1. The Diabetes Prevention Program A U.S. Randomized Clinical Trial to Prevent Type 2 Diabetes in Persons at High Risk

2. Overview Briefly review the background and results of the DPP studyBriefly review the background and results of the DPP study Reminder: we are not repeating the DPP study!Reminder: we are not repeating the DPP study! IHS Competitive Grant ProgramIHS Competitive Grant Program –Diabetes Prevention Demonstration Project –Demonstrate that diabetes prevention activities can be successfully implemented in Indian health programs

3.  To prevent or slow the development of type 2 diabetes in persons with impaired glucose tolerance (IGT) Pre-diabetes ---X---> Diabetes? DPP Primary Goal DPP Primary Goal

4. Study Interventions Eligible participants (IGT) Randomized IntensiveLifestyle (n = 1079) Metformin (n = 1073) Placebo (n = 1082)

5. Outcomes Percent of people with pre-diabetes who develop diabetes over timePercent of people with pre-diabetes who develop diabetes over time Physical activity / nutritionPhysical activity / nutrition Body weight and fat distributionBody weight and fat distribution Many other outcomes measuredMany other outcomes measured

6. Diabetes Prevention Program Clinics..........................

7. Age > 25 yearsAge > 25 years Individuals with IGT (Pre-diabetes)Individuals with IGT (Pre-diabetes) –2 hour glucose 140-199 mg/dl (7.8- <11.1mmol/L) and –Fasting glucose 95-125 mg/dl (5.3- <7.0 mmol/L) Body mass index (BMI) > 24 kg/m 2Body mass index (BMI) > 24 kg/m 2 All ethnic groupsAll ethnic groups goal of up to 50% from high risk populations n = 3234 participantsn = 3234 participants Eligibility criteria

8. Study Population Caucasian 1768 (55%) 1768 (55%) AfricanAmerican 645 (20%) HispanicAmerican 508 (16%) Asian/Pacific Islander 142 (4%) 142 (4%) American Indian 171 (5%) 171 (5%)

9. Study Participants Gender DistributionAge Distribution 25-44 31% > 60 20% 45-59 49% Men 32% Women 68%

10. Lifestyle Intervention An intensive program with the following specific goals: An intensive program with the following specific goals: > 7% loss of body weight and maintenance of weight loss> 7% loss of body weight and maintenance of weight loss - Fat gram goal -- 25% of calories from fat - Calorie intake goal -- 1200-1800 kcal/day > 150 minutes per week of physical activity> 150 minutes per week of physical activity - 30 minutes, 5 days a week

11. Lifestyle Intervention Structure Lifestyle Intervention Structure 16 session core curriculum (over 24 weeks)16 session core curriculum (over 24 weeks) –Education and training in diet and exercise methods and behavior modification skills, self monitoring techniques, problem solving, empowerment, and social support –Frequent contact with case manager and DPP support staff Monthly visitsMonthly visits Periodic group classes and motivational campaignsPeriodic group classes and motivational campaigns Tool box strategiesTool box strategies Long-term maintenance programLong-term maintenance program

12. Mean Weight Change 0 6 12 18 24 30 36 42 48 Months Lifestyle Metformin + Placebo

13. 0 1 2 3 4 Years from randomization Mean change in leisure physical activity (Met hours per week) Lifestyle Metformin Placebo

14. 0 1 2 3 4 0 10 20 30 40 Percent developing diabetes All participants Years from randomization Cumulative incidence (%) Lifestyle Metformin Placebo

15. Development of Diabetes Development of Diabetes Placebo Metformin Life-style Placebo Metformin Life-style Development of diabetes 11.0% 7.8% 4.8% (percent per year) (percent per year) Reduction of diabetes ---- 31% 58% compared with placebo compared with placebo

16. Diabetes incidence rates by race - ethnicity

17. Summary Intensive life-style intervention reduced the development of diabetes by 58%Intensive life-style intervention reduced the development of diabetes by 58% Metformin reduced the development of diabetes by 31%Metformin reduced the development of diabetes by 31% Life-style was more effective than metforminLife-style was more effective than metformin

18. Summary Intensive life-style achieved weight loss and increased activity level that were sustained for the duration of the studyIntensive life-style achieved weight loss and increased activity level that were sustained for the duration of the study Both interventions were effective regardless of gender or raceBoth interventions were effective regardless of gender or race Intensive life-style intervention was effective in all age groups, particularly in those aged 60 and olderIntensive life-style intervention was effective in all age groups, particularly in those aged 60 and older