.62-0.80) 0.74 (0.65-0.81) 0.72 (0.62-0.80) n Population 577 IGT (China) DPS DPP IDPP 531 IGT (India) Follow-up (years) Interventions DPS, Finnish Diabetes Prevention Study; DPP, Diabetes Prevention Program; IDPP, Indian Diabetes Prevention Program Incidence of Diabetes in the DPP trial Percent developing diabetes All Placebo (n=1082) Metformin (n=1073, p<0.001 vs. Placebo) Lifestyle (n=1079, p<0.001 vs. Met , p<0.001 vs. Plac ) Lifestyle p<0.001vs.vs. Metformin , Metformin(n=1079, (n=1073, p<0.001 Plac) Placebo (n=1082) p<0.001 vs. Placebo) Cumulative incidence (%) 40 30 participants Risk reduction 31% by metformin 58% by lifestyle 20 10 0 0 1 2 3 4 Years from randomization The DPP Research Group, NEJM 346:393-403, 2002 Pharmacological intervention to prevent type 2 diabetes Trial DPP Subjects Population (n) 3,234 Drug Follow-up (years) RR (95% CI) Weight Adverse events ↓ GI symptoms IGR Metformin overweight (850mg bid) 2.8 0.69 (0.57-0.83) STOP-NIDDM 1,419 IGT Acarbose (100mg tid) 3.9 0.75 (0.63-0.90) GI symptoms Voglibose 1,780 IGT Voglibose (0.2mg tid) 3 0.59 (0.43-0.81) GI symptoms DREAM 5,269 IGR Rosiglitazone (8mg/day) 3 0.40 (0.35-0.46) ↑ Edema ACT-NOW 602 IGT Pioglitazone (30-45mg/day) 2.4 0.28 (0.16-0.49) ↑ Edema, Dyslipidemia XENDOS 3,277 IGT obese Orlistat (120mg tid) 4 0.72 (0.58-0.91) ↓ GI symptoms ORIGIN 1,456 IGR Glargine 6 0.80* (0.64-1.00) ↑ Hypoglycemia * Odds Ratio; IGR, Impaired glucose regulation; GI, Gastro-intestinal. The STOP-NIDDM: Acarbose Acarbose 100 mg TID n=682 Placebo n=686 25% Relative Risk Reduction P=0.0022 Acarbose reduced risk of new • Hypertension >140/90; 5.3% absolute risk reduction (P=0.006) • Myocardial infarction (P=0.02) • Any CVD event: CHD, CV death or stroke, CHF, PVD (P=0.03) Chiasson JL, et al. Lancet. 2002;359(9323): 2072-2077; Chiasson JL, et al. JAMA. 2003;290(4):486-494. ACT NOW: Pioglitazone • Pioglitazone reduced risk of type 2 diabetes by 72% vs. placebo (HR 0.28; 95% CI 0.16–0.49 P<0.001) • Conversion to normal glucose tolerance: 48% of patients with pioglitazone vs 28% with placebo (P<0.001) • Pioglitazone reduced fasting glucose, 2-hour glucose, HbA1c • Weight gain, edema observed in the pioglitazone arm DeFronzo RA, et al, for the ACT NOW Study. N Engl J Med. 2011 ORIGIN: Insulin glargine Gernstein et al. NEJM 2012 Sustained effect of lifestyle intervention Diabetes Prevention Study 3-years post-intervention follow-up Lindstrom J et al. Lancet 2006 DaQing 20-years post-intervention follow-up study Li G et al. Lancet 2008 DPP: Metformin had sustained effect after drug washout • Brief (1-2 week) drug washout study at end of Diabetes Prevention Program trial • After washout, diabetes was more frequently diagnosed in metformin vs. placebo (1.49; 0.93, 2.38; P=0.098) • DPP primary analysis: metformin decreased diabetes risk by 31% • Washout: 26% accounted for by pharmacological effect of metformin • Postwashout: diabetes reduced by 25% Diabetes Prevention Program Research Group. Diabetes Care. 2003;26:977-980. Summary of lifestyle/ pharmacological interventions Lifestyle intervention continues to have an effect; most drugs do not Lifestyle Study Intervention Treatment Risk Reduction 34% - 69% Da Qing IGT 577 Lifestyle 6 years 20 years Finnish DPS IGT 523 Lifestyle 3 years 7 years 58% DPP IGT 3,324 Lifestyle 3 years 58% N Intervention Treatment Risk Reduction Study Pharmacologic N DPP IGT 3,324 Metformin 3 years 31% DREAM IGT 5,269 Rosiglitazone 3 years 60% STOP-NIDDM IGT 1,429 Acarbose 3 years 21% ACT NOW IGT ~600 Pioglitazone 3 years 81% ORIGIN IGR 1,456 Glargine 6 years 20% Dietary intake keep increasing… Grains and fats account for nearly all of the increase in daily calorie consumption since 1970 Daily calorie consumption by food group - US Added fats Flour, cereal products Proteins 2007 1990 1970 Added sugars Dairy Vegetables Fruit 0 100 200 300 400 500 600 700 800 Source: Food and Agriculture Organization of the United Nations … while price of food, adjusted for inflation, has dropped The price of added sugars has dropped significantly more than the price of healthful foods Inflation-Adjusted Cost of One Ton of Various Food -50% Proteins +30% Fruits -38% Fats Vegetables 0% Dairy -38% -29% Grain Sugar -50% 0 500 1,000 1,500 2,000 2,500 3,000 3,500 4,000 Source: USDA's Economic Research Service 2007 1990 1970 Taxing unhealthy food and drinks to improve health? Examples of Health-related food taxes Mytton et al. BMJ 2012 Junk food taxes might reduce energy intake, weight and insulin levels over time 20 years longitudinal study (CARDIA study) on 5,115 young adults * and e, P<0.05 Duffey et al. Arch Intern Med 2010 Financial Incentive–Based Approaches for Weight Loss 57 healthy subject 30-70 years, BMI 30-40, were randomized to 3 weight loss plans: 1) Monthly weigh-ins, 2) LOTTERY incentive program: participants played a lottery and received the earnings if they achieved or lost more than the target weight 3) DEPOSIT incentive: participants invested their own money, which they lost if they failed to achieve weight goals. 16 weeks follow-up The use of economic incentives produced significant weight loss (more than the control group) during the 16 weeks of intervention that was not fully sustained (Volpp et al. JAMA 2008) Change in weight from baseline (lb) Financial incentives for weight loss: group-based incentives are more effective than individual incentives Control group Individual-incentive group* Group-incentive group** Week 105 obese employers (BMI 30-40) randomized to and followed up to 24 weeks: *INDIVIDUAL INCENTIVE: $100 per person per month for meeting or exceeding weight-loss goals **GROUP INCENTIVE: $500 per month split among participants within groups of 5 who met or exceeded weight-loss goals CONTROL GROUP Kullgren et al. Ann Intern Med 2013 Peer mentoring and financial incentives for blood glucose control 118 African Americans veterans assinged to the following three groups and followedup to 6 months: 1) USUAL CARE 2) PEER MENTOR Patients were assigned a mentor who formerly had poor glycemic control but now had good control (HbA1c level 7.5%). The mentor was asked to talk with the patient at least once per week. Peer mentors were matched by race, sex, and age. 3) FINANCIAL INCENTIVES - $100 by decreasing HbA1c by 1% - $200 by decreasing HbA2c by 2% or to an HbA1c 6.5%. Peer mentorship improved glucose control in a cohort of African American veterans with diabetes. (Long et al. Annals of Int Med 2012) Call for Action • We must identify patients at highest risk (prediabetes) • Modest lifestyle changes are most effective • Sustain interventions • Increase opportunities for community programs to support prevention • Delaying or preventing type 2 diabetes is costeffective and will help turn the tide on the diabetes epidemic • “Health-taxes” for improving adherence to healthy lifestyle or reducing calorie intake might be considered A possible approach to tackle the diabetes epidemic Low Adherence Lifestyle intervention Detect and tackle barriers Good Adherence Easy to deliver Sustained effect Low cost Junk food taxes Normal blood glucose “BMI taxes” or “BMI prize” “Blood glucose taxes” or “Blood glucose prize” Obesity Pre-diabetes Lifestyle Genetic background Diabetes