Preventing and Treating CVD in People with Type 2 Diabetes: Clinical Trials

Preventing and Treating CVD in People with Type 2 Diabetes

CVD is the main killer of people with type 2 diabetes. For this reason, the NIH is studying the best strategies to prevent and treat CVD in people with diabetes in three major studies. These studies are all joint efforts of the NIDDK and the National Heart, Lung, and Blood Institute.

The Look AHEAD (Action for Health in Diabetes) trial is the largest clinical trial to date to examine the long-term health effects of voluntary weight loss. This multi-center, randomized clinical trial is studying the effects of a lifestyle intervention designed to achieve and maintain weight loss over the long term through decreased caloric intake and increased exercise. Look AHEAD will focus on the disorder most associated with being overweight or obese, type 2 diabetes, and on the outcome that causes the greatest morbidity and mortality in people with type 2 diabetes, CVD.

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, a multi-center, randomized trial, is studying three approaches to preventing major cardiovascular events in individuals with type 2 diabetes. ACCORD is designed to compare current practice guidelines with more intensive glycemic control in 10,000 individuals with type 2 diabetes, including those at especially high risk for CVD events because of age, evidence of subclinical atherosclerosis, or existing clinical CVD. More intensive control of blood pressure than is called for in current guidelines and a medication to reduce triglyceride levels and raise HDL (good) cholesterol levels will also be studied in subgroups of these 10,000 volunteers. Each treatment strategy will be accompanied by standard advice regarding lifestyle choices, including diet, physical activity, and smoking cessation, appropriate for individuals with diabetes.

The primary outcome to be measured is the first occurrence of a major CVD event, specifically heart attack, stroke, or cardiovascular death. In addition, the study will investigate the impact of the treatment strategies on other cardiovascular outcomes; total mortality; limb amputation; eye, kidney, or nerve disease; health-related quality of life; and cost-effectiveness.

The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial, a 5-year, multi-center clinical trial, is comparing medical versus early surgical management of patients with type 2 diabetes who also have coronary artery disease and stable angina or ischemia. At the same time, BARI 2D will study the effect of two different strategies to control blood glucose—providing insulin versus increasing the sensitivity of the body to insulin—on the risk of cardiovascular mortality and morbidity.

A complete listing of clinical trials can be found at www.ClinicalTrials.gov.