BIDMC Administrative Core

在推荐范围内饮酒对心血管疾病、糖尿病和相关疾病风险的影响是 也许是酒精、营养或预防领域中最重要的问题。 全世界大约一半的成年人报告目前或以前饮酒， 迫切需要澄清酒精对他们健康构成的风险。流行病学研究表明， 发现在推荐范围内的酒精摄入量与较低的冠心病风险有关， 缺血性中风和糖尿病，但没有长期的随机试验，酒精消费的风险，任何慢性 疾病还没有被发现。直接回应PAR-16-363（多中心随机对照临床试验） 酒精对健康影响的试验研究中心），我们提出了一个全球性的，六年，平衡设计 一项随机试验，比较每天一份标准量（约14克）酒精摄入量与 在高于平均水平的7，800名成年人中对CVD，糖尿病，死亡率和相关结果的风险进行了评估 全球心血管风险为了最大限度地提高可行性并最密切地反映实际使用情况，我们建议测试 酒精消费本身，以避免，从而为参与者提供灵活性，在他们的饮料选择， 同时采用新颖且密集但有效的方法来监测安全性。这主要的具体目的 这项试验旨在确定每天摄入14克酒精与戒酒相比对主要疾病风险的影响。 心血管事件或死亡（心肌梗死、缺血性卒中、住院心绞痛、需要 在7，800名年龄≥50岁的成人中，平均随访6年， 估计10年CVD风险≥15%或在入组前6个月患CVD。次要目标将测试 酒精对糖尿病和主要心血管事件风险的影响。三级目标将测试风险 严重心血管事件和进展为空腹血糖受损。与其他大型随机化 试验，我们将在全球范围内建立约16个中心，采用分步方法，为期9个月的先锋阶段 美国、欧洲、非洲和南美洲的7家中心（在本申请中），随后是第二波 完成入组。将在多个补充方案中监测受试者的安全性 这些方法包括简要的电子实时报告和经验证的年度仪器和实验室措施。 我们汇集了美国和欧洲非常成功的团队，以建立临床、数据和 我们的现场中心包括许多最有经验的临床试验专家， 我们的团队与NIAAA和其他NIH工作人员建立了牢固的工作关系， 在U10资助的合作研究奋进中进行无缝协作。在本申请中，我们提出 第一个关于酒精消费的随机临床试验，旨在确定它是增加还是减少 全球心血管风险高于平均水平的成年人的心血管疾病和糖尿病风险。

The effects of drinking alcohol within recommended limits on risks of CVD, diabetes, and related diseases are perhaps the most important questions yet to be answered in the fields of alcohol, nutrition, or prevention. Approximately half of all adults worldwide report current or former alcohol consumption, and the benefits or risks that alcohol poses to their health urgently need clarification. Epidemiological studies have consistently found that alcohol intake within recommended limits is associated with lower risk of coronary heart disease, ischemic stroke, and diabetes, yet no long-term randomized trial of alcohol consumption on risk of any chronic disease has yet been performed. In direct response to PAR-16-363 (Multi-Site Randomized Controlled Clinical Trial Research Center on Alcohol's Health Effects), we propose a worldwide, six-year, balanced-design randomized trial, comparing the effects of one standard serving (~14 grams) of alcohol intake daily to abstention on risk of CVD, diabetes, mortality, and related outcomes among 7,800 adults at above-average cardiovascular risk worldwide. To maximize feasibility and reflect actual use most closely, we propose to test alcohol consumption per se to abstention and thus to offer participants flexibility in their choice of beverage, while employing novel and intensive yet efficient methods to monitor safety. The Primary Specific Aim of this trial is to determine the effects of 14 gm of alcohol intake daily compared with abstention on risk of major cardiovascular events or death (myocardial infarction, ischemic stroke, hospitalized angina, need for revascularization, or death) over an average of 6 years of follow-up among 7,800 adults aged ≥50 years with estimated 10-year CVD risk ≥15% or prevalent CVD >6 months prior to enrollment. Secondary Aims will test the effects of alcohol on risks of incident diabetes and major cardiovascular events. Tertiary Aims will test risks of hard cardiovascular events and progression to impaired fasting glucose. Similar to other large randomized trials, we will establish ~16 centers worldwide using a stepped approach, with a 9-month vanguard phase among 7 centers in the US, Europe, Africa, and South America (in this application), followed by a second wave of additional sites to complete enrollment. Participants will be monitored for safety in multiple complementary ways, including brief electronic real-time reporting and validated yearly instruments and laboratory measures. We have brought together highly successful groups in the US and Europe to establish clinical, data, and biospecimen coordinating centers, our field centers include many of the most experienced clinical trialists anywhere, and our group has strong working relationships with NIAAA and other NIH staff necessary to ensure seamless collaboration during a U10-funded cooperative research endeavor. In this application, we propose the first randomized clinical trial of alcohol consumption, aiming to determine whether it increases or decreases the risk of CVD and diabetes among adults at above-average cardiovascular risk worldwide.