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 with type 2 diabetes mellitus die of cardiovascular disease (CVD) at rates two to four times higher than non-diabetic populations of similar demographic characteristics. They also experience increased rates of nonfatal myocardial infarction and stroke. With the growing prevalence of obesity in the United States, CVD associated with type 2 diabetes is expected to become an even greater public health challenge in the coming decades than it is now. Expected increases in event rates will be associated with a concomitant rise in suffering and resource utilization. Despite the importance of this health problem in the North American population, there is a lack of definitive data on the effects of intensive control of glycemia and other CVD risk factors on CVD event rates in diabetic patients. The overall goal of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial is to address this challenge by testing three complementary medical treatment strategies for type 2 diabetes to enhance the options for reducing the still very high rate of major CVD morbidity and mortality in this disease. The design is a randomized, multicenter, double 2 X 2 factorial design in 10,000 patients with type 2 diabetes mellitus. The trial is designed to test the effects on major CVD events of intensive glycemia control, of treatment to increase HDL-cholesterol and lower triglycerides (in the context of good LDL-C and glycemia control), and of intensive blood pressure control (in the context of good glycemia control). All 10,000 participants will be in the overarching glycemia trial. In addition, one 2 X 2 trial will also address the lipid question in 5,800 of the participants and the other 2 X 2 trial will address the blood pressure question in 4,200 of the participants. The three specific primary ACCORD hypotheses are as follow. In middle-aged or older people with type 2 diabetes who are at high risk for having a cardiovascular disease (CVD) event because of existing clinical or subclinical CVD or CVD risk factors: (1) does a therapeutic strategy that targets a HbA1c of <6.0% reduce the rate of CVD events compared to a strategy that targets a HbA1c of <7.5% ? (2) does a therapeutic strategy that raises HDL-C and lowers triglyceride levels in the context of desirable levels of LDL-C and good glycemic control reduce the rate of CVD events compared to a strategy that only achieves desirable levels of LDL-C and glycemic control? (3) In the context of good glycemic control, does a therapeutic strategy that targets a systolic blood pressure (SBP) of <120 mm Hg reduce the rate of CVD events compared to a strategy that targets a SBP of <140 mm Hg? The primary outcome measure for the trial is the first occurrence of a major cardiovascular disease event, specifically nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. The ACCORD study is designed to have: + 92% power to detect a 15% treatment effect of intensive glycemic control compared with conventional glycemic control, + 90% power to detect a 20% treatment effect of lipid control through LDL-C lowering and fibrates compared with lipid control using LDL-C lowering alone, + 90% power to detect a 20% treatment effect of intensive blood pressure control compared with conventional blood pressure control. Secondary hypotheses include treatment differences in other cardiovascular outcomes, total mortality, microvascular outcomes, health-related quality of life, and cost-effectiveness. The 10,000 participants will be treated and followed for 4 to 8 years (approximate mean of 5.6 years) at approximately 60 Clinical Sites administratively located within 7 Clinical Center Networks in the United States and Canada. Recruitment will occur in two non-contiguous periods: an initial period beginning in January 2001 in the Vanguard Phase of the trial and then a subsequent period beginning in May 2002 (after review of the vanguard data) and ending in September 2004. Follow-up is scheduled to end in September 2008, with the primary results announced by the end of 2009.
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