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University of Iowa News Release

Oct. 12, 2004

photos: William Clarke, left; Lawrence Hunsicker, right

UI Center Receives $21 million To Coordinate Data In Diabetes Study

University of Iowa researchers in the College of Public Health and Roy J. and Lucille A. Carver College of Medicine have received a $21 million, five-year grant from the National Institutes of Health to operate the data coordinating center for an international research consortium studying islet transplantation in patients with type 1 diabetes. The network of five clinical centers will focus on improving the safety and long-term success of methods for transplanting islets, the insulin-producing cells of the pancreas.

The Clinical Trials Statistical and Data Management Center (CTSDMC) in the UI Department of Biostatistics was awarded the grant to establish the data coordinating center and facilitate multiple aspects of the research activities. 

"The data coordinating center will work with the investigators to develop and implement important clinical and laboratory studies," said William Clarke, Ph.D., principal investigator of the Iowa portion of the study, UI professor of biostatistics and director of the CTSDMC. "Multi-center trials generate massive amounts of data that must be gathered, managed and analyzed statistically. The data coordinating center will consolidate data from the five clinical centers as well as assist in study design and provide organizational support." 

Islet transplantation is a promising experimental approach to treating type 1 diabetes, which accounts for up to 10 percent of diagnosed cases of diabetes in the United States (up to 1 million people). This form of diabetes usually strikes children and young adults, who need several insulin injections a day or an insulin pump to survive. Insulin shots, though critical now for controlling blood glucose, do not restore normal physiological control of blood sugar. Therefore, many people with type 1 diabetes eventually develop one or more complications, including damage to the heart and blood vessels, eyes, nerves and kidneys.

"Replacement of islet function through transplantation, with restoration of normal glucose control, is the best hope to avoid the complications of diabetes in these patients," said Lawrence Hunsicker, M.D., UI professor of internal medicine and co-principal investigator of the study.

In islet transplantation, islets are first extracted from the pancreas of a deceased donor and infused into a person with type 1 diabetes through the portal vein of the liver. In successful transplants, the cells lodge in the liver's small blood vessels and begin producing insulin. Only a very small number of such transplants have been done at this time in people with difficult-to-control type I diabetes.

There are several impediments to the wider testing of islet transplantation. One is the scarcity of islets - pancreases from only about 6,000 donors become available each year in the United States, and many are used for whole organ transplantation. One of the objectives of this consortium is to study ways in which islets can be expanded in vitro to make human islets available to many more patients. Another obstacle to islet transplantation is the side effects of the medications that are needed to prevent the immune system from rejecting donor islets. The consortium will be studying immunosuppressive strategies that are both more effective and safer for the recipients of islet transplants.

Other UI researchers involved in the study are co-principal investigator Kathryn Chaloner, Ph.D., professor and head of biostatistics; Joseph Dillon, M.D., and Robert Spanheimer, M.D., associate professors of internal medicine; Julie Lang, study coordinator; Richard Peters, database administrator; and Michelle Wichman, CTSDMC coordinator.

In addition to the UI data coordinating center, the research consortium consists of clinical centers in Miami; Minneapolis; Philadelphia; Edmonton, Canada; and Uppsala, Sweden. 

MEDIA CONTACT: Debra Venzke, 319-335-9647, Writer: Kate Gleeson