Study tests oral insulin to prevent type 1 diabetes

autoantibodies to glutamate decarboxylase (GAD), IA-2, and to insulin itself indicate a greater risk for developing type 1 diabetes. For a person with high-risk genes and all three antibodies, the risk of developing diabetes in the next 5 years is greater than 50 percent.

First- and second-degree relatives of people with type 1 diabetes who may be at risk are being screened through TrialNets natural history study, which is examining the immune and metabolic events that precede diabetes symptoms. Screening involves a simple blood test for the autoantibodies that signify diabetes risk. Individuals enrolled in the natural history study are closely monitored for diabetes development and may be eligible to participate in the oral insulin trial or future studies that try to arrest the autoimmune process.

Studies for the Newly Diagnosed

TrialNet studies are also aimed at safely preserving insulin production in people recently diagnosed with type 1 diabetes. In the few months after diagnosis, most patients still have a supply of functioning beta cells that, with the help of insulin injections, contribute to good control of blood glucose. If beta cells can be protected, more patients would be able to tightly control their blood glucose, which prevents or delays damage to the eyes, nerves, kidneys, heart, and blood vessels.

One TrialNet study seeks to turn off the immune attack on beta cells with Rituximab, a monoclonal antibody that binds to and temporarily destroys a specific class of immune cells. The Rituximab trial is recruiting patients with type 1 diabetes diagnosed within the previous 3 months. Rituximab is approved by the Food and Drug Administration (FDA) to treat specific forms of lymphoma and moderate to severe rheumatoid arthritis. It is not approved for the prevention of type 1 diabetes.

Also under way is a study testing whether mycophenolate mofetil (MMF) or MMF plus daclizumab (DZB), drugs appro

Contact: Joan Chamberlain
NIH/National Institute of Diabetes and Digestive and Kidney Diseases

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