PBRC tests diabetes drug for children

Pennington Biomedical Research Center is launching a study to discover whether children who are pre-diabetic can benefit from a medication that’s been proven effective in treating adults with Type 2 diabetes in Europe.

The development of medications for the prevention and treatment of Type 2 diabetes in children lags far behind that of cancer, blood disorders and other maladies because the problem is relatively new.

Type 2 diabetes used to be considered a potential complication of old age. While genetics may play a role, the greatest risk factor for the development of disease in children is obesity.

Over the past 30 years, the Centers for Disease Control reports the incidence of obesity has doubled in children and tripled in adolescents.

The Louisiana Council on Obesity Prevention and Management data indicate the prevalence of obesity among Louisianans has increased by 135 percent since 1990. Now, the LA Obesity Council reports an estimated 47.5 percent of the state’s children ages 2 to 19 are overweight or obese.

As the occurrence of obesity skyrockets in children, so does the expense. In the past 20 years, the LA Obesity Council estimates the cost of obesity-related illnesses in Louisiana children rose from $35 million to $127 million.

Since this health issue threatens so many children in Louisiana and throughout the nation, PBRC has put its formidable resources toward finding ways to improve their long-term health and survival.

While obesity can interfere with the body’s ability to regulate blood sugar in both segments of the population, “Type 2 diabetes in children is a different disease than in adults,” said PBRC’s Dr. Daniel Hsia, assistant professor of research. “In adults, you could have diabetes for 15 years (without) symptoms and not even know about it. But (in children) it appears more aggressive and poses a greater risk for complications at an earlier age.”

The E-logic study is now enrolling children ages 10 to 17, who have been diagnosed with Type 2 diabetes, have a body mass index of more than 50 and weigh 110 pounds. In addition to the pre-requisite testing, the clinical trial involves three outpatient visits for participants to receive medication and monitoring.

Besides contributing to medical research and a $300 stipend, study participants and their parents benefit from evaluation, individualized attention and counseling from medical experts who specialize in diabetes treatment and research.

During clinic visits, each child will receive either a low or high dose of the drug Lixisenatide or a placebo. Neither the participant nor the staff will know which the patient gets.

Currently, Metformin is the only medication approved to treat the disease in children age 10 and older. The prescription helps control the amount of sugar in the bloodstream, decreases the amount of sugar absorbed from food and increases the body’s response to insulin.

“Metformin is not sufficient for everybody,” explained Hsia. “It probably is only effective for a short period of time. It is all we have — besides insulin — to treat the disease in children.”

The international E-Logic study intends to determine whether Lixisenatide can halt or slow the progression of pre-diabetic syndrome into insulin-dependent diabetes in pre-teens and adolescents.

If the trial demonstrates its effectiveness, Hsia said, “This would be a new drug and will add to what we can provide already.”

For more information, visit pbrc.edu, email clinicaltrials@pbrc.edu or call (225) 763-3000.