Teens Help Test New Drugs For Diabetes Research At USF, TGH

Sixteen-year-old Robert Colon knew something was wrong when he kept losing weight last winter.

Within a few weeks, he lost 23 pounds.

He was thirsty constantly, too.

 "I could chug three bottles of water and still be thirsty," the Jesuit High School student says. After drinking copious amounts of liquid, he found himself making frequent trips to the bathroom. And, he was tired all of the time.

"I could come home from school, fall asleep at 6 (p.m.) and sleep through the whole night," Colon says. "I had to set my alarm clock so I could get up and do my homework."

On March 1, he was diagnosed with Type 1 diabetes.

Fife says people don't always realize they have diabetes, but she notes that Colon's symptoms -- frequent thirst and sudden weight loss --  are common symptoms of the disease.

Some of the other signs are blurry vision, profuse sweating, or confusion. If blood sugar levels plummet, a coma could occur.

Colon is now part of a clinical trial being conducted by the University of South Florida in conjunction with Tampa General Hospital.

Researchers are studying the effectiveness of Diamyd, an investigational drug that may preserve the body's ability to produce and secrete insulin in people with Type 1 diabetes.

Diabetes is a chronic disease, with elevated and fluctuating levels of glucose in the blood. It is conventionally diagnosed as Type 1 or Type 2.

In Type 1 diabetes, the cells that make insulin are under attack by the body´s own immune system.

Studies have demonstrated that people with diabetes who continue to produce their own insulin have less trouble with low blood sugar and fewer complications from their diabetes than people who no longer make any insulin.
Type 2 diabetes is generally characterized by a decreased sensitivity to insulin.

Working In Good Company

TGH is one of at least 43 clinical sites across the country participating in the DiaPrevent research study. The study includes three other sites in Florida: The Miami Children's Research Institute in Miami, the University of Florida in Gainesville and Nemours Children's Clinic in Jacksonville.

The TGH trial is being led by principal investigator Dr. John I. Malone of the University of South Florida. Both institutions are being paid for their participation, but the study is being funded by private industry and the details of the funding are confidential.

The clinical trial involves patients between the ages of 10 and 20, who have been diagnosed with Type 1 diabetes within the past three months and who pass a screening test.

In this phase of the study, two out of three participants receive the active vaccine, while the remaining participants are given a placebo.

Researchers have found that people who develop Type 1 diabetes have an autoimmune disorder, says Denise Fife, a clinical research nurse at TGH who is working with Malone.

"When you are first diagnosed with diabetes, most children or young adults have what they call a "honeymoon period" where the pancreas is actually still making insulin and functioning to some degree.

"The goal of the trial is to preserve that function as long as we possibly can," Fife says. "Part of research is gathering all of the data on all of the people that we possibly can, so we can figure out if there is a trend, if there is a reason."

Studies have shown that people who are able to continue to produce their own insulin have fewer complications from their diabetes than those who no longer make any insulin, Fife says.

It's important to avoid constant fluctuations in blood glucose levels because those fluctuations are what cause the bad outcomes of diabetes such as neuropathy, blindness and cardiovascular disease, Fife says.

Taking Part In Research

Study participants are asked to visit the clinic eight times over two years for routine exams and to provide blood and urine samples. Some of the visits involve a test to evaluate the body's ability to produce insulin.

The vaccine they receive is injected under the skin. Its active substance is a protein called glutamic acid decarboxylase (GAD).

There are 14 participants in the clinical trial at TGH.

Besides getting free drugs that may potentially help them, the study participants also get a $50 stipend for each visit.

Besides that, Fife says, "they're part of something bigger. They're an intricate piece to the puzzle that we can't solve, so it's important. A lot of them are really excited about being part of that."

Colon realizes that there are no guaranteed benefits from participating in the clinical trial, but he's pleased to be taking part anyway.

"It's a scientific process. It's necessary for understanding it (diabetes)," Colon says.

After all of the data is collected, it will be reviewed by the scientific team to evaluate whether it is felt that the injections are effective. At that point, they may wish to do a follow-up study on the patients, to observe what happens over a longer period of time, Fife says.

Participants are still being accepted for the trial. For more information go to diaprevent.diamyd.com or call Fife at (813) 844-7829.

B.C. Manion is a freelance writer working out of her 1932 bungalow in South Seminole Heights. Comments? Contact 83 Degrees.
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