BARI 2D: BYPASS ANGIOPLASTY REVASCULARIZATION INVESTIGATION 2 DIABETES

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 年龄在25岁及以上、经冠状动脉造影证实患有2型糖尿病和冠状动脉疾病的患者，如果不需要血管重建来迅速控制严重或不稳定的心绞痛，则有资格参加试验。正在接受胰岛素或口服降血糖药物治疗的糖尿病患者将与接受饮食和运动治疗的糖尿病患者一样符合条件，前提是糖尿病的诊断可以通过记录或复习得到确认，或者能够获得空腹血糖&gt；126/mg/dl(7.0 mmol/L)。BARI 2D的适宜性将由每个参与机构的一名医生兼研究人员在冠状动脉造影术时根据临床理由做出决定。共有2,600名学员将在32所参与院校报名。 BARI 2D的目标是验证如下两个假设：1)冠状动脉血管重建化假设：与仅采用积极药物治疗的策略相比，最初选择的选择性血管重建化(手术或基于导管)结合积极药物治疗的策略可降低5年死亡率；2)血糖控制假说的方法：在目标糖化水平为7.0%的情况下，针对胰岛素增敏的高血糖管理策略与提供胰岛素的策略相比，可降低5年死亡率。 符合条件的受试者将被要求参加为期五年的治疗，并将被随机分配到以下治疗单位之一： 1)最佳药物治疗和胰岛素提供药物， 2)最佳药物治疗和胰岛素增敏药物， 3)手术或球囊血管重建术加上最佳的药物治疗和胰岛素提供药物 4)手术或球囊血管重建术+最佳的药物治疗和胰岛素增敏药物。 主要的终点将是5年死亡率。次要终点将包括心肌梗死和其他缺血事件的发生率、血糖控制策略的影响和经济成本。 我们已经同意招募50名患者(每年25名)，他们将在6个月内每月就诊一次，然后在剩下的研究中每3个月就诊一次。我们要求使用综合临床研究中心进行这些研究访问。所有随机分组的患者都必须接受GCRC检查，以便： 1)获得病史、体重和血压的测定、采集空腹血样以检测血脂、血糖、糖化血红蛋白、纤溶因子和肝功能， 2)获取尿白蛋白样本并进行检测， 3)记录糖尿病药物， 4)记录治疗高血压和血脂异常的药物， 5)收集合规数据。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Patients age 25 and older with type 2 diabetes and coronary artery disease documented by coronary aarteriography will be eligible for the trail if revascularization is not required for prompt control of severe or unstable angina. Diabetic patients who are being treated with insulin or oral hypoglycemic drugs will be eligible as well as diabetic patients treated with diet and exercise provided that the diagnosis of diabetes can be confirmed by record or review or that fasting plasma glucose >126/mg/dl (7.0 mmol/L) can be obtained. The determination of suitability for BARI 2D will be made by a physician-investigator at each participating institution on clinical grounds at the time of coronary angiography. A total of 2,600 participants are to be enrolled at the 32 participating institutions. The objective of BARI 2D is to test two hypotheses as follows: 1) Coronary Revascularization Hypothesis: a strategy of initial elective revascularization of choice (surgical or catheter-based) combined with aggressive medical therapy results in lower 5-year mortality compared to a strategy of aggressive medical therapy alone; 2) Method of Glycemic Control Hypothesis: with a target HbA1c level of <7.0%, a strategy of hyperglycemia management directed at insulin sensitization results in lower 5-year mortality compared to a strategy of insulin provision. Eligible subjects will be requested to participate for a period of five years and will be randomized to one of the following treatment arms: 1) optimal medical therapy and insulin providing drugs, 2) optimal medical therapy and insulin sensitizing drugs, 3) surgical or balloon revascularization plus optimal medical therapy and insulin providing drugs 4) surgical or balloon revascularization plus optimal medical therapy and insulin sensitizing drugs. The primary end-point will be five-year mortality. Secondary end-points will include rates of myocardial infarction and other ischemic events, effects of glycemnic control strategy and economic costs. We have agreed to enroll 50 patients (25 per year) who are to be seen every month for six months and then every three months for the remainder of the study. We request use of the General Clinical Research Center for these study visits. GCRC visits are mandated for all randomized patients in order to: 1) obtain history of symptoms, determination of body weight and pressure, collection of fasting blood samples for lipids, glucose, HbA1c, fibrinolytic factors, and liver function, 2) obtain samples and measurement of urine albumin, 3) document diabetes medications, 4) document medications for hypertension and dyslipidemia, 5) collect compliance data.