Study Tests Powdered Insulin to Prevent Diabetes
Defusing the Assult continued...
“We know that once the process has started, it’s pretty hard to turn it off,” Bonifacio says.
In the new study, “we’re giving the oral insulin at this very early stage when the immune system is learning,” he says. And his team found evidence that the immune system was turning itself down in response to the challenge.
The researchers enrolled 25 children who were at high risk of getting type 1, because they had both a strong family history and genes linked to the disease. But their bodies had not yet begun the immune attack that leads to diabetes.
Fifteen of the kids, who ranged in age from 2 to 7, ate a daily dose of powdered insulin sprinkled on food. The other 10 ate food sprinkled with a placebo. The insulin doses ranged from 2.5 milligrams to 67.5 milligrams, and the kids took it for a time period ranging from 3 to 18 months.
People who inject insulin to control their blood sugar might take a dose in the range of 10 “units,” Bonifacio says. The children in the study on the highest insulin dose were swallowing a daily equivalent of about 3,000 units.
Despite the high dose, none of the children in the study got dangerously low blood sugar, which was one fear at the start.
“Less than 1% of the insulin is absorbed into the bloodstream,” Bonifacio says.
Five of six kids who were on the highest dose had an immune response to the insulin. Those responses seemed to suggest that the immune system was learning to tolerate the protein, not to attack.
More Research Needed
This is the first time that scientists have been able to demonstrate that a treatment given before someone gets type 1 diabetes can impact the immune system in a way that might protect against the disease, says Julia Greenstein, PhD, vice president of Discovery Research at the Juvenile Diabetes Research Foundation, one of the organizations that funded the study.
Despite the intriguing result, researchers say more work is needed before they’ll know if this approach can head off the disease.
Researchers are planning a new trial to study the highest dose of insulin. That will start later this year. They expect to have results by 2017. A prevention trial, which will attempt to show that the treatment can stop or delay the development of type 1 diabetes, will take 8 or 9 years, Bonifacio says.
The study is published in the Journal of the American Medical Association.