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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 Data) CDC. MMWR Morb Mortal Wkly Rep. 2008;57:1203-1205.

  10. 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.

  11. Prevention of T2DM: Lifestyle ModificationTrials ARR, absolute risk reduction; DPP, Diabetes Prevention Program; DPS, Diabetes Prevention Study; NNT, number needed to treat; RRR, relative risk reduction; T2DM, type 2 diabetes mellitus. Regensteiner JG, et al, eds. Diabetes and Exercise. New York: Humana Press, 2009.

  12. Effect of Lifestyle and Metformin on the Progression From Prediabetes to T2DM Placebo (N=1082) 40 30 20 10 0 Metformin (N=1073, P<0.001 vs. Placebo) Risk Reduction 31% by metformin 58% by lifestyle Cumulative Incidence of Diabetes (%) Lifestyle (N=1079, P<0.001 vs Metformin P<0.001 vs Placebo) 0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 Year Figure 2. Cumulative Incidence of Diabetes According to Study Group. The diagnosis of diabetes was based on the criteria of the American Diabetes Association.11 The incidence of diabetes differed significantly among the 3 groups (P<0.001 for each comparison). T2DM, type 2 diabetes mellitus. Knowler WC, et al. N Engl J Med. 2002;346:393-403.

  13. The Chinese Prevention Study The Effect of Metformin on the Progressionof IGT to Diabetes Mellitus (N=321) RRR=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.

  14. 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.

  15. 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.

  16. 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.

  17. 10-Year Follow-up of T2DM Incidence and Weight Loss in the 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.

  18. 10-Year Follow-up of T2DM Incidence and Weight Loss 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.

  19. 10-Year Follow-up of T2DM Incidence and Weight Loss 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. DPP Year 1: Mean Change in Blood Pressure Systolic Diastolic Baseline BP 124 124 124 79 78 78 Change in BP (mm Hg) BP, blood pressure; DPP, Diabetes Prevention Program. Ratner R, et al. Diabetes Care. 2005;28:888.

  31. * Prevalence of Hypertension (% of patients) Effects of Metformin, Lifestyle Modifications, and Placebo on Hypertension Over 36 Months in DPP P<0.001 P=0.08 P<0.001 DPP, Diabetes Prevention Program; HTN, hypertension. Ratner R, et al. Diabetes Care. 2005;28:888-894.

  32. STOP NIDDM: Incidence of New Cases of Hypertension in IGT Patients 18 16 Hypertension defined as BP 140/90 mmHg Placebo 14 12 10 Cumulative Incidence (%) Acarbose 8 6 4 RRR = 34% P=0.0059 2 0 3 0 1 2 4 5 BP, blood pressure; IGT, impaired glucose tolerance; STOP NIDDM, Study to Prevent Non-Insulin Dependent Diabetes Mellitus Trial Chiasson JL, et al. JAMA. 2003;290:486-494. Years After Randomization

  33. DPP Study: Mean Change in Total and LDL Cholesterol Total Cholesterol LDL-C Baseline (mg/dL) 202 127 Change in Lipids(%) DPP, Diabetes Prevention Program; LDL-C, low-density lipoprotein. DPP Research Group. Diabetes Care. 2005;28:2472–2479. Ratner R, et al. Diabetes Care. 2005;28:888-894.

  34. DPP Study: Mean Change in Triglycerides and HDL Cholesterol Triglycerides HDL-C Baseline (mg/dL) 172 40 Change in Lipids(mg/dL) DPP, Diabetes Prevention Program. DPP Research Group. Diabetes Care. 2005;28:2472–2479. Ratner R, et al. Diabetes Care. 2005;28:888-894.

  35. DPP Study: Effects of Metformin, Lifestyle Modifications, and Placebo on Lipids: 3-year Timeframe DPP, Diabetes Prevention Program. Ratner R, et al. Diabetes Care. 2005;28:888-894.

  36. CVD Outcomes in Type 2 Diabetes Prevention Trials CVD, cardiovascular disease; DPP, Diabetes Prevention Program; DREAM, Diabetes Reduction Assessment with Ramipril and RosiglitazoneMedication; STOP NIDDM, Study to Prevent Non-Insulin Dependent Diabetes Mellitus Trial. Ratner R, et al. Diabetes Care. 2005;28:888-894. DREAM Investigators. Diabetes Care. 2008;31:1007-1014. Chiasson JL, et al. JAMA. 2003;290:486-494.

  37. STOP-NIDDM Study: Effect of Acarbose on Cardiovascular Event Incidence in Patients With IGT 5 47 subjects with CVD events 32 placebo 15 acarbose Placebo 4 RRR = 49% P=.03 3 Cumulative Incidence (%) 2 Acarbose 1 0 0 1 2 3 4 5 Years After Randomization CVD, cardiovascular disease; IGT, impaired glucose tolerance; RRR, relative risk reduction; STOP NIDDM, Study to Prevent Non-Insulin Dependent Diabetes Mellitus Trial. Chiasson JL, et al. JAMA. 2003;290:486-494.

  38. STOP NIDDM CVD Events CVD, cardiovascular disease; STOP NIDDM, Study to Prevent Non-Insulin Dependent. Chiasson JL, et al. JAMA. 2003;290:486-494.

  39. Cumulative Incidence of CVD Death During Follow-up in China Da Qing Diabetes Prevention Study  Control Intervention CVD, cardiovascular disease. Li G, et al. Lancet. 2008;371:1783-1789.

  40. Pharmacotherapy for Cardiovascular Risk Factors ACE, angiotensin converting enzyme; LDL, low-density lipoprotein. Handelsman Y, et al. EndocrPract. 2011;17(suppl 2):1-53. Garber AJ, et al. Endocr Pract. 2008;14:933-946.

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