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Lancet. 2009 Nov 14;374(9702):1677-86. doi: 10.1016/S0140-6736(09)61457-4. Epub 2009 Oct 29.

10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study.

Collaborators (249)

Bray GA, Chatellier A, Duncan C, Greenway FL, Levy E, Ryan DH, Polonsky KS, Tobian J, Ehrmann D, Matulik MJ, Clark B, Czech K, DeSandre C, Hilbrich R, McNabb W, Semenske AR, Goldstein BJ, Smith KA, Wildman W, Pepe C, Goldberg RB, Calles J, Ojito J, Castillo-Florez S, Florez HJ, Giannella A, Lara O, Veciana B, Haffner SM, Montez MG, Lorenzo C, Martinez A, Hamman RF, Testaverde L, Bouffard A, Dabelea D, Jenkins T, Lenz D, Perreault L, Price DW, Steinke SC, Horton ES, Poirier CS, Swift K, Caballero E, Jackson SD, Lambert L, Lawton KE, Ledbury S, Kahn SE, Montgomery BK, Fujimoto W, Knopp RH, Lipkin EW, Marr M, Murillo A, Trence D, Kitabchi AE, Murphy ME, Applegate WB, Bryer-Ash M, Dagogo-Jack S, Frieson SL, Lambeth H, Lichtermann LC, Otkaei H, Rutledge LM, Sherman AR, Smith CM, Soberman JE, Williams-Cleaves B, Metzger BE, Molitch ME, Johnson MK, Giles MM, Larsen D, Niznik C, Pen SC, Schinleber PA, Nathan DM, McKitrick C, Turgeon H, Abbott K, Altshuler D, Anderson E, Bissett L, Cagliero E, D'Anna K, Delahanty L, Florez JC, Goldman V, Poulos A, Tseng B, Barrett-Connor E, Carrion-Petersen ML, Horne J, Leos D, Mudaliar S, Smith J, Vejvoda K, Pi-Sunyer FX, Lee JE, Foo ST, Hagamen S, Marrero DG, Kelly SM, Ackermann RT, Fineberg ES, Hadden A, Jackson MA, Kirkman MS, Mather KJ, Roach PJ, Wheeler ML, Ratner RE, Aroda V, Shapiro S, Bavido-Arrage C, Gibbs P, Uwaifo G, Wiggins R, Saad MF, Watson K, Botrous M, Jinagouda S, Budget M, Conzues C, Magpuri P, Ngo K, Xapthalamous K, White NH, Das S, Santiago A, Brown AL, Wernimont C, Saudek CD, Whittington T, Clark JM, Greene A, Jiggetts D, Mosley H, Reusing J, Rubin RR, Stephen S, Utsey E, Schade DS, Adams KS, Hemphill C, Hyde P, Butler L, Canady JL, Colleran K, Gonzales Y, Hernandez-McGinnis DA, Katz P, King C, Crandall J, Brown-Friday JO, Adorno E, Duffy H, Martinez H, Pompi D, Shamoon H, Walker EA, Wylie-Rosett J, Orchard T, Jeffries S, Kramer MK, Smith M, Kriska A, Pettigrew J, Semler L, Venditti E, Weinzierl V, Arakaki RF, Baker-Ladao NK, Isonaga MK, Bermudez NE, Mau MK, Knowler WC, Cooeyate N, Hoskin MA, Natewa C, Percy CA, Acton KJ, Andre VL, Begay S, Bucca BC, Cook S, Doughty MS, Glass J, Glass M, Hanson RL, Hassenpflug D, Ingraham LE, Kobus KM, Krakoff J, Manus C, McCabe C, Michaels S, Morgan T, Nelson JA, Roy RJ, Smart M, Tonemah DP, Wilson C, Fowler S, Brenneman T, Abebe S, Bamdad J, Callaghan J, Christophi CA, Edelstein SL, Gao Y, Gooding R, Gottlieb A, Grover N, Hoffman H, Jablonski K, Katz R, Kolinjivadi P, Lachin JM, Ma Y, Reamer S, Sapozhnikova A, Sherif H, Temprosa M, Venditti EM, Kriska AM, Semler L, Weinzierl V, Marcovina S, Strylewicz G, Albers J, Prineas RJ, Alexander T, Campbell C, Hall S, Hensley S, Li Y, Mills M, Soliman E, Zhang Z, Fradkin J, Garfield S, Mayer-Davis E, Moran RR, Ganiats T, Sarkin AJ.

Erratum in

  • Lancet. 2009 Dec 19;374(9707):2054.

Abstract

BACKGROUND:

In the 2.8 years of the Diabetes Prevention Program (DPP) randomised clinical trial, diabetes incidence in high-risk adults was reduced by 58% with intensive lifestyle intervention and by 31% with metformin, compared with placebo. We investigated the persistence of these effects in the long term.

METHODS:

All active DPP participants were eligible for continued follow-up. 2766 of 3150 (88%) enrolled for a median additional follow-up of 5.7 years (IQR 5.5-5.8). 910 participants were from the lifestyle, 924 from the metformin, and 932 were from the original placebo groups. On the basis of the benefits from the intensive lifestyle intervention in the DPP, all three groups were offered group-implemented lifestyle intervention. Metformin treatment was continued in the original metformin group (850 mg twice daily as tolerated), with participants unmasked to assignment, and the original lifestyle intervention group was offered additional lifestyle support. The primary outcome was development of diabetes according to American Diabetes Association criteria. Analysis was by intention-to-treat. This study is registered with ClinicalTrials.gov, number NCT00038727.

FINDINGS:

During the 10.0-year (IQR 9.0-10.5) follow-up since randomisation to DPP, the original lifestyle group lost, then partly regained weight. The modest weight loss with metformin was maintained. Diabetes incidence rates during the DPP were 4.8 cases per 100 person-years (95% CI 4.1-5.7) in the intensive lifestyle intervention group, 7.8 (6.8-8.8) in the metformin group, and 11.0 (9.8-12.3) in the placebo group. Diabetes incidence rates in this follow-up study were similar between treatment groups: 5.9 per 100 person-years (5.1-6.8) for lifestyle, 4.9 (4.2-5.7) for metformin, and 5.6 (4.8-6.5) for placebo. Diabetes incidence in the 10 years since DPP randomisation was reduced by 34% (24-42) in the lifestyle group and 18% (7-28) in the metformin group compared with placebo.

INTERPRETATION:

During follow-up after DPP, incidences in the former placebo and metformin groups fell to equal those in the former lifestyle group, but the cumulative incidence of diabetes remained lowest in the lifestyle group. Prevention or delay of diabetes with lifestyle intervention or metformin can persist for at least 10 years.

FUNDING:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Comment in

PMID:
19878986
[PubMed - indexed for MEDLINE]
PMCID:
PMC3135022
Free PMC Article

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