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A treatment affecting the immune system has actually slowed the progression of type 1 diabetes in high-risk people, according to findings from research funded by the National Institutes of Health. This study is the first to show that clinical-type diabetes can be delayed for two years or more in high-risk individuals. These findings were published online in the New England Journal of Medicine and presented at the scientific sessions of the American Diabetes Association in San Francisco.
The study, which involved treatment with a monoclonal anti-CD3 antibody (teplizumab), was performed by Type 1 Diabetes Trial,
international collaboration to find ways to delay or
Prevent type 1 diabetes. The researchers enrolled 76 participants aged 8 to 49 years.
who were parents of people with type 1 diabetes, had at least two
types of autoantibodies related to diabetes (proteins made by the immune system
system) and abnormal tolerance to glucose (sugar).
Participants were randomly badigned to the treatment group,
who received 14 days of teplizumab, or the control group,
who received a placebo. All participants received glucose tolerance
regularly tests until the end of the study or until its development
Clinical Type 1 Diabetes – whichever comes first.
During the test, 72% of the control group developed
clinical diabetes, compared to only 43% of the teplizumab group. the
median time for control group members to develop clinical diabetes
24 months, while those who developed clinical diabetes
the treatment group had a median time of 48 months before progressing
to the diagnosis.
"The difference in results was striking. This discovery is the
first evidence that we have seen that clinical type 1 diabetes can be delayed
early preventive treatment, "said Lisa Spain, Ph.D., Project
Scientist at the National Institute of Diabetes and Digestion of NIH
and Kidney Disease (NIDDK), sponsor of TrialNet. "The results have
important implications for people, especially young people, who have
relatives with the disease, who may be at high risk and
benefit from early screening and treatment. "
Type 1 diabetes develops when immune system T cells are mistaken
destroy the body's own insulin-producing beta cells. Insulin is needed
convert glucose into energy. Teplizumab targets T cells to decrease the
destruction of beta cells.
"Previous clinical research funded by the NIH has shown that teplizumab
effectively slows down beta cell loss in people with recent onset
clinical type 1 diabetes, but the drug has never been tested on people
who had no clinical illness, "said Kevan C. Herold, MD, of Yale
University, lead author of the study. "We wanted to see so soon
intervention would have an advantage for people who are at high risk but not
no symptoms of type 1 diabetes yet. "
The effects of the drug were greatest in the first year after administration.
given when 41% of participants developed clinical diabetes, mainly in
the placebo group. Many factors, including age, could have contributed
teplizumab to delay clinical disease because patients at risk
children and adolescents are known to progress faster to type 1 diabetes
than adults. A faster progression of type 1 diabetes is badociated with a
very active immune system, which may explain the impact of immune systems
drugs modulating the system like teplizumab.
Other data collected during the test may help researchers to
understand why some people responded to treatment. Participants who
Teplizumab tends to have some autoantibodies and others
characteristics of the immune system. The research team also warned that the
the study had its limitations, especially the small number of participants,
their lack of ethnic diversity and that all participants were parents
people with type 1 diabetes, potentially limiting the ability of
translate the study in a broad sense.
"While the results are encouraging, more research is needed
to meet the limits of the trial, as well as to understand the
mechanisms of action, long-term efficacy and safe treatment ",
said Dr. Spain.
"This essay illustrates how decades of research on the biology of
Type 1 diabetes can lead to promising treatments that have a real impact
about people's lives. We are very happy to see the next steps of this
research, "said Griffin P. Rodgers, director of NIDDK.
researchers, volunteers and families participating in this program
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