Preventive insulin therapy could help at-risk kids
Preventive insulin therapy could help at-risk kids
Daily injection may tip autoimmune balance
For the past five years, 21-year-old Neil Gilbert of Acton, MA, has injected himself with a tiny dose of insulin each day. Gilbert doesn’t have diabetes. He and his doctors are hoping the daily regimen will keep him from ever getting it, since he has the antibodies that could make him predisposed to diabetes.
The young man is one of hundreds of at-risk individuals participating in the Diabetes Preven-tion Trial, Part 1 (DPT-1) aimed at discovering ways to keep young people like Gilbert from getting the disease, or at least delaying its onset.
Researchers are working under the guidance of Jay Skyler, MD, chairman of the DPT-1 study and professor of medicine and pediatrics at the University of Miami. They have sifted through tens of thousands of medical records looking for the right subjects — family members of patients with Type 1 diabetes who test positive for the antibodies that destroy insulin-producing pancreatic cells.
Skyler’s team is still recruiting at nine centers nationwide in hopes of finding as many as 300 more patients to add to the 500 already enrolled. (See list of centers, above.)
Close relatives of Type 1 patients are 10 to 20 times more likely to develop the disease than the general population, but 96.5% of those who are tested do not have the antibodies, so recruiting study participants is a process of searching for "needles in haystacks," says Skyler.
They’ve tested more than 80,000 relatives of people with Type 1 diabetes thus far. Initially, researchers restricted the testing to first-degree relatives, but they have recently expanded the study to cover second-degree relatives as well in hopes of obtaining a sample of adequate size.
Those who do have the antibodies are tested for pancreatic function and given gene tests to determine if they have a gene that seems to protect against the disease.
Those who are assessed at high risk (50% or more likelihood of developing the disease within five years) are randomized, half to a control group and half to a group given a single dose of insulin a day. They are asked to monitor blood glucose sporadically. Skyler and his team are hoping that a single small dose of insulin each day might spare young people like Gilbert the pain and inconvenience of multiple daily insulin injections and fingersticks, not to mention the complications that almost inevitably develop from the disease.
Participants also are admitted to a DPT-1 center once a year for four days of insulin therapy.
A lower-risk group assessed at a 25% to 50% likelihood of developing diabetes within five years is being randomized to daily doses of oral insulin.
Type 1 diabetes is caused by an autoimmune response to the body’s own insulin-production system. "We are hoping that the insulin in small doses will tip the autoimmune balance in favor of these patients and keep them from getting the disease," says Skyler. Aside from a few sporadic incidents of shakiness, there have been no hypoglycemic incidents among study participants because the dosage is so low, he says.
Looking at close relatives of Type 1 patients is a good research tool. But it will certainly not catch those most at risk: the 90% who will be diagnosed with Type 1 diabetes who have no relatives with the disease, notes Richard Furlanetto, MD, PhD, science director of the Juvenile Diabetes Founda-tion International in New York City, a sponsor of the DPT-1.
However, relatives are a good starting point because their risk is 10 times that of the general population, he adds. "What we’re trying to do here is almost like the process of desensitizing someone to an allergen by giving them small amounts of the irritant and building up their immunity over a period of time."
Results are not yet available, because the study population has not been closed, but Furlanetto says this part of the DPT-1 is a "good starting point, even though it is a shot in the dark."
"It’s worth it if we an do something like this safely that might prevent the onset of diabetes," he says, although there are still several questions to be answered. "The general feeling is that this may help, but it’s not the answer to the big question of how to prevent the onset of diabetes."
In mid-January, Skyler convened an international meeting in Miami, gathering 126 experts in the field. Some of the information collected may be published in the near future. The progress of the preventive insulin therapy study was on the agenda as well as a number of other topics related to DPT-1’s mission to find out if Type 1 diabetes can be prevented.
[For more details, contact Jay Skyler at (305) 243-6018 and Richard Furlanetto at (800) JDF CURE.]
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