Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes.
Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes.
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DOI：
10.1056/nejmoa1212914
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发表时间：
2013-07-11
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影响因子：
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通讯作者：
Yanovski SZ
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作者：
Look AHEAD Research Group;Wing RR;Bolin P;Brancati FL;Bray GA;Clark JM;Coday M;Crow RS;Curtis JM;Egan CM;Espeland MA;Evans M;Foreyt JP;Ghazarian S;Gregg EW;Harrison B;Hazuda HP;Hill JO;Horton ES;Hubbard VS;Jakicic JM;Jeffery RW;Johnson KC;Kahn SE;Kitabchi AE;Knowler WC;Lewis CE;Maschak-Carey BJ;Montez MG;Murillo A;Nathan DM;Patricio J;Peters A;Pi-Sunyer X;Pownall H;Reboussin D;Regensteiner JG;Rickman AD;Ryan DH;Safford M;Wadden TA;Wagenknecht LE;West DS;Williamson DF;Yanovski SZ
根据短期研究，建议超重和肥胖的2型糖尿病患者减肥，但对心血管疾病的长期影响仍然未知。我们研究了在超重或肥胖的2型糖尿病成年患者中，通过强化生活方式干预减肥是否能降低心血管疾病的发病率和死亡率。我们随机分配了5，145名超重或肥胖的2型糖尿病患者，这些患者来自16个美国中心，接受强化生活方式干预（干预组），通过减少卡路里摄入和增加体力活动或糖尿病支持和教育（对照组）来促进体重减轻。主要结局是在计划的最长13.5年随访期内，随机化后首次发生复合心血管结局（心血管死亡、非致死性心肌梗死、非致死性卒中或住院心绞痛）。当中位随访时间为9.6年时，基于无效分析，试验提前停止。干预组的体重减轻幅度始终大于对照组（1年时为8.6% vs. 0.7%;研究结束时为6.0% vs. 3.5%）。强化的生活方式干预也使血红蛋白A1 c降低更大，健身和所有心血管危险因素（LDL胆固醇除外）的初始改善更大。主要结局发生在干预组403例患者和对照组418例患者中（分别为1.83/100人-年和1.92/100人-年;风险比0.95; 95% CI 0.83 - 1.09，p=0.505）。在我们的研究中，集中于减肥的强化生活方式干预并没有减少超重或肥胖的2型糖尿病成年人的心血管事件。（由卫生与公众服务部和其他部门资助; ClinicalTrials.gov编号，NCT 00017953。
Weight loss is recommended for overweight and obese individuals with type 2 diabetes based on short-term studies, but long-term effects on cardiovascular disease remain unknown. We examined whether intensive lifestyle intervention for weight loss decreased cardiovascular morbidity and mortality in overweight or obese adults with type 2 diabetes. We randomly assigned 5,145 overweight or obese individuals with type 2 diabetes recruited at 16 US centers to intensive lifestyle intervention (the intervention group), which promoted weight loss through decreased calorie intake and increased physical activity, or diabetes support and education (the control group). The primary outcome was the first post-randomization occurrence of a composite cardiovascular outcome (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalized angina) over a planned maximum follow-up of 13.5 years. The trial was stopped early based on a futility analysis when median follow-up was 9.6 years. Weight loss was greater in the intervention group than the control group throughout (8.6% vs. 0.7% at 1 year; 6.0% vs. 3.5% at study end). Intensive lifestyle intervention also produced greater reductions in hemoglobin A1c and greater initial improvements in fitness and all cardiovascular risk factors, except LDL cholesterol. The primary outcome occurred in 403 patients in the intervention group and in 418 in the control group (1.83/100 person-years and 1.92/100 person-years, respectively; hazard ratio 0.95; 95% CI 0.83 to 1.09, p=0.505). In our study, intensive lifestyle intervention focused on weight loss did not reduce cardiovascular events in overweight or obese adults with type 2 diabetes. (Funded by the Department of Health and Human Services and others; ClinicalTrials.gov number, NCT00017953.)