Abstract
Purpose
The purpose of this study is to assess if diagnosis of type 2 diabetes affected health-related quality of life (HRQoL) among participants in the Diabetes Prevention Program/Diabetes Prevention Program Outcome Study and changes with treatment or diabetes duration.
Methods
3,210 participants with pre-diabetes were randomized to metformin (MET), intensive lifestyle intervention (ILS), or placebo (PLB). HRQoL was assessed using the SF-36 including: (1) 8 SF-36 subscales; (2) the physical component (PCS) and mental component summary (MCS) scores; and (3) the SF-6D. The sample was categorized by diabetes free versus diagnosed. For diagnosed subgroup, mean scores in the diabetes-free period, at 6 months, 2, 4 and 6 years post-diagnosis, were compared.
Results
PCS and SF-6D scores declined in all participants in all treatment arms (P < .001). MCS scores did not change significantly in any treatment arm regardless of diagnosis. ILS participants reported a greater decrease in PCS scores at 6 months post-diagnosis (P < .001) and a more rapid decline immediately post-diagnosis in SF-6D scores (P = .003) than the MET or PLB arms. ILS participants reported a significant decrease in the social functioning subscale at 6 months (P < .001) and two years (P < .001) post-diagnosis.
Conclusions
Participants reported a decline in measures of overall health state (SF-6D) and overall physical HRQoL, whether or not they were diagnosed with diabetes during the study. There was no change in overall mental HRQoL. Participants in the ILS arm with diabetes reported a more significant decline in some HRQoL measures than those in the MET and PLB arms that developed diabetes.
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Acknowledgements:
The Research Group gratefully acknowledges the commitment and dedication of the participants of the DPP and DPPOS. During the DPPOS, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health provided funding to the clinical centers and the Coordinating Center for the design and conduct of the study, and collection, management, analysis, and interpretation of the data (U01 DK048489). The Southwestern American Indian Centers were supported directly by the NIDDK, including its Intramural Research Program, and the Indian Health Service. The General Clinical Research Center Program, National Center for Research Resources, and the Department of Veterans Affairs supported data collection at many of the clinical centers. Funding was also provided by the National Institute of Child Health and Human Development, the National Institute on Aging, the National Eye Institute, the National Heart Lung and Blood Institute, the Office of Research on Women’s Health, the National Center for Minority Health and Human Disease, the Centers for Disease Control and Prevention, and the American Diabetes Association. Bristol-Myers Squibb and Parke-Davis provided additional funding and material support during the DPP, Lipha (Merck-Sante) provided medication, and LifeScan Inc. donated materials during the DPP and DPPOS. We thank the thousands of volunteers in this program for their devotion to the goal of diabetes prevention. LifeScan Inc., Health O Meter, Hoechst Marion Roussel, Inc., Merck-Medco Managed Care, Inc., Merck and Co., Nike Sports Marketing, Slim Fast Foods Co., and Quaker Oats Co. donated materials, equipment, or medicines for concomitant conditions. McKesson BioServices Corp., Matthews Media Group, Inc., and the Henry M. Jackson Foundation provided support services under subcontract with the Coordinating Center. The opinions expressed are those of the investigators and do not necessarily reflect the views of the funding agencies.
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Clinical trials Registry DPPOS: NCT00038727 and DPP: NCT00004992.
A complete list of the DPPOS Research Group investigators is shown in the Appendix 2.
Appendices
Appendix 1
See Fig. 3.
Appendix 2: DPPOS research group investigators
Pennington Biomedical Research Center (Baton Rouge, LA)
George A. Bray, MD*
Annie Chatellier, RN, CCRC**
Crystal Duncan, LPN
Frank L. Greenway, MD
Erma Levy, RD
Donna H. Ryan, MD
University of Chicago (Chicago, IL)
Kenneth S. Polonsky, MD*
Janet Tobian, MD, PhD*
David Ehrmann, MD*
Margaret J. Matulik, RN, BSN**
Bart Clark, MD
Kirsten Czech, MS
Catherine DeSandre, BA
Ruthanne Hilbrich, RD
Wylie McNabb, EdD
Ann R. Semenske, MS, RD
Jefferson Medical College (Philadelphia, PA)
Barry J. Goldstein, MD, PhD*
Kevin Furlong, DO*
Kellie A. Smith, RN, MSN**
Wendi Wildman, RN**
Constance Pepe, MS, RD
University of Miami (Miami, FL)
Ronald B. Goldberg, MD*
Jeanette Calles, MSEd**
Juliet Ojito, RN**
Sumaya Castillo-Florez, MPH
Hermes J. Florez, MD, PhD
Anna Giannella, RD, MS
Olga Lara
Beth Veciana
The University of Texas Health Science Center (San Antonio, TX)
Steven M. Haffner, MD, MPH*
Helen P. Hazuda, PhD*
Maria G. Montez, RN, MSHP, CDE**
Carlos Lorenzo, MD, PhD
Arlene Martinez, RN, BSN, CDE
University of Colorado (Denver, CO)
Richard F. Hamman, MD, DrPH*
Lisa Testaverde, MS**
Alexis Bouffard, MA, RN, BSN
Dana Dabelea, MD, PhD
Tonya Jenkins, RD, CDE
Dione Lenz, RN, BSN, CDE
Leigh Perreault, MD
David W. Price, MD
Sheila C. Steinke, MS
Joslin Diabetes Center (Boston, MA)
Edward S. Horton, MD*
Catherine S. Poirier, RN, BSN**
Kati Swift, RN, BSN**
Enrique Caballero, MD
Sharon D. Jackson, MS, RD, CDE
Lori Lambert, MS, RD, LD
Kathleen E. Lawton, RN
Sarah Ledbury, Med, RD
VA Puget Sound Health Care System and University of Washington (Seattle, WA)
Steven E. Kahn, MB, ChB*
Brenda K. Montgomery, RN, BSN, CDE**
Wilfred Fujimoto, MD
Robert H. Knopp, MD
Edward W. Lipkin, MD
Michelle Marr, BA
Anne Murillo, BS
Dace Trence, MD
University of Tennessee (Memphis, TN)
Abbas E. Kitabchi, PhD, MD, FACP*
Mary E. Murphy, RN, MS, CDE, MBA**
William B. Applegate, MD, MPH
Michael Bryer-Ash, MD
Samuel Dagogo-Jack, MD, MSc, FRCP, FACP
Sandra L. Frieson, RN
Helen Lambeth, RN, BSN
Lynne C. Lichtermann, RN, BSN
Hooman Otkaei, MD
Lily M.K. Rutledge, RN, BSN
Amy R. Sherman, RD, LD
Clara M. Smith, RD, MHP, LDN
Judith E. Soberman, MD
Beverly Williams-Cleaves, MD
Northwestern University’s Feinberg School of Medicine (Chicago, IL)
Boyd E. Metzger, MD*
Mark E. Molitch, MD*
Mariana K. Johnson, MS, RN**
Mimi M. Giles, MS, RD
Diane Larsen, BS
Charlotte Niznik, MS, RN, CDE
Samsam C. Pen, BA
Pamela A. Schinleber, RN, MS
Massachusetts General Hospital (Boston, MA)
David M. Nathan, MD*
Charles McKitrick, BSN**
Heather Turgeon, BSN**
Kathy Abbott
Ellen Anderson, MS, RD
Laurie Bissett, MS, RD
Enrico Cagliero, MD
Kali D’Anna
Linda Delahanty, MS, RD
Jose C. Florez, MD, PhD+
Valerie Goldman, MS, RD
Alexandra Poulos
Beverly Tseng
University of California-San Diego (San Diego, CA)
Elizabeth Barrett-Connor, MD*
Mary Lou Carrion-Petersen, RN, BSN**
Javiva Horne, RD
Diana Leos, RN, BSN
Sundar Mudaliar, MD
Jean Smith, RN
Karen Vejvoda, RN, BSN, CDE, CCRC
St. Luke’s-Roosevelt Hospital (New York, NY)
F. Xavier Pi-Sunyer, MD*
Jane E. Lee, MS**
Sandra T. Foo, MD
Susan Hagamen, MS, RN, CDE
Indiana University (Indianapolis, IN)
David G. Marrero, PhD*
Susie M. Kelly, RN, CDE**
Ronald T. Ackermann, MD
Edwin S. Fineberg, MD
Angela Hadden
Marcia A. Jackson
Marion S. Kirkman, MD
Kieren J. Mather, MD
Paris J. Roach, MD
Madelyn L. Wheeler, RD
Medstar Research Institute (Washington, DC)
Robert E. Ratner, MD*
Vanita Aroda, MD*
Sue Shapiro, RN, BSN, CCRC**
Catherine Bavido-Arrage, MS, RD, LD
Peggy Gibbs
Gabriel Uwaifo, MD
Renee Wiggins, RD
University of Southern California/UCLA Research Center (Alhambra, CA)
Mohammed F. Saad, MD*
Karol Watson, MD*
Medhat Botrous, MD**
Sujata Jinagouda, MD**
Maria Budget
Claudia Conzues
Perpetua Magpuri
Kathy Ngo
Kathy Xapthalamous
Washington University (St. Louis, MO)
Neil H. White, MD, CDE*
Samia Das, MS, MBA, RD, LD**
Ana Santiago, RD
Angela L. Brown, MD
Cormarie Wernimont, RD, LD
Johns Hopkins School of Medicine (Baltimore, MD)
Christopher D. Saudek, MD* (deceased)
Sherita Hill Golden, MD, MHS, FAHA*
Tracy Whittington, BS**
Jeanne M. Clark, MD
Alicia Greene
Dawn Jiggetts
Henry Mosley
John Reusing
Richard R. Rubin, PhD
Shawne Stephens
Evonne Utsey
University of New Mexico (Albuquerque, NM)
David S. Schade, MD*
Karwyn S. Adams, RN, MSN**
Claire Hemphill, RN, BSN**
Penny Hyde, RN, BSN**
Lisa Butler, BUS
Janene L. Canady, RN, CDE
Kathleen Colleran, MD
Ysela Gonzales, RN, MSN
Doris A. Hernandez-McGinnis
Patricia Katz, LPN
Carolyn King
Albert Einstein College of Medicine (Bronx, NY)
Jill Crandall, MD*
Janet O. Brown, RN, MPH, MSN**
Elsie Adorno, BS
Helena Duffy, MS, C-ANP
Helen Martinez, RN, MSN, FNP-C
Dorothy Pompi, BA
Harry Shamoon, MD
Elizabeth A. Walker, RN, DNSc, CDE
Judith Wylie-Rosett, EdD, RD
University of Pittsburgh (Pittsburgh, PA)
Trevor Orchard, MD*
Susan Jeffries, RN, MSN**
M. Kaye Kramer, BSN, MPH**
Marie Smith, RN, BSN**
Rena R. Wing, PhD
Andrea Kriska, PhD
Jessica Pettigrew, CMA
Linda Semler, MS, RD
Elizabeth Venditti, PhD
Valarie Weinzierl, BS
University of Hawaii (Honolulu, HI)
Richard F. Arakaki, MD*
Narleen K. Baker-Ladao, BS**
Mae K. Isonaga, RD, MPH**
Nina E. Bermudez, MS
Marjorie K. Mau, MD
Southwest American Indian Centers (Phoenix, AZ; Shiprock, NM; Zuni, NM)
William C. Knowler, MD, DrPH*+
Norman Cooeyate**
Mary A. Hoskin, RD, MS**
Camille Natewa**
Carol A. Percy, RN, MS**
Kelly J. Acton, MD, MPH
Vickie L. Andre, RN, FNP
Shandiin Begay, MPH
Brian C. Bucca, OD, FAAO
Sherron Cook
Matthew S. Doughty, MD
Justin Glass, MD
Martia Glass, MD
Robert L. Hanson, MD, MPH
Doug Hassenpflug, OD
Louise E. Ingraham, MS, RD, LN
Kathleen M. Kobus, RNC-ANP
Jonathan Krakoff, MD
Catherine Manus, LPN
Cherie McCabe
Sara Michaels, MD
Tina Morgan
Julie A. Nelson, RD
Robert J. Roy
Miranda Smart
Darryl P. Tonemah, PhD
Charlton Wilson, MD
George Washington University Biostatistics Center (DPP Coordinating Center Rockville, MD)
Sarah Fowler, PhD*
Tina Brenneman**
Solome Abebe, MS
Julie Bamdad, MS
Melanie Barkalow
Joel Bethepu
Tsedenia Bezabeh
Jackie Callaghan
Costas Christophi, PhD
Sharon L. Edelstein, ScM
Yuping Gao
Robert Gooding
Adrienne Gottlieb
Nisha Grover
Heather Hoffman, PhD
Kathleen Jablonski, PhD
Richard Katz, MD
Preethy Kolinjivadi, MS
John M. Lachin, ScD
Yong Ma, PhD
Susan Reamer
Alla Sapozhnikova
Hanna Sherif, MS
Marinella Temprosa, MS
Qing Pan, PhD
Mary Foulkes, PhD
Nicole Butler
Lifestyle Resource Core
Elizabeth M. Venditti, PhD*
Andrea M. Kriska, PhD
Linda Semler, MS, RD
Valerie Weinzierl, BS
Central Biochemistry Laboratory (Seattle, WA)
Santica Marcovina, PhD, ScD*
Greg Strylewicz, PhD**
John Albers, PhD
Epidemiological Cardiology Research Center-Epicare (Winston-Salem, NC)
Ronald J. Prineas, MD, PhD*
Teresa Alexander
Charles Campbell, MS
Sharon Hall
Susan Hensley
Yabing Li, MD
Margaret Mills
Elsayed Soliman, MD
Zhuming Zhang, MD
Fundus Photo Reading Center (Madison, WI)
Ronald Danis, MD*
Matthew Davis, MD*
Larry Hubbard*
Ryan Endres**
Deborah Elsas**
Samantha Johnson**
Vonnie Gama
Anne Goulding
Carotid Ultrasound
Gregory Evans
CT Scan Reading Center
Elizabeth Stamm
Neurocognitive Assessment Group
Jose A. Luchsinger, MD, MPH
NIH/NIDDK (Bethesda, MD)
Judith Fradkin, MD
Sanford Garfield, PhD
Centers for Disease Control & Prevention (Atlanta, GA)
Edward Gregg, PhD
Ping Zhang, PhD
University of Michigan (Ann Arbor, MI)
William H. Herman, MD, MPH
Morton B. Brown, PhD
Nutrition Coding Center (Columbia, SC)
Elizabeth Mayer-Davis, PhD*
Robert R. Moran, PhD**
Quality of Well-Being Center (La Jolla, CA)
Ted Ganiats, MD*
Andrew J. Sarkin, PhD**
Naomi Katzir
Erik Groessl, PhD
Coronary Artery Calcification Reading Center
Matthew Budoff, MD
Chris Dailing
Denotes Principal Investigator*
Denotes Program Coordinator**
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Marrero, D., Pan, Q., Barrett-Connor, E. et al. Impact of diagnosis of diabetes on health-related quality of life among high risk individuals: the Diabetes Prevention Program outcomes study. Qual Life Res 23, 75–88 (2014). https://doi.org/10.1007/s11136-013-0436-3
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DOI: https://doi.org/10.1007/s11136-013-0436-3