The Diabetes Prevention Program Outcomes Study Longterm Followup

The Diabetes Prevention Program Outcomes Study: Long-term Follow-up to A Randomized Clinical Trial to Prevent Type 2 Diabetes in Persons at High Risk The DPP/DPPOS Research Group NNHRRB Conference November 2011

Sponsors • National Institute of Diabetes & Digestive & Kidney Diseases • Other NIH Institutes, Offices National Center on Minority Health and Health Disparities National Institute of Child Health and Human Development National Institute on Aging National Center for Research Resources, GCRC Program Office of Research on Women’s Health National Eye Institute National Heart Lung and Blood Institute • Indian Health Service • Centers for Disease Control and Prevention

. Diabetes Prevention Program Outcomes Study Clinics . .

Study Timeline

DPP Primary Goal 1996 -2002: To prevent or delay the development of type 2 diabetes in persons with impaired glucose tolerance (IGT) DPPOS Primary Goal 2002 -2013: Prevention of diabetes complications such as kidney, eye and nerve problems, and heart disease

Who Joined DPP? Screen (158, 177 people) Randomize (3, 819 people) Standard lifestyle teaching Intensive Lifestyle (1079 people) Metformin (1073 people) Placebo (1082 people) Troglitazone 585 people Until 6/98

Who Joined DPPOS? • 3251 of the original 3819 DPP participants joined DPPOS. • 88% of the original DPP participants.

Who Joined DPPOS at Shiprock ? • 74 DPP participants joined DPPOS. • 93% of the original Shiprock DPP participants. • Shiprock participants are great!

DPP Treatments • Lifestyle Goals – 7% weight loss – 150 minutes activity each week • Metformin Goals -850 mg twice daily

DPPOS Treatments • Original Placebo group – HELP classes four times a year • Original Metformin group – Metformin 850 mg twice daily – HELP classes four times a year • Original Lifestyle group – HELP classes four times a year – Boost lifestyle classes twice a year

How Many Calories and Fat grams in a Navajo Taco?

Fat and Calories in Navajo Taco Fat grams Calories Fry bread 8 inches 14 555 Pinto beans with hamburger 1 cup Lettuce 1/2 cup 10 370 0 4 Tomatoes 1/2 cup 0 19 Onion 1/4 cup 0 15 Cheese 1/4 cup 9 114 Salsa 2 Tablespoons 0 8 33 1, 085 TOTAL

Fat and Calories in Healthier Navajo Taco Fat grams Calories 11 415 Pinto beans without hamburger 1 cup Lettuce 1/2 cup 2 258 0 4 Tomatoes 1/2 cup 0 19 Onion 1/4 cup 0 15 4. 5 57 0 8 17. 5 776 Fry bread 6 inches Cheese 2 T. Salsa 2 Tablespoons TOTAL

DPPOS Incidence of Diabetes

DPP vs. DPPOS Diabetes Rates Crude Rate per 100 PYR 12 Placebo Metformin 10 8 6 4 2 0 DPP (n=3234) DPPOS (n=1994)

Diabetes Development in DPPOS • Original Lifestyle participants continue to develop diabetes at the lower rate they developed diabetes during DPP. • Original Placebo and Metformin participants have lowered their rate of diabetes development to a similar rate as the Lifestyle group.

Weight Change Over Time

Keys to DPP Lifestyle Success • Weight loss was the key to diabetes prevention -Every 2. 2 pounds of weight loss decreased risk by 13% • Reduction of total calories, especially fat calories -At baseline, American Indians reported 37. 5% calories from fat • Achieving 150 minutes of activity each week • DPP intervention was key to prevention

Metformin in DPP • Most effective in DPP participants: – BMI >35 – Age 25 -44 years • Little risk reduction in DPP participants : – BMI 24 -30 – Age ≥ 60 years

DPPOS Diabetes Risk Reduction • Delay in diabetes onset after 10 years follow-up: – 4 years for Lifestyle – 2 years for Metformin • The lower rate of diabetes development for lifestyle and metformin during DPP means: – Original Lifestyle participants have a 34% lower risk of diabetes compared to Placebo – Original Metformin participants have a 18% lower risk of diabetes compared to Placebo

Diabetes Frequency After 10 years • 52% of Placebo participants have diabetes • 47% of Metformin participants have diabetes • 42% of Lifestyle participants have diabetes

Cost Effectiveness Herman ADA Oral Presentation June 2011 • Over 10 years, metformin treatment reduced the costs of medical care by $1700 person • Over 10 years lifestyle treatment reduced the costs of medical care by $2600 person • Since lifestyle costs more to administer, the reductions make metformin treatment cost saving and lifestyle remains cost effective

‘This puts diabetes prevention in the category of prenatal care or pediatric immunizations, said Herman. It’s dramatic when an intervention can improve the health of the population and potentially save money at the same time. ’

What’s Next for DPPOS? • Data collection, metformin and lifestyle according to DPP treatment assignment. • Next evaluation of study progress will be in 2013.

Thank You to all DPPOS participants for their Contributions to Diabetes Research and Prevention Their Contributions Carry On through you!