Wake Forest University School of Medicine has been selected as the national coordinating center for a major study aimed at preventing cardiovascular disease in diabetes. The study will involve 10,000 patients and last at least nine years.
And the school will serve as a clinical center network in the study, coordinating 10 clinics in five states. Two are in Winston-Salem - at the General Clinical Research Center at Wake Forest University Baptist Medical Center and at Reynolds Health Center.
The study will try to determine whether the cardiovascular complications of Type 2 diabetes, also known as adult-onset diabetes, can be reduced through aggressive control of glycemia, or high blood sugar, as well as aggressive control of high blood pressure and high cholesterol levels. Each patient will be followed for at least four years.
The combined value of the two separate contracts with the National Heart, Lung and Blood Institute (NHLBI) totals $22.7 million, one of the largest projects in the school''s history. According to NHLBI, the national cost of the project exceeds $96.7 million.
Robert Byington, Ph.D., professor of public health sciences and head of the Section on Epidemiology, will head the national coordinating center of the study, called Prevention of Cardiovascular Disease in Diabetes Mellitus.
David C. Goff Jr, M.D., Ph.D., associate professor of public health sciences (epidemiology) and internal medicine (general internal medicine), will direct the clinical center network, which will recruit 1,380 of the 10,000 patients in southeastern clinics.
"This is the most important clinical trial ever done addressing the prevention of heart disease in people with diabetes," Goff said. "The results of this trial will affect the treatment of millions of patients with diabetes for decades to come."
In addition to the clinics here, the network will include clinics at the University of North Carolina at Chapel Hill, Duke University Medical Center, Robeson Health Care Corp. in Fairmont, N.C., the Holston Medical Group in Kingsport, Tenn., the Nalle Clinic in Charlotte, the Lexington Clinic in Lexington, Ky., the Richmond Area High Blood Pressure Clinic in Richmond, Va., and Val-Oak Professional Associates in Valdosta, Ga. Six other similar networks canvass the rest of the country.
The study will compare the effectiveness of several drug strategies to control blood sugar. In a randomized clinical trial, two different intensive strategies, using different drugs, will be compared with conventional control of blood sugar. The two intensive drug regimens also will be compared with each other.
And intensive control of blood pressure and of elevated levels of low-density lipoprotein (LDL) cholesterol will be compared with conventional control. Doctors will shoot to lower LDL below 100 in patients without heart disease, to 75 in patients with heart disease.
Diabetes doubles the risk of high blood pressure. Recent recommendations suggest that blood pressure in diabetics be reduced to 130/85 in patients without heart disease, and to 120/80 in patients with heart disease.
Goff said that about 50 percent of the excess heart disease in diabetics can be attributed to other heart disease risk factors, according to a report of a special conference on diabetes sponsored by the National Institutes of Health. That conference recommended a large-scale clinical trial to determine whether glucose control and altering levels of insulin could reduce the risk of heart disease
The study will also determine whether other diabetes complications can be reduced, such as kidney failure, diabetic retinopathy, which can lead to blindness, and foot diseases.
Minority groups, especially African-Americans, Native Americans and Hispanics, will be a special target of the study. "They have a higher burden of diabetes and a higher rate of complications," Goff explained. The Reynolds Health Center clinic will aim at recruiting African- Americans and Hispanics, while the Robeson group will target Native Americans.
Recruiting for the study is expected to begin in late 2000 or early 2001.
Co-investigators with Goff are Jeff Williamson, M.D., M.H.S., assistant professor of internal medicine (gerontology and geriatric medicine), Curt D. Furberg, M.D., Ph.D., professor of public health sciences, and Ronny A. Bell, Ph.D., assistant professor of public health sciences (epidemiology). Tom Y. Thuren, N.D., Ph.D., assistant professor of internal medicine (endocrinology/metabolism), and Carolyn F. Pedley, M.D., assistant professor of internal medicine (general internal medicine), will direct the Winston-Salem clinics.
Joining Byington as co-investigators are Michael E. Miller, Ph.D., and David M. Reboussin, Ph.D., both associate professors of public health sciences (biostatistics), John R. Crouse III, M.D., professor of internal medicine (endocrinology/metabolism) and public health sciences, Roger T. Anderson, Ph.D., associate professor of public health sciences (social sciences and health policy), C. John Chen, Ph.D., assistant professor of public health sciences (social sciences and health policy), and Gregory W. Evans, M.A., research assistant professor of public health sciences (biostatistics).
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