ACCORD Study Looks at Best Ways to Lower Risk of Heart Disease and Stroke in Adults with Type-2 Diabetes

The UC Medical Center and Cincinnati Veterans Affairs (VA) Medical Center are running one of the 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 National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), funds the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study. The National Institute on Diabetes and Digestive and Kidney Diseases, also part of the NIH, is providing additional support to the study.

According to 1999 figures from the Cincinnati American Diabetes Chapter, about 507,054 adults in Ohio (or 6.1 percent) have type-2 diabetes, a condition that is closely linked to obesity and places people who have the disease at greater risk of cardiovascular disease. People with type-2 diabetes die of heart disease or stroke at rates two to four times higher than those who do not have diabetes. They also experience more nonfatal heart attacks and strokes. “This is particularly true in the Cincinnati Tristate, with the high frequency of obesity in Ohio, Kentucky and Indiana,” said Robert M. Cohen, MD, associate professor of medicine, UC Department of Internal Medicine/Endocrinology and the principal investigator for the study locally.

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.  Type-2 diabetes 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, and some Asian Americans and Pacific Islanders are at particularly high risk for type-2 diabetes.

ACCORD is being conducted in one clinic in the Cincinnati/Northern Kentucky/ Southwestern Indiana area and is seeking 145 adults with type-2 diabetes. In addition to blood sugar, other heart disease risk factors that will be aggressively controlled in the ACCORD study are high blood pressure, high blood fats, and insulin resistance. The study will be conducted 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, MD. “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. 

The ACCORD study will test three 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 the risk of cardiovascular disease.  The study will determine whether the new lower level of blood sugar is more beneficial in preventing heart disease than the level that is currently suggested.*Blood pressure. Many people with type-2 diabetes have high blood pressure.  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 stroke and heart disease 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 greater Cincinnati study will receive all their blood sugar treatment from Dr. Cohen and Barbara Ramlo-Halsted, MD, assistant professor in the UC Department of Internal Medicine/Endocrinology. Both physicians are diabetes specialists at UC, the Cincinnati VA Medical Center and University Internal Medicine Associates.  Participants will be assigned to either an intensive or standard blood sugar treatment group, and will receive either cholesterol or high blood pressure treatment from the study doctors.

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. For more information, call (513) 861-3100 ext. 4431 or call 1-800-320-2833.

***NHLBI is part of the National Institutes of Health (NIH), the 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

.