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N Engl J Med. 2013 Jul 11;369(2):145-54. doi: 10.1056/NEJMoa1212914. Epub 2013 Jun 24.

Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes.

Collaborators (542)

Brancati FL, Clark JM, Swartz L, Charleston J, Cheskin L, Stewart K, Rubin R, Arceci J, Danus S, Bolen D, Diggins D, Evans S, Johnson M, Lambert J, Longenecker S, Michalski K, Jiggetts D, Sapun C, Sowers M, Tyler K, Bray GA, Strate A, Greenway FL, Ryan DH, Williamson D, Church T, Champagne C, Myers V, Arceneaux J, Rau K, Begnaud M, Cerniauskas B, Duncan C, Guay H, Johnson C, Jones L, Landry K, Lingle M, Perault J, Puckett C, Smith M, Cox L, Lockett M, Lewis CE, Thomas S, Safford M, Glasser S, DiLillo V, Bragg C, Dobelstein A, Hannum S, Hubbell A, King J, Lee D, Morgan A, Oden L, Wallace J, Roche C, Roche J, Turman J, Nathan DM, Cagliero E, Hayward K, Turgeon H, Goldman V, Delahanty L, Anderson E, Bissett L, Harlan V, Michel T, Larkin M, Stevens C, Horton ES, Jackson SD, Hamdy O, Caballero A, Bain S, Bovaird E, Fargnoli B, Spellman J, Galuski K, Goebel-Fabbri A, Lambert L, Ledbury S, Malloy M, Ovalle K, Blackburn G, Mantzoros C, McNamara A, Spellman K, Hill JO, Miller M, Wyatt H, Van Dorsten B, Regensteiner J, Bochert D, Coelho L, Cohrs P, Green S, Hamilton A, Hamilton J, Leshchinskiy E, Rome L, Thompson T, Craul K, Wang C, Foreyt JP, Reeves RS, Gee M, Pownall H, Balasubramanyam A, Chen CH, Jones P, Burrington M, Gardner AC, Griggs S, Hamilton M, Holley V, Lee S, Liscum SL, Cantu-Lumbreras S, Palencia J, Schmidt J, Thomas J, White C, Johnson KC, Gresham C, Coday M, Jones L, Lichtermann L, Taylor J, Griffin B, Valenski D, Kitabchi AE, Nyenwe E, Lambeth H, Mosby M, Brewer A, Clark D, Crisler A, Cunningham G, Force D, Green D, Kores R, Rosenthal R, Smith E, Jeffery RW, Skarphol T, Thorson C, Bantle JP, Redmon J, Crow RS, Brelje K, Campbell C, Hoelscher L, Jaeb M, James L, Laqua P, Maddy VA, Ockenden T, Rice BI, Tucker AD, Voeller MS, Walcheck C, Pi-Sunyer X, Patricio J, Pal C, Allen L, Crane J, Chong L, Hirsch D, Holowaty MA, Horowitz M, Wadden TA, Maschak-Carey BJ, Berkowitz RI, Braunstein S, Foster G, Glick H, Kumanyika S, Schwartz SS, Bell Y, Carvajal R, Chomentowski H, Davenport R, Fabricatore A, Faulconbridge L, Hesson L, Iqbal N, Kuehnel R, Lipschutz P, Mullen M, Jakicic JM, Kelley DE, Wesche-Thobaben J, Kuller LH, Kriska A, Rickman AD, Ewing L, Korytkowski M, Edmundowicz D, Salata R, Danchenko R, DeBruce T, Elnyczky B, Garcia DO, Harper PH, Harrier S, Heidingsfelder D, Ives D, Mancino J, Martich L, Murray TY, Quirin K, Ritchea JR, Copelli S, Wing RR, Bright R, Pera V, Jakicic J, Tate D, Gorin A, Gallagher K, Bach A, Bancroft B, Bertorelli A, Carey R, Charron T, Chenot H, Chula-Maguire K, Coward P, Cronkite L, Currin J, Daly M, Egan C, Ferguson E, Foss L, Gauvin J, Kieffer D, Lessard L, Maier D, Massaro JP, Monk T, Nicholson R, Patterson E, Phelan S, Raynor H, Raynor D, Robinson N, Robles D, Tavares J, Haffner SM, Hazuda HP, Montez MG, Lorenzo C, Coleman CF, Granado D, Hathaway K, Isaac JC, Ramirez N, Kahn SE, Murillo A, Knopp R, Lipkin E, Trence D, Tsai E, Fattaleh B, Greenberg D, Montgomery B, Morgan-Taggart I, Richmond BA, Socha J, Thomas A, Wesley A, Wheeler D, Knowler WC, Bolin P, Killean T, Manus C, Krakoff J, Curtis JM, Michaels S, Bloomquist P, Bennett PH, Fallis B, Hollowbreast DF, Johnson R, Meacham M, Morris C, Nelson J, Percy C, Poorthunder P, Sangster S, Shovestull LA, Smart M, Smiley J, Thomas T, Toledo K, Peters A, Ghazarian S, Beale E, Konersman K, Quintero-Varela B, Ramirez E, Rios G, Rodriguez G, Ruelas V, Serafin-Dokhan S, Walker M, Espeland MA, Bahnson JL, Wagenknecht LE, Reboussin D, Rejeski W, Bertoni AG, Lang W, Lawlor MS, Lefkowitz D, Miller GD, Reynolds PS, Ribisl PM, Vitolins M, Beavers D, Chen H, Kitzman D, West DS, Friedman LM, Prineas R, Samdarshi T, Dotson KM, Hodges A, Limprevil-Divers D, Wall K, Williams CC, Anderson A, Barnes JM, Barr M, Beckner TD, Davis C, Del Valle-Fagan T, Earl T, Franks M, Goode C, Griffin J, Harvin L, Hontz MA, Gaussoin SA, Hire DG, Hogan P, King M, Lane K, Neiberg RH, Rushing JT, Sammah VE, Walkup MP, Windham T, Nevitt M, Schwartz A, Shepherd J, Rahorst M, Palermo L, Ewing S, Hayashi C, Maeda J, Marcovina SM, Hurting J, Albers JJ, Gaur V, Soliman EZ, Campbell C, Zhang ZM, Barr M, Hensley S, Hu J, Keasler L, Li Y, Mayer-Davis EJ, Moran R, Foushee R, Hall NJ, Evans M, Harrison B, Hubbard VS, Yanovski SZ, Cooper LS, Kaufman P, Stylianou M, Gregg EW, Zhang P, Cheskin L, Crow RS, Friedman LM, Gaussoin SA, Glasser S, Hogan P, Johnson KC, Lefkowitz D, Lewis CE, Prineas R, Redmon J, Reynolds PS, Safford M, Samdarshi T, Williams CC, Cooper LS, Dotson KM, Evans M, Foster G, Hill JO, Jakicic JM, McCaffery J, Reboussin D, Bray GA, Crow RS, Evans M, Gregg EW, Hill JO, Hodges A, Jeffery RW, Killean T, Montez MG, Reboussin D, Swartz L, Thomas S, Bahnson JL, Brancati FL, Dotson KM, Espeland MA, Evans M, Lewis CE, Maschak-Carey BJ, Nathan DM, Rubin R, West DS, Wing RR, Bahnson JL, Egan C, Evans M, Goldman V, Hodges A, Limprevil-Divers D, Mancino J, Manus C, Peters A, Skarphol T, Taylor J, Wesche-Thobaben J, Bertoni AG, Dotson KM, Espeland MA, Evans M, Glick H, Hire DG, Killean T, Knowler WC, Lawlor MS, Limprevil-Divers D, Montez MG, Rushing JT, Tsai AG, Zhang P, Bahnson JL, Espeland MA, Evans M, Pi-Sunyer X, Wagenknecht LE, Wing RR, Clark JM, Espeland MA, Gregg EW, Hodges A, Hubbard VS, Johnson KC, Kahn SE, Kitabchi AE, Knowler WC, Limprevil-Divers D, Nathan DM, Ryan DH, Pi-Sunyer X, Safford M, Wagenknecht LE, Williams CC, Wing RR, Yanovski SZ, Arceneaux J, Charleston J, Dotson KM, Egan C, Evans M, Foushee R, Gee M, Gresham C, Hall NJ, Johnson R, Knopp R, Lambeth H, Lichtermann L, Patricio J, Reeves R, Rubin R, Strate A, Van Dorsten B, Bahnson JL, Bertoni AG, Brancati FL, Cooper LS, Curtis JM, Gaussoin SA, Ghazarian S, Hubbard VS, Kahn SE, Maschak-Carey BJ, Murillo A, Peters A, Pi-Sunyer X, Yanovski SZ, Bantle JP, Berkowitz RI, Bolin P, Cerniauskas B, Delahanty L, Dotson KM, Evans M, Foreyt JP, Gregg EW, Hazuda HP, Jakicic JM, Kaufmann PG, Kuczmarski R, Kumanyika S, Miller GD, Miller M, Pal C, Rejeski W, Rickman AD, Vitolins M, Wadden TA, West DS, Williamson D, Wing RR, Yanovski SZ.

Erratum in

  • N Engl J Med. 2014 May 8;370(19):1866.

Abstract

BACKGROUND:

Weight loss is recommended for overweight or obese patients with type 2 diabetes on the basis of short-term studies, but long-term effects on cardiovascular disease remain unknown. We examined whether an intensive lifestyle intervention for weight loss would decrease cardiovascular morbidity and mortality among such patients.

METHODS:

In 16 study centers in the United States, we randomly assigned 5145 overweight or obese patients with type 2 diabetes to participate in an intensive lifestyle intervention that promoted weight loss through decreased caloric intake and increased physical activity (intervention group) or to receive diabetes support and education (control group). The primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for angina during a maximum follow-up of 13.5 years.

RESULTS:

The trial was stopped early on the basis of a futility analysis when the median follow-up was 9.6 years. Weight loss was greater in the intervention group than in the control group throughout the study (8.6% vs. 0.7% at 1 year; 6.0% vs. 3.5% at study end). The intensive lifestyle intervention also produced greater reductions in glycated hemoglobin and greater initial improvements in fitness and all cardiovascular risk factors, except for low-density-lipoprotein cholesterol levels. The primary outcome occurred in 403 patients in the intervention group and in 418 in the control group (1.83 and 1.92 events per 100 person-years, respectively; hazard ratio in the intervention group, 0.95; 95% confidence interval, 0.83 to 1.09; P=0.51).

CONCLUSIONS:

An intensive lifestyle intervention focusing on weight loss did not reduce the rate of cardiovascular events in overweight or obese adults with type 2 diabetes. (Funded by the National Institutes of Health and others; Look AHEAD ClinicalTrials.gov number, NCT00017953.).

PMID:
23796131
[PubMed - indexed for MEDLINE]
PMCID:
PMC3791615
Free PMC Article

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