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Impact of diagnosis of diabetes on health-related quality of life among high risk individuals: the Diabetes Prevention Program outcomes study

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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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Authors and Affiliations

Authors

Consortia

Corresponding author

Correspondence to D. Marrero.

Additional information

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.

Fig. 3
figure 3

Two hypothetical scenarios a DPP participant could experience and the corresponding time axis for each scenario. First scenario: the participant remained diabetes-free throughout the follow-up and stayed on the time since DPP randomization axis. Second scenario: the participant was diagnosed of diabetes two years after DPP randomization and jumped to the second time axis of time since diabetes diagnosis

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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