protocol diabetes prevention program (dppos) 2017-08-23آ  the diabetes prevention program (dpp,...

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  • Version 4.2 May 1, 2016

    PROTOCOL

    for the

    DIABETES PREVENTION PROGRAM OUTCOMES STUDY

    (DPPOS)

    ClinicalTrials.gov # NCT00038727

    Diabetes Prevention Program Research Group

    Date: May 1, 2016

    Version 4.2

    Version 1.0 May 30, 2002 Version 1.1 October 8, 2002

    Version 2.0 November 18, 2004 Version 2.1 July 5, 2006

    Version 3.0 February 2, 2009 Version 3.1 April 20, 2011 Version 3.2 June 25, 2012

    Version 3.3 February 11, 2013 Version 3.4 March 1, 2014 Version 4.0 March 1, 2015 Version 4.1 March 1, 2016

    Distributed by the DPPOS Coordinating Center Located at

    The Biostatistics Center The George Washington University

    6110 Executive Boulevard, Suite 750 Rockville, Maryland 20852

  • Version 4.2 May 1, 2016

    Table of Contents 1. EXECUTIVE SUMMARY .................................................................................................. 4

    1.1. Background ............................................................................................................................ 4 1.2. Objectives ............................................................................................................................... 7 1.3. Study Population .................................................................................................................... 7 1.4. Study Interventions ................................................................................................................ 7 1.5. Outcomes ................................................................................................................................ 8 1.6. Design and Power ................................................................................................................... 9 1.7. Analyses ............................................................................................................................... 10

    2. OBJECTIVES..................................................................................................................... 11 2.1. Primary ................................................................................................................................. 11 2.2. Secondary ............................................................................................................................. 11 2.3. Other Objectives ................................................................................................................... 12

    3. BACKGROUND AND RATIONALE .............................................................................. 13 3.1. The Diabetes Prevention Program (1996-2001) ................................................................... 13

    3.1.1. DPP Study Rationale and Design .......................................................................................... 13 3.1.2. DPP Study Cohort ................................................................................................................. 14 3.1.3. DPP Outcome Data ............................................................................................................... 14 3.1.4. DPP Study Results ................................................................................................................. 16 3.1.5. Bridge Period Between End of Masked Intervention and Initiation of DPPOS (2002) ......... 16

    3.2. The Diabetes Prevention Program Outcomes Study Phases 1&2 (DPPOS) (2002 – 2015) . 17 3.2.1. DPPOS Study Rationale and Design ..................................................................................... 17 3.2.2. DPPOS Study Cohort ............................................................................................................ 17 3.2.3. DPPOS Phase 1 Results: Diabetes Prevention ..................................................................... 18 3.2.4. DPPOS Phase 2 Results: Impact of DPP Interventions on Microvascular Disease ............. 19 3.2.5. DPPOS Phase 1 & 2 Results: Impact of DPP Interventions on Cardiovascular Disease

    (CVD) Risk ........................................................................................................................... 20 3.3. DPPOS Phase 3 (2015-2026) ............................................................................................... 21

    3.3.1. DPPOS Phase 3: Effects of metformin on CVD .................................................................... 22 3.3.2. DPPOS Phase 3: Impact of DPP Interventions on Cancer ................................................... 23 3.3.3. DPPOS Phase 3: Diabetes Outcomes ................................................................................... 24 3.3.4. DPPOS Phase 3: Effects of Interventions on Microvascular Disease ................................... 24 3.3.5. DPPOS Phase 3: Epidemiology of Microvascular Disease and Neuropathy in IGT and New-

    onset Type 2 Diabetes........................................................................................................... 24 3.3.6. DPPOS Phase 3: Epidemiology of CVD in IGT and New-onset Type 2 Diabetes ................ 25

    3.4. Other important DPP/DPPOS Analyses ............................................................................... 27 3.4.1. Economic Implications .......................................................................................................... 27

    3.5. Effects of Race-ethnicity and Sex ........................................................................................ 27 3.5.1. Risk Factors for Type 2 Diabetes and Diabetes-related Complications in Minority

    Populations .......................................................................................................................... 28

    4. DEFINITION OF OUTCOMES ....................................................................................... 30 4.1. Primary Outcomes during DPP and DPPOS ........................................................................ 30

    4.1.1. Diabetes and Glycemia: OGTT and FPG ............................................................................. 30 4.1.2. Composite Diabetes-related Microangiopathic and Neuropathic Outcome ......................... 31 4.1.3. Cardiovascular Disease ........................................................................................................ 32 4.1.4. Cancer ................................................................................................................................... 32 4.1.5. Determining Vital Status and Cause of Death for Participants............................................. 32 4.1.6. Medicare database ................................................................................................................ 33

    4.2. Other Secondary Outcomes .................................................................................................. 33 4.2.1. Glycemia and insulin secretion: ............................................................................................ 33 4.2.2. Cardiovascular disease and risks, assessed by: .................................................................... 33

    The Biostatistics Center, George Washington University Rockville, Maryland

    1

  • Version 4.2 May 1, 2016

    4.2.3. Retinopathy, assessed by: ...................................................................................................... 34 4.2.4. Nephropathy, assessed by: .................................................................................................... 34 4.2.5. Neuropathy, assessed by: ...................................................................................................... 34 4.2.6. Physical activity, nutrition, behavioral measurements, and body weight and obesity,

    assessed by: .......................................................................................................................... 34 4.2.7. Health related quality of life, assessed by: ............................................................................ 34 4.2.8. Resource Utilization, Costs, Health Utilities, and Effectiveness of treatments ..................... 35 4.2.9. Safety tests: ............................................................................................................................ 35 4.2.10. Serologic evidence of type 1 diabetes, assessed by: .............................................................. 35 4.2.11. Stored specimens: .................................................................................................................. 35 4.2.12. Other chemistries: ................................................................................................................. 35

    5. STUDY DESIGN ................................................................................................................ 36 5.1. Overall Design...................................................................................................................... 36 5.2. Participation Criteria ............................................................................................................ 37 5.3. Procedures for obtaining surrogate consent for future participation .................................... 37 5.4. Principles Guiding the Selection of a Study-wide Group Lifestyle Intervention ................. 37 5.5. Masking ................................................................................................................................ 38

    6. PARTICIPANT MANAGEMENT PROTOCOLS ......................................................... 39 6.1. Schedule of Follow-up Visits ........

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