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September 9, 2002


NIH-Funded Trial Allows Emory Researchers to Study Treatment Options for Diabetics with Coronary Artery Disease

Coronary artery disease (CAD) is a major complication and the leading cause of premature death among people with diabetes, according to both the American Diabetes Association and the American College of Cardiology. So why is there such a strong association between the two conditions? And are medical therapies now being provided for people who suffer from both conditions adequate? Emory University researchers have recently begun a new study to address these questions.

"For some time now, medical literature has suggested that high insulin levels are associated with abnormal blood vessel structure and function," says Suzanne Gebhart, M.D., professor of medicine in the division of endocrinology, Emory University School of Medicine and co-investigator of this study. "Insulin promotes growth of endothelial cells, cells which line blood vessels. Extra insulin in the body could mean extra cell growth in the blood vessels. This, in turn, may cause atherosclerosis (hardening of the arteries) and lead to the progression of coronary artery disease. However, elevated blood sugar as a result of too little insulin is clearly harmful, as well," Dr. Gebhart explains.

Funded by the National Institutes of Health (NIH), this new multi-center, multi-million dollar trial, called Bypass Angioplasty Revascularization Investigation 2 Diabetes or BARI 2D, will enroll participants who have previously been diagnosed with both CAD and Type 2 diabetes. Type 2 diabetes is described as a condition where the body develops a resistance to insulin even though the pancreas may continue to manufacture insulin. Nationwide, 4800 participants will be enrolled.

Participants in this five-year study will be randomly selected by computer to receive a treatment for CAD and a treatment for Type 2 diabetes. In the CAD treatment arm of the study, participants will be randomized to receive angioplasty and medical therapy, bypass surgery and medical therapy or medical therapy alone. In the diabetes treatment arm, participants will randomly receive insulin promoting drugs, which increase insulin, or insulin sensitizing drugs, which enhance a person's own insulin.

"At any time during the study, participants who need a more aggressive treatment for their heart disease may cross over to angioplasty or bypass surgery," says John Douglas, M.D., professor of medicine in the division or cardiology, Emory University School of Medicine and co-investigator of the trial. "No one will be denied necessary therapy because they've been selected for one group over another."

A previous BARI 1 (Bypass Angioplasty Revascularization Investigation 1) study showed that diabetics with CAD who underwent either angioplasty or bypass surgery did not fare as well as non-diabetes who underwent the same procedures. But the reasons why were unclear. "As a result of the BARI 1 study, our focus now is on the diabetic population with coronary artery disease," Dr. Gebhart states. "Since little research has been done on the connection between insulin and coronary artery disease, we hope the BARI 2D study will help us pinpoint why the outcomes of diabetics following intervention seem to be worse."

Coronary artery disease in the diabetic population is frequently silent and deadly. "CAD screening is so important in diabetics since it often goes unrecognized," Dr. Douglas points out. "Because diabetics' nerves are often affected by the disease, they have less sensation of pain and may be less likely to recognize chest pain – an important indicator of heart disease."

Participants must first undergo a stress test to determine if they qualify for this trial. Those who have positive stress test results will then undergo a heart catheterization to find out if they have a blocked or narrowed artery. Once selected to participate in the trial, participants will receive regular cardiology exams. Every month for the first six months of the trial, participants will also be seen by the endocrinology staff with the aim of achieving optimal management of their diabetes. Afterwards, they will be followed every three months for the duration of the trial.

Recruitment is underway for this study. Participants must be 25 years of age or older, with Type 2 diabetes and stable CAD. Those who have had angioplasty longer than one year ago can enroll in this trial, as can participants who have undergone previous bypass surgery. Participants in this study must also be willing to turn certain aspects of their medical management over to Emory doctors throughout the duration of this study, since endocrinologists and cardiologists involved in this study must be BARI 2D certified. For more information or to find out if you are eligible for this trial, please contact Emory Health Connection at (404) 778-7777.

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