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Beyond the DPP: The Diabetes Prevention Program Outcomes Study

Beyond the DPP: The Diabetes Prevention Program Outcomes Study. William C. Knowler, MD, DrPH NIDDK, Phoenix Tribal Leaders Diabetes Committee Albuquerque March 10, 2003. DPP: A Three-Way Partnership Between Tribes, NIDDK, I.H.S. Pilot study of lifestyle interventions:

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Beyond the DPP: The Diabetes Prevention Program Outcomes Study

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  1. Beyond the DPP:The Diabetes Prevention Program Outcomes Study William C. Knowler, MD, DrPH NIDDK, Phoenix Tribal Leaders Diabetes Committee Albuquerque March 10, 2003

  2. DPP: A Three-Way Partnership Between Tribes, NIDDK, I.H.S. • Pilot study of lifestyle interventions: • Gila River Indian Community & NIDDK, 1992-94 • DPP planning phase 1994-96 • Primary funding by NIDDK • I.H.S. representative on Steering Committee • AZ-NM tribes communications committee • DPP main phase 1996-2001 • Primary funding by NIDDK • I.H.S. provided funds, physicians, clinic space, lab support • Salt River Indian Community provided space & utilities

  3. Sharing Study Progress • Quarterly newsletters to participants • Annual presentations to tribal councils, health departments, or review boards

  4. Mean Weight Change in the DPP Placebo Metformin Lifestyle NEJM, 2002

  5. Diabetes Incidence Rates by Ethnicity The DPP Research Group, NEJM 346:393-403, 2002

  6. Main Results Announced August 2001 • DPP staff informed of results & early termination • Participants informed: detailed data presentation • Tribal Councils and health departments • National press conference • All this within 1 week • Presentations to tribal health departments & programs • Distribute copies of research articles

  7. Main Results Announced August 2001:What Next? • Obligation to DPP participants • Provide the best interventions • Long-term help • Obligation to tribes (participating & others) • Informing of results • Assistance with implementation • Staff training • Further medical research questions

  8. Provide the Best Interventions • Group-implemented Lifestyle Intervention • Provide to all participants • Group rather than individual sessions • Metformin • Did not work as well as ILS • Still not approved for prevention • Continue in those taking it • Others to see their physician if they want it

  9. DPPOS Study Questions:Long-term Effects of DPP Interventions on • Weight loss maintenance • Development of diabetes • Eye, kidney, nerve complications of diabetes • Cardiovascular disease and death

  10. DPPOS Outcomes - 1 • Maintenance of weight loss • New cases of diabetes- as in DPP

  11. DPPOS Outcomes - 2 • Diabetes-related complications • Microvascular and nerve complications • Retinopathy • Neuropathy • Renal dysfunction • Abnormal albuminuria • ESRD or abnormal serum creatinine • Cardiovascular • CVD events (fatal and non-fatal MI or stroke) • Silent MI (EKG) • Atherosclerosis in the neck arteries (ultrasound) • Blood vessel disease in legs • Cardiovascular disease risk factors

  12. Intervention Phases Placebo Metformin ILS DPP Bridge: 6 mo DPPOS 2.8 years average intervention 1996-2001 2002 2003-2007+ Group implemented life-style modification Group LS Met+Group LS Booster LS 5 year follow-up Group LS: quarterly group meetings to reinforce LS modification Booster LS: two four week “booster sessions” per year Metformin: 850 mg twice per day

  13. Implementation of FindingsDPP Staff Priorities • DPP participants • Participating tribes • Other tribes and I.H.S.

  14. Implementation of FindingsDPP Staff Activities • Present results at local & national meetings • “Message of Hope” video and other materials • Designed and “played” by participants, community leaders • Widely distributed • Health for Native Life magazine article • Train Navajo Nation health staff in ILS manual (Farmington, NM, Sept. 2002) • Train Albuquerque Area I.H.S. staff in ILS manual (Albuquerque, NM, May 2003)

  15. How to Do It in Your Community • Identify as a priority • Allocate staff time (8 hrs/class) • Staff need training & professional support • Provide tools (tracking books, scales, measuring cups) • Plan for it when budgeting

  16. Conclusions:DPP Outcomes Study • Continue beneficial interventions • Determine long-term effectiveness on • Development of diabetes • Prevention of complications

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