BARI 2D: BYPASS ANGIOPLASTY REVASCULARIZATION INVESTIGATION 2 DIABETES

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 如果不需要血运重建来迅速控制重度或不稳定型心绞痛，则25岁及以上的2型糖尿病和冠状动脉造影记录的冠状动脉疾病患者将有资格参加试验。正在接受胰岛素或口服降糖药物治疗的糖尿病患者以及接受饮食和运动治疗的糖尿病患者将符合条件，前提是糖尿病的诊断可以通过记录或审查确认，或者可以获得空腹血糖>126/mg/dl（7.0 mmol/L）。巴里2D的适用性将由每个参与机构的医生-研究者在冠状动脉造影时根据临床情况确定。共有2，600名参加者将在32所参与机构登记。 巴里2D的目的是检验以下两个假设：1）冠状动脉血运重建假设：首选的初始选择性血运重建策略（手术或基于导管的）与积极的药物治疗组合与单独的积极的药物治疗策略相比导致较低的5年死亡率; 2）糖基化控制假说的方法：当目标HbA 1c水平<7.0%时，与胰岛素供应策略相比，针对胰岛素增敏的高血糖管理策略导致较低的5年死亡率。 合格受试者将被要求参加为期5年的研究，并将被随机分配至以下治疗组之一： 1)最佳的药物治疗和提供胰岛素的药物， 2)最佳的药物治疗和胰岛素增敏药物， 3)手术或球囊血运重建加最佳药物治疗和胰岛素提供药物 4)手术或球囊血管重建加上最佳药物治疗和胰岛素增敏药物。 主要终点是5年死亡率。次要终点将包括心肌梗死和其他缺血性事件的发生率、血糖控制策略的效果和经济成本。 我们已同意入组50例患者（每年25例），在6个月内每月就诊一次，然后在研究的剩余时间内每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视。要求所有随机化患者进行GCRC访视，以便： 1)获得症状史，测定体重和血压，采集空腹血液样本用于血脂、葡萄糖、HbA 1c、纤溶因子和肝功能， 2)获取样本并测量尿白蛋白， 3)记录糖尿病药物， 4)记录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 trial 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.