University of Iowa News Release
April 17, 2003
Study Will Test Disease Prevention In Adults With Type 2 Diabetes
University of Iowa Health Care is one of 70 centers 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). The National Institute on Diabetes and Digestive and Kidney Diseases (NIDDK), another part of NIH, is providing additional support for the study.
Currently, approximately 200,000 people in the region served by University of Iowa Health Care have Type 2 diabetes, a condition that is closely linked to obesity. The disorder places people diagnosed with the disease at a greater risk of cardiovascular disease (CVD). People with Type 2 diabetes die of CVD at rates two to four times higher than those who do not have diabetes. They also experience more nonfatal heart attacks and strokes.
"There is a great need to determine the best way to prevent heart disease and stroke caused by diabetes," said William Sivitz, M.D., UI professor of internal medicine and a study investigator. Greg Doelle, M.D., Udaya Kabadi, M.D., and Robert Spanheimer, M.D., from the endocrinology division of the UI Department of Internal Medicine, will join Sivitz in this research study.
Type 2 diabetes, previously called adult onset or non-insulin dependent diabetes mellitus, is a disorder in which 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 those from ethnic minorities. African-Americans, Hispanic/Latino Americans, Native Americans (First Nation in Canada) and some Asian and Pacific Islander Americans are at a particularly high risk for Type 2 diabetes.
ACCORD is being conducted in Diabetes Clinical Research and Programs at UI Hospitals and Clinics. Researchers are seeking 185 adults with Type 2 diabetes. In addition to blood sugar, other CVD factors that will be closely controlled in the ACCORD study are high blood pressure, high blood fats (cholesterol and triglycerides) and insulin resistance. The study is expected to run 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 (blood fats). ACCORD 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 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. 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 (less than 120mmHg systolic) will reduce CVD risk better compared to a usual target level in current clinical practice, i.e., below the definition of hypertension (less than 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. All ACCORD participants will receive their blood sugar treatment from the study. Based on the additional part of the trial they are assigned to, participants will also receive their cholesterol or high blood pressure care from the study. Study participants will receive a blood glucose monitor and necessary supplies, as well as all medication and treatments related to the study, free of charge. Patients who are selected and consent to participate in the ACCORD study will continue to see their personal physician for all their other health care.
For more information, call Sheila Wayson, nurse clinician and trial coordinator, toll free at (877) 807-9590 or at (319) 356-4879 and ask about the ACCORD study.
University of Iowa Health Care describes the partnership between the UI Roy J. and Lucille A. Carver College of Medicine and UI Hospitals and Clinics and the patient care, medical education and research programs and services they provide. Visit UI Health Care online at www.uihealthcare.com.
STORY SOURCE: Joint Office for Planning, Marketing and Communications, University of Iowa Health Care, 200 Hawkins Drive, Room 8798 JPP, Iowa City, Iowa 52242-1009
CONTACT(S): Tom Moore, 319-356-3945, email@example.com.