BARI 2D: BYPASS ANGIOPLASTY REVASCULARIZATION INVESTIGATION 2 DIABETES

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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.