TY - JOUR
T1 - Long-term weight loss with metformin or lifestyle intervention in the Diabetes prevention Program outcomes study
AU - Diabetes Prevention Program Research Group
AU - Apolzan, John W.
AU - Venditti, Elizabeth M.
AU - Edelstein, Sharon L.
AU - Knowler, William C.
AU - Dabelea, Dana
AU - Boyko, Edward J.
AU - Pi-Sunyer, Xavier
AU - Kalyani, Rita R.
AU - Franks, Paul W.
AU - Srikanthan, Preethi
AU - Gadde, Kishore M.
AU - Bray, George A.
AU - Chatellier, Annie
AU - Arceneaux, Jennifer
AU - Dragg, Amber
AU - Duncan, Crystal
AU - Greenway, Frank L.
AU - Levy, Erma
AU - Lockett, Monica
AU - Ryan, Donna H.
AU - Ehrmann, David
AU - Matulik, Margaret J.
AU - Czech, Kirsten
AU - DeSandre, Catherine
AU - Goldstein, Barry J.
AU - Furlong, Kevin
AU - Smith, Kellie A.
AU - Wildman, Wendi
AU - Pepe, Constance
AU - Goldberg, Ronald B.
AU - Calles, Jeanette
AU - Ojito, Juliet
AU - Castillo-Florez, Sumaya
AU - Florez, Hermes J.
AU - Giannella, Anna
AU - Lara, Olga
AU - Veciana, Beth
AU - Haffner, Steven M.
AU - Hazuda, Helen P.
AU - Montez, Maria G.
AU - Hattaway, Kathy
AU - Lorenzo, Carlos
AU - Martinez, Arlene
AU - Walker, Tatiana
AU - Hamman, Richard F.
AU - Testaverde, Lisa
AU - Crandall, Jill
AU - Shamoon, Harry
AU - Walker, Elizabeth A.
AU - Wylie-Rosett, Judith
N1 - Funding Information:
Primary Funding Source: National Institutes of Health. Grant Support: Research reported in this article was supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health under award number U01 DK048489. During the DPP and the DPPOS, the NIDDK provided funding to the clinical centers and the Coordinating Center for the design and conduct of the study and the 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, the 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 National Cancer Institute; the Office of Research on Women's Health; the National Institute on Minority Health and Health Disparities; 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-Santé) provided medication, and LifeScan donated materials during the DPP and the DPPOS. This research was also supported in part by the intramural research program of the NIDDK. LifeScan, Health o meter, Hoechst Marion Roussel, Merck-Medco Managed Care, Merck and Company, Nike Sports Marketing, SlimFast Foods, and Quaker Oats donated materials, equipment, or medicines for concomitant conditions. McKesson BioServices, Matthews Media Group, and the Henry M. Jackson Foundation provided support services under subcontract with the Coordinating Center.
Funding Information:
Disclosures: Dr. Pi-Sunyer reports personal fees from Novo Nordisk and Zafgen outside the submitted work. Dr. Franks reports grants from Boehringer Ingelheim, Eli Lilly, Janssen, Novo Nordisk, Sanofi Aventis, and Servier and personal fees from Zoe Global outside the submitted work. Dr. Gadde reports grants from AstraZeneca and BioKier and other support from AstraZeneca and the American Diabetes Association outside the submitted work. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOf InterestForms.do?msNum=M18-1605.
Funding Information:
Grant Support: Research reported in this article was supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health under award number U01 DK048489. During the DPP and the DPPOS, the NIDDK provided funding to the clinical centers and the Coordinating Center for the design and conduct of the study and the 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, the 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 National Cancer Institute; the Office of Research on Women's Health; the National Institute on Minority Health and Health Disparities; 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-Santé) provided medication, and LifeScan donated materials during the DPP and the DPPOS. This research was also supported in part by the intramural research program of the NIDDK. LifeScan, Health o meter, Hoechst Marion Roussel, Merck-Medco Managed Care, Merck and Company, Nike Sports Marketing, SlimFast Foods, and Quaker Oats donated materials, equipment, or medicines for concomitant conditions. McKesson BioServices, Matthews Media Group, and the Henry M. Jackson Foundation provided support services under subcontract with the Coordinating Center.
Publisher Copyright:
© 2019 American College of Physicians
PY - 2019
Y1 - 2019
N2 - Background: Identifying reliable predictors of long-term weight loss (LTWL) could lead to improved weight management. Objective: To identify some predictors of LTWL. Design: The DPP (Diabetes Prevention Program) was a randomized controlled trial that compared weight loss with metformin, intensive lifestyle intervention (ILS), or placebo. Its Outcomes Study (DPPOS) observed patients after the masked treatment phase ended. (ClinicalTrials.gov: NCT00004992 and NCT00038727) Setting: 27 DPP and DPPOS clinics. Participants: Of the 3234 randomly assigned participants, 1066 lost at least 5% of baseline weight in the first year and were followed for 15 years. Measurements: Treatment assignment, personal characteristics, and weight. Results: After 1 year, 289 (28.5%) participants in the metformin group, 640 (62.6%) in the ILS group, and 137 (13.4%) in the placebo group had lost at least 5% of their weight. After the masked treatment phase ended, the mean weight loss relative to baseline that was maintained between years 6 and 15 was 6.2% (95% CI, 5.2% to 7.2%) in the metformin group, 3.7% (CI, 3.1% to 4.4%) in the ILS group, and 2.8% (CI, 1.3% to 4.4%) in the placebo group. Independent predictors of LTWL included greater weight loss in the first year in all groups, older age and continued metformin use in the metformin group, older age and absence of either diabetes or a family history of diabetes in the ILS group, and higher fasting plasma glucose levels at baseline in the placebo group. Limitation: Post hoc analysis; examination of nonrandomized subsets of randomized groups after year 1. Conclusion: Among persons with weight loss of at least 5% after 1 year, those originally randomly assigned to metformin had the greatest loss during years 6 to 15. Older age and the amount of weight initially lost were the most consistent predictors of LTWL maintenance.
AB - Background: Identifying reliable predictors of long-term weight loss (LTWL) could lead to improved weight management. Objective: To identify some predictors of LTWL. Design: The DPP (Diabetes Prevention Program) was a randomized controlled trial that compared weight loss with metformin, intensive lifestyle intervention (ILS), or placebo. Its Outcomes Study (DPPOS) observed patients after the masked treatment phase ended. (ClinicalTrials.gov: NCT00004992 and NCT00038727) Setting: 27 DPP and DPPOS clinics. Participants: Of the 3234 randomly assigned participants, 1066 lost at least 5% of baseline weight in the first year and were followed for 15 years. Measurements: Treatment assignment, personal characteristics, and weight. Results: After 1 year, 289 (28.5%) participants in the metformin group, 640 (62.6%) in the ILS group, and 137 (13.4%) in the placebo group had lost at least 5% of their weight. After the masked treatment phase ended, the mean weight loss relative to baseline that was maintained between years 6 and 15 was 6.2% (95% CI, 5.2% to 7.2%) in the metformin group, 3.7% (CI, 3.1% to 4.4%) in the ILS group, and 2.8% (CI, 1.3% to 4.4%) in the placebo group. Independent predictors of LTWL included greater weight loss in the first year in all groups, older age and continued metformin use in the metformin group, older age and absence of either diabetes or a family history of diabetes in the ILS group, and higher fasting plasma glucose levels at baseline in the placebo group. Limitation: Post hoc analysis; examination of nonrandomized subsets of randomized groups after year 1. Conclusion: Among persons with weight loss of at least 5% after 1 year, those originally randomly assigned to metformin had the greatest loss during years 6 to 15. Older age and the amount of weight initially lost were the most consistent predictors of LTWL maintenance.
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U2 - 10.7326/M18-1605
DO - 10.7326/M18-1605
M3 - Article
C2 - 31009939
AN - SCOPUS:85066318815
SN - 0003-4819
VL - 170
SP - 682
EP - 690
JO - Annals of Internal Medicine
JF - Annals of Internal Medicine
IS - 10
ER -
