Family relatives with higher risk, looking for auto-antibodies.
The object of the study is to test oral insulin. We hope that it will calm the auto immune attack. Oral insulin has no affect on blood sugar; taking it orally does nothing for the disease: it is a protein that the body digests.
But when ingested, oral insulin seems to alters the immune attack.
This is a huge study: over 100 institutions will be conducting the study. Hope to screen 20,000 family members a year, look to screen 200,000 family members.
It is expected that 3-4 percent of family members to have the autoimmune attack (develop Type I diabetes). It can develop up to age 45 years, and what was once thought to occur in childhood can occur as an adult.
The screening is a simple blood test with blood drawn from the individual. For younger children, a topical anesthetic is used to lessen the pinch. Results are available four to six weeks
Scientists have learned that two types of immune cells, B cells and T cells, are involved in causing type 1 diabetes. T cells are responsible for attacking and destroying the beta cells that make insulin.
Although they don't attack insulin producing cells, B cells may be what trigger the T cells to attack.
With fewer insulin producing cells your blood glucose increases, causing hunger, thirst, and unexplained weight loss. By the time you have these symptoms, many (but not all) insulin producing cells have already been destroyed. It is hoped rituximab can help lower the number of immune B cells in patients recently diagnosed with type 1 diabetes and prevent destruction of the remaining insulin producing beta cells. If this approach works, your diabetes will be easier to manage and cause you fewer problems later on.
Medicines that slow down the immune system have been used to treat other diseases. Rituximab is such a medicine. Its effects on the immune system are well understood.
It is approved by the FDA for the treatment of a condition called B-lymphocyte lymphoma. Research has shown that it might be helpful in treating other conditions caused by T cells and B cells, including type 1 diabetes.