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Prediabetes

Prediabetes. Management. AACE Prediabetes Consensus Statement: Summary. Untreated individuals with prediabetes are at increased risk for diabetes as well as for micro- and macrovascular complications

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Prediabetes

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  1. Prediabetes Management

  2. AACE Prediabetes Consensus Statement: Summary • Untreated individuals with prediabetes are at increased risk for diabetes as well as for micro- and macrovascular complications • Treatment goals are to prevent deterioration in glucose levels and modify other risk factors such as obesity, hypertension, and dyslipidemia • The same blood pressure and lipid goals are suggested for prediabetes and diabetes • Intensive lifestyle management is the cornerstone of all prevention efforts; pharmacotherapy targeted at glucose may be considered in high-risk patients Handelsman Y, et al. Endocr Pract. 2011;17(Suppl 2):1-53. Garber AJ, et al. Endocr Pract. 2008;14:933-946.

  3. Prediabetes • Epidemiologic evidence suggests that the complications of T2DM begin early in the progression from NGT to frank diabetes • Prediabetes and diabetes are conditions in which early detection is appropriate, because • Duration of hyperglycemia is a predictor of adverse outcomes • There are effective interventions to prevent disease progression and to reduce complications NGT, normal glucose tolerance ; T2DM , type 2 diabetes mellitus. Garber AJ, et al. Endocr Pract. 2008;14:933-946.

  4. Policy Paradigm Shifts Needed to Stem Global Tide of T2DM • Integrating primary and secondary prevention along a clinical continuum • Early detection of prediabetes and undiagnosed diabetes • Implementing cost-effective prevention and control by integrating community and clinical expertise/resources within affordable service delivery systems • Sharing and adopting evidence-based policies at the global level T2DM , type 2 diabetes mellitus. NarayanKM, et al. Health Aff (Millwood). 2012;31:84-92.

  5. Feasibility of Preventing T2DM • There is a long period of glucose intolerance that precedes the development of diabetes • Screening tests can identify persons at high risk • There are safe, potentially effective interventions that can address modifiable risk factors: • Obesity • Body fat distribution • Physical inactivity • High blood glucose T2DM, type 2 diabetes mellitus. Garber AJ, et al. Endocr Pract. 2008;14:933-946.

  6. Interventions to Reduce Risks Associated With Prediabetes • Therapeutic lifestyle management is the cornerstone of all prevention efforts • No pharmacologic agents are currently approved for the management of prediabetes • Pharmacotherapy targeted at glucose may be considered in high-risk patients after individual risk-benefit analysis Garber AJ, et al. Endocr Pract. 2008;14:933-946.

  7. Lifestyle Intervention in Prediabetes Garber AJ, et al. Endocr Pract. 2008;14:933-946.

  8. Primary Care-Based Counseling for T2DM Prevention: ADAPT ADAPT, Avoiding Diabetes Thru Action Plan Targeting; T2DM , type 2 diabetes mellitus. Mann DM, Lin JJ. ImplementSci. 2012;23:6.

  9. Self-Reported Risk Reduction Activities in Patients With Prediabetes National Health and Nutrition Examination Survey Patients CDC. MMWR Morb Mortal Wkly Rep. 2008;57:1203-1205.

  10. Prediabetes Management Prevention of Diabetes: Lifestyle Studies

  11. Prevention of T2DM: Selected Lifestyle Modification Trials BMI, body mass index; NNT, number needed to treat; RRR, relative risk reduction; T2DM, type 2 diabetes mellitus. DPP Research Group. N Engl J Med. 2002;346:393-403. Eriksson J, et al. Diabetologia. 1999;42:793-801.Li G, et al. Lancet. 2008;371:1783-1789. Lindstrom J, et al. Lancet. 2006;368:1673-1679.

  12. T2DM Incidence in theDiabetes Prevention Program 31% 58% T2DM incidence per 100 person-years Metformin850mg BID (n=1073) Placebo (n=1082) Intensive lifestyle intervention* (n=1079) *Goal: 7% reduction in baseline body weight through low-calorie, low-fat diet and ≥150 min/week moderate intensity exercise. IGT, impaired glucose tolerance; T2DM, type 2 diabetes mellitus. DPP Research Group. N Engl J Med. 2002;346:393-403.

  13. Effect of Age on Incidence of T2DM in the DPP 48% T2DM incidence per 100 person-years 59% 71% Age (years) *Goal: 7% reduction in baseline body weight through low-calorie, low-fat dietand ≥150 min/week moderate intensity exercise. DPP, Diabetes Prevention Program;. DPP Research Group. N Engl J Med. 2002;346:393-403.

  14. Effect of Weight on T2DM Incidence in the DPP 51% T2DM incidence per 100 person-years 61% 65% BMI (kg/m2) *Goal: 7% reduction in baseline body weight through low-calorie, low-fat dietand ≥150 min/week moderate intensity exercise. DPP, Diabetes Prevention Program. DPP Research Group. N Engl J Med. 2002;346:393-403.

  15. 10-Year Weight Loss inthe DPP Outcomes Study 4 5 6 7 0 1 2 3 8 9 10 Years DPP, Diabetes Prevention Program; T2DM, type 2 diabetes mellitus. DPP Research Group. Lancet. 2009;374:1677-1686.

  16. 10-Year Incidence of T2DM in the DPP Outcomes Study Placebo Metformin Lifestyle 4 5 6 7 0 1 2 3 8 9 10 Years DPP, Diabetes Prevention Program; T2DM, type 2 diabetes mellitus. DPP Research Group. Lancet. 2009;374:1677-1686.

  17. 10-Year Incidence of T2DM in the DPP Outcomes Study DPP, Diabetes Prevention Program; DPPOS, Diabetes Prevention Program Outcomes Study; T2DM, type 2 diabetes mellitus. DPP Research Group. Lancet. 2009;374:1677-1686.

  18. T2DM Prevention in Women With a History of GDM: Effect of Metformin and Lifestyle Interventions • Findings from the DPP: • Progression to diabetes is more common in women with a history of GDM vs those without, despite equivalent degrees of IGT at baseline • Both intensive lifestyle and metformin are highly effective in delaying or preventing diabetes in women with IGT and a history of GDM DPP, Diabetes Prevention Program; GDM, gestational diabetes mellitus; IGT, impaired glucose tolerance; T2DM, type 2 diabetes mellitus. Ratner RE, et al. J Clin Endocrinol Metab. 2008;93:4774-4779.

  19. T2DM Prevention in Women With a History of GDM: Effect of Metformin and Lifestyle Interventions • Findings from the DPP: • Progression to diabetes is more common in women with a history of GDM vs those without, despite equivalent degrees of IGT at baseline • Both intensive lifestyle and metformin are highly effective in delaying or preventing diabetes in women with IGT and a history of GDM DPP, Diabetes Prevention Program; GDM, gestational diabetes mellitus; IGT, impaired glucose tolerance; T2DM, type 2 diabetes mellitus. Ratner RE, et al. J Clin Endocrinol Metab. 2008;93:4774-4779.

  20. The Finnish Diabetes PreventionStudy: Lifestyle Modifications Change from baseline P<0.001 P<0.001 P=0.02 P=0.007 DBP, diastolic blood pressure; SBP, systolic blood pressure. Tuomilehto J, et al. N Engl J Med. 2001;344:1343-1350.

  21. The Finnish Diabetes Prevention Study: Lifestyle Modifications P<0.001 Change from baseline P=0.003 P=0.001 (g/mL) (mg/dL) (mg/dL) (mg/mL) DBP, diastolic blood pressure; SBP, systolic blood pressure. Tuomilehto J, et al. N Engl J Med. 2001;344:1343-1350.

  22. The Finnish Diabetes Prevention Study: Cumulative Incidence of Diabetes Over 4 Years 58% Incidence of diabetes (cases/1000 person-years) DBP, diastolic blood pressure; SBP, systolic blood pressure. Tuomilehto J, et al. N Engl J Med. 2001;344:1343-1350.

  23. Da Qing: Cumulative Incidence of Diabetes at 6-Year Evaluation Patients with IGT (N=577) Patients with T2DM at Year 6 (%) IGT, impaired glucose tolerance. Pan XR, et al. Diabetes Care. 1997;20:537-544.

  24. Cumulative T2DM Incidence During Follow-up in the Chinese Da Qing Diabetes Prevention Study CI, confidence interval; DPP, Diabetes Prevention Program; T2DM, type 2 diabetes mellitus. Li G, et al. Lancet. 2008;371:1783-1789.

  25. Group Lifestyle Balance Program Intervention University of Pittsburgh Primary Care Practice and Diabetes Prevention Support Center   • DPP lifestyle intervention was adapted to a 12-session group-based program • Implemented in a community setting in 2 phases using a nonrandomized prospective design • Significant decreases in weight, waist circumference, and BMI were noted in both phases vs baseline • Average combined weight loss for both groups over the 3-month intervention was 7.4 pounds (3.5% relative loss, P<0.001) DPP, Diabetes Prevention Program; mo, month. Kramer MK, et al. Am J Prev Med. 2009;37:505-511.

  26. Translating the DPP Into Community Intervention The DEPLOY Pilot Study • Pilot, cluster-randomized trial • Group-based DPP lifestyle intervention vs brief counseling alone (control) among high-risk adults who attended a diabetes risk-screening event at one of two semi-urban YMCA facilities P=0.002 P<0.001 DEPLOY, Diabetes Education & Prevention with a Lifestyle Intervention Offered at the YMCA; DPP, Diabetes Prevention Program; YMCA, Young Men’s Christian Association. Ackermann RT, et al. Am J Prev Med. 2008;35:357-363.

  27. Montana CVD and DPP Mean weight and physical activity min/week among participants by lifestyle intervention session CVD, cardiovascular disease; DPP, Diabetes Prevention Program. Amundson HA, et al. Diabetes Educ. 2009;35:209-223.

  28. Translation of the DPP’s Lifestyle Intervention • Four additional studies utilizing the DPP lifestyle interventions in community settings provided the following findings: • Promising evidence of the prevention of diabetes by significantly decreasing glucose levels and adiposity • Statistically significant improvements in many behavioral outcomes and anthropometrics, particularly at 6 months • Decreased fasting glucose and weight in at-risk African Americans • Approaches that improve recruitment of participants from underserved communities into research, especially research related to chronic disease risk factors DPP, Diabetes Prevention Program. Boltri JM, et al. J Natl Med Assoc. 2011;103:194-202. Katula JA, et al. Diabetes Care. 2011;34:1451-1457. Ruggiero L, et al. Diabetes Educ. 2011;37:564-572. Santoyo-Olsson J, et al. Gerontologist. 2011;51(Suppl 1):S82-93.

  29. Prediabetes Management Prevention of Diabetes: Pharmacotherapy Studies

  30. Pharmacologic Interventions Proven to Delay or Prevent T2DM Development T2DM, type 2 diabetes mellitus. Sherwin RS, et al. Diabetes Care. 2004;27,(Suppl 1): S47-S54. Eriksson K-F, Lindgärde F. Diabetologia. 1991;34:891-898. Ramachandran A, et al. Diabetologia 2006;49:289-297. Knowler WC, et al. N Engl J Med. 2002;346:393-403. Defronzo RA, et al. N Engl J Med. 2011;364:1104-15.

  31. The Chinese Prevention Study The Effect of Metformin on the Progressionof IGT to Diabetes Mellitus (N=321) 65% Incidence of Diabetes (%/yr) Control Metformin IGT, impaired glucose tolerance; RRR, relative risk reduction. Yang W, et al. Chin J EndocrinolMetab. 2001;17:131-136.

  32. Effect of Lifestyle Modification and Metformin on Cumulative Diabetes IncidenceThe Indian DPP (N=531) RRR (%) 26.4 P=0.029 28.2 P=0.022 28.5 P=0.018 Incidence (%) n=129 n=133 n=136 n=133 Control LSM MET LSM & MET DPP, Diabetes Prevention Program; LSM, lifestyle modification; MET, metformin; RRR, relative risk reduction. Ramachandran A, et al. Diabetologia 2006;49:289-297.

  33. Effect of Acarbose on Reversion of IGT to NGT The Study to Prevent Non-Insulin Dependent Diabetes Mellitus (STOP-NIDDM) P<0.0001 n=241 (35.3%) Number of Patients n=212 (30.9%) Acarbose Placebo IGT, impaired glucose tolerance; NGT, normal glucose tolerance. Chiasson JL, et al. Lancet. 2002;359:2072-2077.

  34. 60% Rosiglitazone DREAM: Rosiglitazone and New-Onset Diabetes or Death 0.6 Placebo 0.5 0.4 Cumulative hazard rate 0.3 0.2 0.1 0.0 0 1 2 3 4 Follow-up (years) No. at riskPlaceboRosiglitazone 26342635 24702538 21502414 11481310 177217 DREAM Trial Investigators. Lancet. 2006;368:1096-1105.

  35. Pioglitazone for T2DM Prevention in IGT: ACT NOW Kaplan–Meier plot of hazard ratios for time to development of T2DM ACT NOW, ActosNOW for the Prevention of Diabetes; IGT, impaired glucose tolerance; T2DM, type 2 diabetes mellitus. Defronzo RA, et al. N Engl J Med. 2011;364:1104-1115.

  36. Special Concerns for Thiazolidinedione Use in Patients With Prediabetes • Because of concerns about long-term safety, use of thiazolidinediones should be reserved for higher risk populations and those failing other, lower-risk strategies Garber AJ, et al. Endocr Pract. 2008;14:933-946.

  37. Effects of Exenatide and Lifestyle Modification on Body Weight and Glucose Tolerancein Obese Patients With and Without Prediabetes • Patients • N=152, weight 108.6 +/- 23.0 kg, BMI 39.6 +/- 7.0 kg/m2 (IGT or IFG 25%) • Design • 24-week randomized controlled trial: exenatide or placebo plus lifestyle intervention • Results: • Exenatide-treated patients lost 5.1 kg from baseline vs 1.6 kg with placebo (P<0.001) • Both groups reduced their daily caloric intake • IGT or IFG normalized at end point in 77% and 56% of exenatide and placebo subjects, respectively BMI, body mass index; IFG, impaired fasting glucose; IGT, impaired glucose tolerance. Rosenstock J, et al.Diabetes Care. 2010;33:1173-1175.

  38. Medical Weight-Loss Strategies • Orlistat may prevent progression from prediabetes to diabetes • Lorcaserin, a selective serotonin 2C agonist, is indicated for use in obese patients with at least 1 weight-related comorbid condition (eg, hypertension, dyslipidemia, CVD, glucose intolerance, sleep apnea) • Low-dose, immediate-release phentermine and controlled-release topiramate is recommended for obese or overweight patients with weight-related comorbidities such as hypertension, T2DM, dyslipidemia, or central adiposity CVD, cardiovascular disease; obese, BMI ≥30 kg/m2; overweight, BMI ≥27 kg/m2; T2DM, type 2 diabetes mellitus. Garber AJ, et al. Endocr Pract. 2008;14:933-946.

  39. Pharmacologic Weight-Loss Strategies LOCF, last observation carried forward. Orlistat [package insert]. South San Francisco CA; Genentech USA; 2010. Belviq [package insert]. Woodcliff Lake, NJ; Eisai Inc.; 2012. Qsymia [package insert]. Mountain View, CA; VIVUS , Inc; 2012.

  40. Phentermine/Topiramate and Prevention of Type 2 Diabetes 76.6% 48.6% 88.6% 79.7% Annualized incidence of T2DM Garvey TW, et al. Diabetes Care. 2014;37:912-921.

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