Major Study Will Test Best Ways to Lower Risk of Heart Disease and Stroke in Adults with Type 2 Diabetes
The Royal Victoria Hospital Metabolic Day Center of the McGill University Health Centre (MUHC) is one of 70 clinics in the United States and Canada taking part in a major new study to test three promising approaches to lower the risk of heart disease and stroke in adults with type 2 diabetes.
The Royal Victoria Hospital Metabolic Day Center of the McGill University Health Centre (MUHC) is one of 70 clinics in the United States and Canada taking part in a major new study to test three promising approaches to lower the risk of heart disease and stroke in adults with type 2 diabetes. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study is being funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH, Bethesda MD). The National Institute on Diabetes and Digestive and Kidney Diseases (NIDDK), another part of NIH, is providing additional support to the study.
Currently, about 125,000 people in Montreal have type 2 diabetes, a condition that is closely linked to obesity and increased risk of cardiovascular disease (CVD). Type 2 diabetes patients are at greater risk of dying from CVD and experience more nonfatal heart attacks and strokes than those who do not have diabetes.
"We are particularly concerned by the increasing frequency of type 2 diabetes in young adults which is probably related to decreased physical activity and poor nutrition habits," said Dr. Jean-François Yale, Director of the MUHC Metabolic Day Center.
Type 2 diabetes, previously called adult onset or non-insulin-dependent diabetes mellitus, is a disorder in which the muscle and fat cells do not use insulin properly. It is associated with older age, obesity, and a family history of diabetes. Type 2 diabetes is most common in women with a history of diabetes during pregnancy, people who lead a sedentary lifestyle, and race/ethnicity. African Americans, Hispanic/Latino Americans, American Indians (First Nation in Canada), and some Asian Americans and Pacific Islanders are at particularly high risk for type 2 diabetes.
A total of 132 adults with type 2 diabetes will participate in the Montreal ACCORD study. In addition to blood sugar, other CVD risk factors that will be aggressively controlled in the study include, high blood pressure, high blood fats, and insulin resistance (cholesterol and triglycerides). The study is expected to go from February 2003 until June 2009. Most participants can expect their involvement to last from 5.5 to 8.5 years.
"This is the first large-scale study in patients with diabetes to test the effects of intensively controlling blood sugar along with aggressive control of blood pressure and lipids," said NHLBI Director Claude Lenfant, M.D. "Given the serious consequences of type 2 diabetes, we expect that the ACCORD study will meet its overall goal to address this significant public health challenge," added Dr. Lenfant.
ACCORD will test 3 medical treatment strategies:
Blood sugar. ACCORD will determine whether lowering blood glucose to a goal closer to normal than called for in current guidelines reduces CVD risk. The study will determine effects on CVD of that level compared with a level that is usually targeted.
Blood pressure. Many people with type 2 diabetes have high blood pressure (HBP). The blood pressure part of the trial will determine the effects of lowering blood pressure in the context of good blood sugar control. ACCORD will determine whether lowering blood pressure to normal (<120mmHg systolic) will reduce CVD risk better compared to a usually-targeted level in current clinical practice, i.e., below the definition of hypertension (<140mmHg systolic).
Blood Fats. Many people with diabetes have high levels of LDL ("bad") cholesterol and triglycerides, as well as low levels of HDL ("good") cholesterol. ACCORD participants who are selected for this part of the trial will be assigned to an intervention that improves blood fat levels. This part of the study will look at the effects of lowering LDL cholesterol and blood triglycerides and increasing HDL cholesterol compared to an intervention that only lowers LDL cholesterol, all in the context of good blood sugar control. A drug from a class of drugs called "fibrates" will be used to lower triglycerides and increase HDL cholesterol, whereas a drug from the class of drugs called "statins" will be used to lower the LDL cholesterol.
Patients with type 2 diabetes who volunteer to participate in the ACCORD study will undergo a variety of tests to determine if they are eligible. Participants selected for the study will receive all their blood sugar, as well as cholesterol or blood pressure treatments from Dr. Patrick Doran and Dr. Jean-François Yale at the MUHC. ACCORD study participants will receive all medication and treatments related to the study free of charge. Participants in the ACCORD study will continue to see their personal physician for all their other health care needs.
NHLBI is part of the National Institutes of Health (NIH), the United States Federal Government's primary agency for biomedical and behavioral research. NIH is a component of the U.S. Department of Health and Human Services. NHLBI press releases and other materials including information about high blood pressure, high blood cholesterol, and heart disease, are available online at www.nhlbi.nih.gov. More information about the ACCORD study can be found on the web at www.accordtrial.org. Information about diabetes can be found on the web at www.niddk.nih.gov.