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首页> 外文期刊>Diabetes care >XENical in the Prevention of Diabetes in Obese Subjects (XENDOS) Study: A randomized study of orlistat as an adjunct to lifestyle changes for the prevention of type 2 diabetes in obese patients.
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XENical in the Prevention of Diabetes in Obese Subjects (XENDOS) Study: A randomized study of orlistat as an adjunct to lifestyle changes for the prevention of type 2 diabetes in obese patients.

机译:XENical在预防肥胖受试者中的糖尿病(XENDOS)研究:奥利司他作为生活方式改变的辅助物在肥胖患者中预防2型糖尿病的随机研究。

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摘要

OBJECTIVE:-It is well established that the risk of developing type 2 diabetes is closely linked to the presence and duration of overweight and obesity. A reduction in the incidence of type 2 diabetes with lifestyle changes has previously been demonstrated. We hypothesized that adding a weight-reducing agent to lifestyle changes may lead to an even greater decrease in body weight, and thus the incidence of type 2 diabetes, in obese patients. RESEARCH DESIGN AND METHODS-In a 4-year, double-blind, prospective study, we randomized 3,305 patients to lifestyle changes plus either orlistat 120 mg or placebo, three times daily. Participants had a BMI >/==" BORDER="0">30 kg/m(2) and normal (79%) or impaired (21%) glucose tolerance (IGT). Primary endpoints were time to onset of type 2 diabetes and change in body weight. Analyses were by intention to treat. RESULTS:-Of orlistat-treated patients, 52% completed treatment compared with 34% of placebo recipients (P < 0.0001). After 4 years' treatment, the cumulative incidence of diabetes was 9.0% with placebo and 6.2% with orlistat, corresponding to a risk reduction of 37.3% (P = 0.0032). Exploratory analyses indicated that the preventive effect was explained by the difference in subjects with IGT. Mean weight loss after 4 years was significantly greater with orlistat (5.8 vs. 3.0 kg with placebo; P < 0.001) and similar between orlistat recipients with impaired (5.7 kg) or normal glucose tolerance (NGT) (5.8 kg) at baseline. A second analysis in which the baseline weights of subjects who dropped out of the study was carried forward also demonstrated greater weight loss in the orlistat group (3.6 vs. 1.4 kg; P < 0.001). CONCLUSIONS:-Compared with lifestyle changes alone, orlistat plus lifestyle changes resulted in a greater reduction in the incidence of type 2 diabetes over 4 years and produced greater weight loss in a clinically representative obese population. Difference in diabetes incidence was detectable only in the IGT subgroup; weight loss was similar in subjects with IGT and or NGT.
机译:目的:-众所周知,发展为2型糖尿病的风险与超重和肥胖的存在和持续时间密切相关。先前已证明,随着生活方式的改变,2型糖尿病的发病率会降低。我们假设在肥胖症患者的生活方式改变中添加减重剂可能导致体重进一步下降,进而导致2型糖尿病的发生。研究设计和方法-在一项为期4年的双盲,前瞻性研究中,我们将3,305例患者的生活方式改变加奥利司他120 mg或安慰剂随机分组,每天3次。参与者的BMI> / ==“ BORDER =” 0“> 30 kg / m(2),并且葡萄糖耐量(IGT)正常(79%)或受损(21%),主要终点是2型糖尿病的发作时间。结果:-奥利司他治疗的患者完成治疗的比例为52%,而安慰剂接受者为34%(P <0.0001);治疗4年后,糖尿病的累积发病率安慰剂组为9.0%,奥利司他组为6.2%,风险降低了37.3%(P = 0.0032)。探索性分析表明,预防作用是由IGT受试者的差异来解释的,4年后的平均体重减轻显着基线时体重(5.7 kg)或糖耐量正常(NGT)正常(NGT)(5.8 kg)的奥利司他接受者之间的相似性更高(奥利司他(5.8 vs. 3.0千克,安慰剂; P <0.001)),并且基线时的基线体重为退出研究的受试者也被证明体重更大奥利司他组的oss(3.6 vs. 1.4 kg; P <0.001)。结论:与单独的生活方式改变相比,奥利司他加生活方式的改变导致4年内2型糖尿病的发病率降低更多,并且在临床上具有代表性的肥胖人群中体重减轻更大。仅在IGT亚组中可检测到糖尿病发生率的差异; IGT和/或NGT患者的体重减轻相似。

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