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Clinical Trials: Diabetes

by Jeff Worley

"We have an epidemic of diabetes in this country, and unless there's a lot more attention paid to this disease, the problem is just going to get worse."

This pronouncement comes from Dennis Karounos, an associate professor in the Division of Endocrinology and Molecular Medicine at UK and the VA Medical Center, who says that the risk is increasing for people with both of the traditional forms of diabetes—type 1 and type 2. Type 1 diabetes, previously called insulin-dependent diabetes mellitus or juvenile-onset diabetes, may account for 5 to 10 percent of all diagnosed cases of diabetes. Type 2 diabetes, previously called non-insulin-dependent diabetes mellitus or adult-onset diabetes, is estimated to account for about 90 to 95 percent of all diagnosed cases.

Karounos explains "previously."

"It used to be we'd hardly ever see a child with type 2 diabetes; now 30 percent of children who have diabetes have type 2, an alarmingly high number."

In 2001, 16.7 million Americans were diagnosed with diabetes, according to a study by the Centers for Disease Control and Prevention published in the Journal of the American Medical Association last December. In 2001, 6.6 percent of Kentuckians were diagnosed with diabetes, a steady percentage climb since 1994.

One reason for this increase, Karounos says, is simple demographics. "Baby boomers are headed right for their 60s and 70s, when people become more prone to developing diabetes because, when we're older, the pancreas produces less insulin," he says.

Karounos came from Baylor University 12 years ago and is director of the diabetes program at UK. He is currently focusing his work on what might be called a hybrid type of diabetes—type 1½, which is also called latent autoimmune diabetes in adults (LADA).

Photo of Dennis KarounosDennis Karounos is testing a vaccine to treat latent autoimmune diabetes in adults, a common but unfamiliar type of adult-onset diabetes. In Kentucky in 2001, 6.6 percent of people in the state had been diagnosed with diabetes, a steady percentage climb since 1994.

"This is a common but unfamiliar type of adult-onset diabetes," he explains. "LADA is a disease like type 1 diabetes in which the body's immune system attacks and destroys insulin-producing cells in the pancreas, decreasing the body's ability to produce insulin."

In testing a vaccine to treat LADA, Karounos is working with James Anderson, a professor in the UK endocrinology and molecular medicine division who has been researching diabetes for nearly 30 years. In this Phase II clinical trial, they are teaming up with researchers at Washington University in St. Louis, and the universities of Colorado, Alabama, and Washington in Seattle.

"In order to tackle the problem of type 1½ diabetes clinically, we started looking around at different therapies that are out there," Karounos says. "Lo and behold, there was a group in Israel using an experimental drug that clearly improved insulin secretion in people who'd just developed type 1 diabetes."

For this UK trial, Karounos initially screened, through a blood sample, potential patients recently diagnosed with type 2 diabetes. He looked for antibodies that indicate the autoimmune form of the disease, and if these antibodies were present, and if the volunteers meet a couple of other criteria, they were invited to join the trial.

The study is "double blind," which means neither the participant nor the physician knows whether the experimental drug is being administered. The 20 participants will get eight injections over two years. Half will get the vaccine; half will get an inactive shot.

As reported in the Lexington Herald-Leader last November, Angela Blythe, a UK pediatric nurse, was one of the first two people enrolled in the UK study. Her blood test found she has the autoimmune form of the disease.

"I hope I never have to get to the point of needing insulin injections," she says. "The trial is a chance to test something that could get rid of this so that I never have to worry about it." About 80 percent of people who have Blythe's type of diabetes eventually need daily insulin shots, Karounos says.

The vaccine has exciting potential, he says. If found to halt the progression of diabetes by protecting the insulin-producing cells of the pancreas, the vaccine could be injected every three to six months—"something like a targeted allergy shot for pancreatic cells," Karounos says.

If successful, the vaccine could eliminate or decrease the need for insulin injections for up to 25 percent of people with adult-onset diabetes—up to 3.2 million Americans.

"We're hoping to prevent people from becoming dependent upon insulin therapy," Karounos says. "Diabetes typically affects a person's quality of life. Right now, there's no cure for diabetes, but with new drugs we will be better able to control it."

For information on how to participate in this clinical trial, call UK's Metabolic Research Group at 859/257-4058.

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