Diabetes study pivotal

How do you measure the significance of the ACCORD diabetes drug trial in which WSU Spokane researchers are participating — size of the participant field, scope of the problem, eventual impact on the community or individuals? Regardless of how you measure the study, the result is the same — huge.

Size: The study — formally titled Action to Control Cardiovascular Risk in Diabetics — will include 10,000 participants in the U.S. and Canada. Total funding for the Spokane portion of the trial is more than $2 million.

Scope: About 17 million Americans have diagnosed diabetes; more than 90 percent of those have type 2. The number of people with this form of diabetes, formerly known as adult onset or non-insulin dependent diabetes, is growing rapidly. By 2050, the number of Americans with diagnosed diabetes is projected to increase by 165 percent to 29 million, and 27 million of them will have type 2.

Patients with type 2 diabetes mellitus die of cardiovascular disease (CVD) at rates two to four times higher than nondiabetic populations of similar demographic characteristics. They also experience increased rates of nonfatal heart attacks and stroke. With the growing prevalence of obesity in the United States, CVD associated with type 2 diabetes is expected to become an even greater public health challenge in the coming decades.

Regional impact and importance: The ACCORD study is the largest NIH trial ever to involve a Spokane investigator, according to Debbie Weeks, one of the nurse researchers in pharmacotherapy at WSU Spokane who manages the program. Co-investigators Carol Wysham, MD, of Rockwood Clinic, and John White, assistant professor of pharmacotherapy, work with several others on the research team. Weeks and Juliette Kistler serve as nurse researchers, while Susan Kynast-Gales is nutritionist and Linda Kunstmann handles data.

The effect on one person’s life: A patient enrolled in the trial described his shoulder pain to Weeks in one of his early visits. With her experience working with CVD, she recognized the pain as a possible symptom of angina. A week later, he called her from the hospital to say, “You saved my life.” He had undergone open-heart surgery for five occluded blood vessels.

The ACCORD trial is being conducted at 62 sites nationwide. The purpose is to determine the best way to control the indicators of CVD that accompany a soaring epidemic of diabetes. Patients receive either aggressive or standard treatment for their glycemia (high blood sugar), and for either their blood pressure or their blood lipids (cholesterol and triglycerides), to see which of those strategies works best in the context of good blood sugar control.

“Best” treatment for CVD means not only what works in the lab, but what transfers to clinical practice.

“Is it blood sugar control, blood pressure, lipid control — what works for the patient and for the health care practitioners?” said Weeks. “What works best in a research setting may not work as well in clinical practice.”

Patients in the trial receive “one-stop shopping” diabetic care in the WSU Spokane Health Sciences Building. They get full clinical workups at each visit, consult with Kynast-Gales on diet as frequently as needed (rather than being bound by insurance-coverage limits on nutrition consultations), and receive all medications free of charge. They continue to see their regular healthcare practitioners for treatment of other conditions.

Forty-five people have enrolled to date. The target for the Spokane site is 200, with patients enrolling through June 2005. The study will run until 2009, and all patients enrolled will receive this level of health care and medication through the end of the trial.

“We couldn’t have done this study five or six years ago,” said White.“We didn’t have the meds we need to bring blood sugar and blood pressure down. Now we can answer questions that have never been answered for heart disease. This will change the way we treat diabetes in this country.”

White recently received funding for two add-on studies totaling almost $100,000. Diabetes is the leading cause of blindness in the U.S., and one study will track changes in the eye that lead to blindness, with the goal of answering questions about how to save people’s sight.

The other, the MIND (Memory In Diabetes) study, will test the effects of diabetes on cognition. As diabetic patients age, cognitive issues may make it hard to realize the importance of diet, activity and medication compliance, all key to diabetes treatment.

For more information on the study, go to http://www.accordtrial.org.

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