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Studies Aim to Protect Insulin-Producing Cells in Type 1 Diabetes


             The Diabetes Research Institute at the University of Miami Leonard M. Miller School of Medicine has been chosen as one of 18 medical centers around the world to begin new clinical studies in type 1 diabetes. The announcement came today at the annual scientific meeting of the American Diabetes Association.  The studies, funded by the National Institutes of Health, are trying to find a way to slow or stop the immune system’s attack on insulin-producing beta cells in people newly diagnosed with type 1 diabetes, and in those at risk for developing it.
             “The more beta cells a person has, the easier it is to control diabetes and prevent complications,” said Jay Skyler, M.D., professor of medicine at the Miller School of Medicine and chairman of Type 1 Diabetes TrialNet, an international network of researchers and labs dedicated to the study, prevention and early treatment of type 1 diabetes.  “With these studies, we hope to stop the immune system’s attack on these cells and keep the disease from getting worse.”
             In type 1 diabetes, a person’s own immune system destroys the beta cells of the pancreas.  Beta cells sense glucose in the blood and produce the hormone insulin, which regulates glucose and converts it to energy.  Type 1 accounts for 5 to 10 percent of diagnosed diabetes cases in the United States—up to a million people.  People with type 1 diabetes usually need three or more insulin injections a day or treatment with an insulin pump, as well as careful monitoring of blood glucose and attention to diet and exercise, to properly control their blood glucose. 
            University of Miami researchers are enrolling patients in a study that hopes to safely preserve insulin production in people newly diagnosed with type 1 diabetes. Patients will be randomly assigned to receive the experimental treatment or placebo and will be closely monitored for any possible side effects of the drugs. 
Earlier research has shed light on how a subgroup of T cells, the “warrior” cells of the immune system, seek out and attack insulin-producing cells.  Another group of immune cells, called B cells, are thought to raise the alarm by presenting antigens to T cells, urging them to take action. 
             This insight is being tested in a study that seeks to silence the alert by reducing the number of circulating B cells.  In the study, researchers are testing the use of Rituximab, a monoclonal antibody that binds to a receptor on the surface of B cells and destroys them.  Rituximab, approved by the Food and Drug Administration to treat B cell non-Hodgkin’s lymphomas, has been used with few adverse effects to treat other autoimmune diseases, such as chronic idiopathic thrombocytopenia, myasthenia gravis, and rheumatoid arthritis.
             “This is a very exciting opportunity to see if it is possible to preserve insulin secretion early on in the disease process, which may have important long term benefits for individuals who need to manage the disease over a lifetime,” said Jennifer Marks, M.D., professor of medicine, and principal investigator of the Rituximab trial at the University of Miami Miller School of Medicine.
                University of Miami researchers are also continuing the natural history study.  This study probes the causes of type 1 diabetes by examining the immune and metabolic events that precede diabetes symptoms.  The researchers are screening two groups of relatives of those with type 1 diabetes:  first-degree relatives ages 1 to 45 and second-degree relatives ages 1 to 20.  Screening involves a simple blood test for the autoantibodies that appear in at-risk people years before diabetes develops. 
               After enrolling in the study, participants will be closely monitored for diabetes development and may be eligible to participate in studies that try to arrest the disease. 
            The Type 1 Diabetes TrialNet is supported by the National Institutes of Health, part of the Department of Health and Human Services, as well as the Juvenile Diabetes Research Foundation International, and the American Diabetes Association.
Media Contact: Jeanne Antol Krull
June 12, 2006