Effect of a long-term behavioural weight loss intervention on nephropathy in overweight or obese adults with type 2 diabetes: a secondary analysis of the Look AHEAD randomised clinical trial.

Effect of a long-term behavioural weight loss intervention on nephropathy in overweight or obese adults with type 2 diabetes: a secondary analysis of the Look AHEAD randomised clinical trial.
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DOI:
10.1016/s2213-8587(14)70156-1
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发表时间:
2014-10
影响因子:
44.5
通讯作者:
Yanovski, S. Z.
Yanovski, S. Z.
中科院分区:
医学1区
文献类型:
--
作者:
Knowler, W. C.;Bahnson, J. L.;Bantle, J. P.;Bertoni, A. G.;Bray, G. A.;Chen, H.;Cheskin, L.;Clark, J. M.;Egan, C.;Evans, M.;Foreyt, J. P.;Glasser, S. P.;Greenway, F. L.;Gregg, E. W.;Hazuda, H. P.;Hill, J. O.;Horton, E. S.;Hubbard, V. S.;Jakicic, J. M.;Jeffery, R. W.;Johnson, K. C.;Kahn, S. E.;Kitabchi, A. E.;Korytkowski, M.;Krakoff, J.;Kure, A.;Lewis, C. E.;Maschak-Carey, B. J.;Michaels, S.;Montez, M. G.;Nathan, D. M.;Nyenwe, E.;Patricio, J.;Peters, A.;Pi-Sunyer, X.;Pownall, H.;Wadden, T. A.;Wagenknecht, L. E.;Williamson, D. F.;Wing, R. R.;Wyatt, H.;Yanovski, S. Z.

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行为减肥干预对糖尿病并发症的长期影响尚不清楚。我们在Look AHEAD中评估了强化生活方式干预(ILI)是否会影响肾病的发展,这是一项针对2型糖尿病的多中心随机临床试验。将5145名45-76岁的超重或肥胖2型糖尿病患者随机分配至ILI组或糖尿病支持和教育(DSE)组,ILI旨在通过减少热量消耗和增加体力活动来实现和维持体重减轻。在基于网络的中央数据管理系统中以1:1的比例随机分配至ILI或DSE,按临床中心分层,并使用随机区组大小进行区组化。结果评估员和实验室工作人员对治疗设盲。由于对心血管疾病事件的主要结局缺乏影响,干预措施提前结束。白蛋白尿和估计的肾小球滤过率是预先指定的“其他”结果,并从基线到9.6年(中位数)随访直至干预结束进行评估。将其事后合并以定义本报告的主要结局:基于2013年肾脏病改善全球结局分类的极高危慢性肾脏病(CKD)。数据按意向治疗进行分析。该试验注册为Clinicaltrials.gov NCT 00017953。ILI中极高危CKD的发生率比DSE低31%,DSE和ILI中的风险率分别为0.90例/100人-年和0.63例/100人-年(差异=0.27例/100人-年,风险比和95%置信区间:HR=0.69,0.55 - 0.87)。这种效应部分归因于体重、HbA 1c和血压的降低。体重减轻应被视为药物治疗的辅助手段,以预防或延缓超重或肥胖的2型糖尿病患者的CKD进展。国家糖尿病、消化和肾脏疾病研究所。
Long-term effects of behavioral weight loss interventions on diabetes complications are unknown. We assessed whether an intensive lifestyle intervention (ILI) affects the development of nephropathy in Look AHEAD, a multicenter randomized clinical trial in type 2 diabetes. 5145 overweight or obese persons aged 45–76 years with type 2 diabetes were randomized to ILI designed to achieve and maintain weight loss through reduced caloric consumption and increased physical activity or to a diabetes support and education (DSE) group. Randomization to ILI or DSE, in a 1:1 ratio, was implemented in a central web-based data management system, stratified by clinical center, and blocked with random block sizes. Outcomes assessors and laboratory staff were masked to treatment. The interventions ended early because of lack of effect on the primary outcome of cardiovascular disease events. Albuminuria and estimated glomerular filtration rate were prespecified “other” outcomes and were assessed from baseline through 9.6 years (median) of follow-up until the interventions ended. They were combined post-hoc to define the main outcome for this report: very-high-risk chronic kidney disease (CKD) based on the 2013 Kidney Disease Improving Global Outcomes classification. Data were analyzed by intention to treat. The trial is registered as Clinicaltrials.gov NCT00017953. The incidence rate of very-high-risk CKD was 31% lower in ILI than DSE with hazard rates of 0.90 cases/100 person-years in DSE and 0.63 in ILI (difference=0.27 cases/100 person-years, hazard ratio and 95% confidence interval: HR=0.69, 0.55 to 0.87). This effect was partly attributable to reductions in weight, HbA1c, and blood pressure. Weight loss should be considered as an adjunct to medical therapies to prevent or delay progression of CKD in overweight or obese persons with type 2 diabetes. National Institute of Diabetes and Digestive and Kidney Diseases.