10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study.
10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study.
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DOI：
10.1016/s0140-6736(09)61457-4
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发表时间：
2009-11-14
期刊：
影响因子：
168.9
通讯作者：
Sarkin, A. J.
中科院分区：
文献类型：
--
作者：
Bray, G. A.;Chatellier, A.;Duncan, C.;Greenway, F. L.;Levy, E.;Ryan, D. H.;Polonsky, K. S.;Tobian, J.;Ehrmann, D.;Matulik, M. J.;Clark, B.;Czech, K.;DeSandre, C.;Hilbrich, R.;McNabb, W.;Semenske, A. R.;Goldstein, B. J.;Smith, K. A.;Wildman, W.;Pepe, C.;Goldberg, R. B.;Calles, J.;Ojito, J.;Castillo-Florez, S.;Florez, H. J.;Giannella, A.;Lara, O.;Veciana, B.;Haffner, S. M.;Montez, M. G.;Lorenzo, C.;Martinez, A.;Hamman, R. F.;Testaverde, L.;Bouffard, A.;Dabelea, D.;Jenkins, T.;Lenz, D.;Perreault, L.;Price, D. W.;Steinke, S. C.;Horton, E. S.;Poirier, C. S.;Swift, K.;Caballero, E.;Jackson, S. D.;Lambert, L.;Lawton, K. E.;Ledbury, S.;Kahn, S. E.;Montgomery, B. K.;Fujimoto, W.;Knopp, R. H.;Lipkin, E. W.;Marr, M.;Murillo, A.;Trence, D.;Kitabchi, A. E.;Murphy, M. E.;Applegate, W. B.;Bryer-Ash, M.;Dagogo-Jack, S.;Frieson, S. L.;Lambeth, H.;Lichtermann, L. C.;Otkaei, H.;Rutledge, L. M. K.;Sherman, A. R.;Smith, C. M.;Soberman, J. E.;Williams-Cleaves, B.;Metzger, B. E.;Molitch, M. E.;Johnson, M. K.;Giles, M. M.;Larsen, D.;Niznik, C.;Pen, S. C.;Schinleber, P. A.;Nathan, D. M.;McKitrick, C.;Turgeon, H.;Abbott, K.;Altshuler, D.;Anderson, E.;Bissett, L.;Cagliero, E.;D'Anna, K.;Delahanty, L.;Florez, J. C.;Goldman, V.;Poulos, A.;Tseng, B.;Barrett-Connor, E.;Carrion-Petersen, M. L.;Horne, J.;Leos, D.;Mudaliar, S.;Smith, J.;Vejvoda, K.;Pi-Sunyer, F. X.;Lee, J. E.;Foo, S. T.;Hagamen, S.;Marrero, D. G.;Kelly, S. M.;Ackermann, R. T.;Fineberg, E. S.;Hadden, A.;Jackson, M. A.;Kirkman, M. S.;Mather, K. J.;Roach, P. J.;Wheeler, M. L.;Ratner, R. E.;Aroda, V.;Shapiro, S.;Bavido-Arrage, C.;Gibbs, P.;Uwaifo, Gl;Wiggins, R.;Saad, M. F.;Watson, K.;Botrous, M.;Jinagouda, S.;Budget, M.;Conzues, C.;Magpuri, P.;Ngo, K.;Xapthalamous, K.;White, N. H.;Das, S.;Santiago, A.;Brown, A. L.;Wernimont, C.;Saudek, C. D.;Whittington, T.;Clark, J. M.;Greene, A.;Jiggetts, D.;Mosley, H.;Reusing, J.;Rubin, R. R.;Stephen, S.;Utsey, E.;Schade, D. S.;Adams, K. S.;Hemphill, C.;Hyde, P.;Butler, L.;Canady, J. L.;Colleran, K.;Gonzales, Y.;Hernandez-McGinnis, D. A.;Katz, P.;King, C.;Crandall, J.;Brown-Friday, J. O.;Adorno, E.;Duffy, H.;Martinez, H.;Pompi, D.;Shamoon, H.;Walker, E. A.;Wylie-Rosett, J.;Orchard, T.;Jeffries, S.;Kramer, M. K.;Smith, M.;Kriska, A.;Pettigrew, J.;Semler, L.;Venditti, E.;Weinzierl, V.;Arakaki, R. F.;Baker-Ladao, N. K.;Isonaga, M. K.;Bermudez, N. E.;Mau, M. K.;Knowler, W. C.;Cooeyate, N.;Hoskin, M. A.;Natewa, C.;Percy, C. A.;Acton, K. J.;Andre, V. L.;Begay, S.;Bucca, B. C.;Cook, S.;Doughty, M. S.;Glass, J.;Glass, M.;Hanson, R. L.;Hassenpflug, D.;Ingraham, L. E.;Kobus, K. M.;Krakoff, J.;Manus, C.;McCabe, C.;Michaels, S.;Morgan, T.;Nelson, J. A.;Roy, R. J.;Smart, M.;Tonemah, D. P.;Wilson, C.;Fowler, S.;Brenneman, T.;Abebe, S.;Bamdad, J.;Callaghan, J.;Christophi, C. A.;Edelstein, S. L.;Gao, Y.;Gooding, R.;Gottlieb, A.;Grover, N.;Hoffman, H.;Jablonski, K.;Katz, R.;Kolinjivadi, P.;Lachin, J. M.;Ma, Y.;Reamer, S.;Sapozhnikova, A.;Sherif, H.;Temprosa, M.;Venditti, E. M.;Kriska, A. M.;Semler, L.;Weinzierl, V.;Marcovina, S.;Strylewicz, G.;Albers, J.;Prineas, R. J.;Alexander, T.;Campbell, C.;Hall, S.;Hensley, S.;Li, Y.;Mills, M.;Soliman, E.;Zhang, Z.;Fradkin, J.;Garfield, S.;Mayer-Davis, E.;Moran, R. R.;Ganiats, T.;Sarkin, A. J.
在为期2.8年的糖尿病预防计划（DPP）随机临床试验中，与安慰剂相比，强化生活方式干预使高危成人糖尿病发病率降低了58%，二甲双胍降低了31%。我们研究了这些影响的长期持续性。所有活跃的DPP参与者都有资格继续随访。2766/3150例（88%）入组，接受中位额外随访5.7年（IQR 5.5 - 5.8）。910名参与者来自生活方式，924名来自二甲双胍，932名来自原始安慰剂组。在DPP中强化生活方式干预的益处的基础上，所有三组都提供了分组实施的生活方式干预。二甲双胍组继续接受二甲双胍治疗（850 mg，每日两次，可耐受），参与者对分配不设盲，原始生活方式干预组提供额外的生活方式支持。主要结局是根据美国糖尿病协会标准的糖尿病发展。该研究在ClinicalTrials.gov注册，编号NCT 00038727。在随机分配至DPP后的10年（IQR 9.0 - 10.5）随访期间，原始生活方式组体重减轻，然后部分恢复。二甲双胍的适度体重减轻得以维持。DPP期间，强化生活方式干预组的糖尿病发病率为4.8例/100人-年（95%CI 4.1 - 5.7），二甲双胍组为7.8例/100人-年（6.8 - 8.8），安慰剂组为11.0例/100人-年（95%CI 9.8 - 12.3）。在这项随访研究中，治疗组之间的糖尿病发病率相似：生活方式组为5.9/100人-年（5.1 - 6.8），二甲双胍组为4.9（4.2 - 5.7），安慰剂组为5.6（4.8 - 6.5）。与安慰剂组相比，生活方式组自DPP随机化后10年内的糖尿病发病率降低了34%（24-42），二甲双胍组降低了18%（7-28）。在DPP治疗后的随访中，前安慰剂组和二甲双胍组的发病率下降到与前生活方式组相同，但生活方式组的糖尿病累积发病率仍然最低。通过生活方式干预或二甲双胍预防或延缓糖尿病可持续至少10年。国家糖尿病、消化和肾脏疾病研究所（NIDDK）。
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. 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. 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. 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. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).