Planning Grant for a Multi Center RCT of Moderate Alcohol Use on Chronic Disease

适度饮酒治疗慢性病的多中心随机对照试验计划拨款

基本信息

批准号：
8757476
负责人：
KENNETH Jay MUKAMAL
金额：
$ 46.96万
依托单位：
BETH ISRAEL DEACONESS MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-03-20 至 2016-02-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8757476
关键词：
Accidents Adherence Adult Affect Africa Alcohol abuse Alcohol consumption Alcoholism Alcohols Animals Area Asia Atherosclerosis Benefits and Risks Beverages Biological Bone Density Breast Cardiovascular Diseases Cardiovascular system Cholelithiasis Chronic Disease Clinical Clinical Trials Clinical Trials Design Clinical trial protocol document Collaborations Congestive Heart Failure Coronary heart disease Data Development Development Plans Diabetes Mellitus Disease Documentation Effectiveness Elderly Ensure Epidemiologic Studies Epidemiologist Equilibrium Estrogen Therapy Estrogens Ethanol Europe Face Fibrinogen Fracture Future Goals Gold Grant Health Health Care Seeking Behavior Health Status High Density Lipoprotein Cholesterol Human Hypertension Influentials Institutional Review Boards Insulin Resistance Intake International Intervention Ischemic Stroke Link Malignant Neoplasms Manuals Methods Monitor Myocardial Infarction National Institute on Alcohol Abuse and Alcoholism Neurobiology North America Nutritional Observational Study Outcome Outpatients Participant Pathway interactions Patients Pattern Phase Physicians Postmenopause Preparation Protocols documentation Psychiatrist Randomized Randomized Clinical Trials Recommendation Recruitment Activity Research Infrastructure Research Personnel Residual state Risk Safety Scientist Site Specimen Stroke Testing Trauma U-Series Cooperative Agreements Woman Women&apos s Health Work adiponectin adjudicate alcohol epidemiology alcohol risk cardiovascular disorder risk cardiovascular risk factor clinical practice clinical research site cost data management design disorder prevention drinking experience feeding high risk drinking improved international center malignant breast neoplasm meetings men middle age mortality novel operation preference public health relevance randomized trial repository research study response sex success

项目摘要

DESCRIPTION (provided by applicant): Moderate or low-risk alcohol consumption (defined by NIAAA as d4 drinks on any single day AND d14 drinks per week for men or d3 drinks on any single day AND d7 drinks per week for non-pregnant women) has been associated - despite its appellation - with a wide variety of health outcomes of the greatest import. Compared with abstainers or rare drinkers, moderate drinkers have been observed to have lower rates of coronary heart disease, congestive heart failure, ischemic stroke, diabetes, and cholelithiasis but higher rates of breast and possibly other cancers; relationships with fractures are less certain, although evidence suggests that moderate alcohol may simultaneously raise risk of trauma yet improve bone density. Perhaps most compellingly, moderate alcohol intake has been associated with a lower risk of all-cause mortality, chiefly reflecting its inverse associatio with cardiovascular mortality. Important limitations affect this body of evidence, however. Although large and consistent epidemiological studies have been conducted, strong concerns about residual confounding by both health status and health- seeking behavior exist. The existing experimental studies of alcohol are small and short and, while demonstrating plausible mechanisms by which moderate drinking would lower cardiometabolic risk, the lack of correspondence between similar studies of postmenopausal estrogen treatment and the randomized Women's Health Initiative clinical trial only heightens this concern. Given the widespread use of alcohol, the clear risks and costs of its overuse, the uncertain balance of risks and benefits of moderate use, and the complete lack of definitive clinical trial data, the urgent need for a clinical trial of moderate alcohol intake is unmistakable. In this Clinical Trial Planning Cooperative Agreement (U34) application, we propose to develop a multi-center, international, long-term, pragmatic randomized clinical trial of moderate drinking on the key clinical outcomes with which it has been associated - cardiovascular disease, cancer, diabetes, trauma, accidents, mortality, and progression to heavy or at-risk drinking. Building upon a team of established investigators and field centers with clinical trial and/or alcohol expertise (both i most cases) in North America, Asia, Europe, and Africa, we intend to develop a clinical trial protocol, recruit additional field centers, establish a data management network, and outline practical strategies for recruitment, intervention, monitoring, and outcome ascertainment across diverse settings. With a focus upon adults at higher cardiovascular risk to maximize efficiency, we will partner with NIAAA to develop a definitive clinical trial that can provide patients and clinicians worldwide with gold- standard advice about the effectiveness of moderate drinking in chronic disease prevention.

描述（由申请人提供）：中等或低风险的酒精消耗（由NIAAA定义为任何一天的D4饮料，男性每天为D14饮料，或每天的D3饮料，而每周的D3饮料和D7饮料每周都与非孕妇的D7饮料有关） - 尽管有多种选择，但仍有各种各样的健康状况。与戒酒者或稀有饮酒者相比，已经观察到适度的饮酒者患冠状动脉疾病，充血性心力衰竭，缺血性中风，糖尿病和胆石症患者，但乳腺癌的发生率较高，可能是其他癌症。与骨折的关系不确定，尽管有证据表明中度酒精可能会同时增加创伤的风险，但可以改善骨密度。也许最引人注目的是，中度的酒精摄入量与全因死亡率的风险较低有关，主要反映了其与心血管死亡率的逆相关性。但是，重要的局限性影响了这一证据体系。尽管已经进行了大量且一致的流行病学研究，但仍存在对健康状况和寻求健康行为的残留混淆的强烈关注。现有的对酒精的实验研究小而短，同时证明了合理的机制，中等饮酒会降低心脏代谢风险，但绝经后雌激素治疗的类似研究与随机妇女健康临床临床试验之间缺乏对应关系，只会使这种关注度更高。鉴于酒精的广泛使用，其过度使用的明显风险和成本，中等使用的风险和收益的不确定平衡以及完全缺乏确定的临床试验数据，因此迫切需要对中度酒精摄入的临床试验毫无疑问。在这项临床试验中规划合作协议（U34）的申请，我们建议开发一种多中心，国际，长期的，务实的随机临床试验，对与之相关的关键临床结局进行了适度的饮酒，心血管疾病，癌症，糖尿病，创伤，创伤，死亡，死亡，死亡，死亡率以及对饮酒量或饮酒。我们打算在北美，亚洲，欧洲和非洲拥有临床试验和/或酒精专业知识的成熟研究人员和现场中心的基础上，我们打算制定临床试验方案，招募额外的现场中心，建立数据管理网络，并跨越了跨多种设置的招聘，介入，监测和结果确定性的实用策略。我们将着重于具有较高心血管风险以最大化效率的成年人，我们将与NIAAA合作，开发一项确定的临床试验，该试验可以为全世界的患者和临床医生提供有关适度饮酒在慢性疾病预防中的有效性的金标准建议。