NEWS

UNC in major study to test best ways to lower heart disease, stroke risk in type 2 diabetes

CHAPEL HILL -- The University of North Carolina at Chapel Hill is one of 70 clinics nationwide and in Canada taking part in a major new study to test three promising approaches to lowering heart disease and stroke risk in adults with type 2 diabetes.

The Action to Control Cardiovascular Risk in Diabetes, or ACCORD, study is funded by the National Heart, Lung, and Blood Institute, part of the National Institutes of Health. The National Institute of Diabetes and Digestive and Kidney Diseases, another component of the NIH, is providing additional support.

"This study is the largest diabetes study ever conducted in the United States," said Dr. John Buse, ACCORD vice-chairman and associate professor of medicine at UNC.

The study will involve approximately 10,000 people, 10 percent of whom will be recruited in North Carolina, he said. ACCORD is being conducted at the UNC Diabetes Care Center, where 25 people have been treated under this protocol during the last two years and an additional 100 people with type 2 diabetes will be recruited during the next two years.

The study is expected to continue until June 2009. Most participants can expect their involvement to last from five and one-half years to eight and one-half years.

"We hope to examine what are the appropriate blood sugar control targets, blood pressure control targets and cholesterol targets to reduce the risk of heart attack and stroke in people with diabetes," Buse said. "Arguably, these are the most important clinical questions that doctors have; namely, how aggressively should we really treat people with diabetes."

Buse, who directs the UNC Diabetes Care Center, said diabetes is among the leading public health problems in the state. "North Carolina is part of the ‘diabetes-heart-attack-stroke belt’ that runs through the Southeast, affecting vast numbers of people with serious morbidity."

Currently, about 500,000 North Carolinians have type 2 diabetes, previously called adult onset or non-insulin-dependent diabetes mellitus, a disorder in which the muscle and fat cells do not use insulin properly.

ACCORD will determine whether lowering blood glucose to a goal closer to normal than called for in current guidelines reduces cardiovascular disease risk associated with the condition.

"The studies we’ve done to date indicate that an index of average blood sugars in the low-to-mid-100s is associated with better outcomes than higher numbers," Buse said.

Many people with type 2 diabetes have high blood pressure, and one part of the trial will determine the effects of lowering blood pressure in the context of good blood sugar control.

In addition, many people with diabetes have high levels of LDL, the so-called "bad" cholesterol, and triglycerides, as well as low levels of HDL, or "good," cholesterol. ACCORD participants selected for this part of the trial will be assigned to an intervention that improves blood fat levels.

This study component 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 UNC Diabetes Care Center study will be assigned to a glycemia study group and receive all their blood sugar treatment from Buse and the center’s staff. They also will be assigned to the cholesterol study or the blood pressure study and receive their cholesterol or high blood pressure care, as well.

ACCORD study participants will receive all medication and treatments related to the study at no charge and will continue to see their personal doctor for all their other health care needs.

"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 National Heart, Lung, and Blood Institute director Dr. Claude Lenfant.

"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."

People who have the condition die of cardiovascular disease at rates two to four times higher than those who do not have diabetes. Type 2 diabetes also increases an individual’s risk of nonfatal heart attacks and strokes, studies indicate.

Type 2 diabetes is associated with older age, obesity, a sedentary lifestyle and a family history of the condition. Blacks, Hispanics, American Indians, Asians and Pacific Islanders are at particularly high risk.

Those interested in participating in ACCORD should call (877) 238-4825 or (919) 484-0931 ext. 271 and leave their name, telephone number and the best time to contact them.

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Note: Contact Buse at jbuse@med.unc.edu or via Tonya Pope at (919) 966-2276, ext. 222.

School of Medicine contact: Leslie H. Lang, (919) 843-9687 or llang@med.unc.edu