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Clinical Research

Family Studies
It is now understood that childhood diabetes is an autoimmune illness, and thus more similar to rheumatoid arthritis or multiple sclerosis than other forms of diabetes. The foresight of the founders of the Barbara Davis Center from the beginning led to the Center's focus on the autoimmunity of diabetes. Studies by the immunologists in the BDC Research Division, combined with our Clinical Division's, those of Dr. George S. Eisenbarth, MD. Ph.D., executive director, and our national and international collaborators and colleagues, have led to the first clinical trials for the treatment of diabetes as an autoimmune illness.
Environmental Causes of Type 1 Diabetes
A large team of investigators under the direction of Dr. Marian Rewers is searching for environmental triggers of childhood diabetes in DAISY and TEDDY studies.
The Diabetes Auto Immunity Study in the Young (DAISY) started in July 1993 and screened over 31,000 newborns for genetic markers of type 1 diabetes risk. The study is funded by the National Institutes of Health (NIH). Over 2,500 high-risk infants have been followed up to learn how genes and the environment interact to trigger the onset of type 1 diabetes. In order to do this, the study follows two unique groups, children with a diabetic relative (either a sibling or parent), and children at an increased genetic risk (without a diabetic relative). While the study is ongoing, investigators have already been able to find some of the most important genes and environmental triggers which may increase the chances of developing the disease.
The Environmental Determinants of Diabetes in the Young (TEDDY) consortium, funded by the NIH in 2002, is an international extension of the work initiated by DAISY. Six groups of research doctors from across the world are working together in this study to screen over 350,000 newborns and follow nearly 8,000 of those with higher risk genes. All of the centers are collecting the same information about the viruses, dietary factors, immunizations, and stressors in the lives of children in the study to determine the factors that could be changed to prevent diabetes. TEDDY centers are located in Denver (headed by Dr. Marian Rewers), Seattle, Florida, Georgia, Sweden, Finland, and Germany.
BCG Vaccine
Drs. Klingensmith, Allen, Hayward and Chase began a trial in September of 1993 giving either BCG vaccine or a placebo to 100 newly diagnosed children with diabetes. This was a tuberculosis immunization given to see if it would alter the immune system to help save the remaining insulin-producing cells in newly diagnosed children. The enrollment phase of this study is completed. This study is still in progress and the benefit of BCG is still unknown.
Transplant Studies
The immunologic "vaccines" we want are not just to prevent diabetes, but to prevent autoimmunity from destroying transplanted islets. The same process which causes diabetes targets the islets which should be able to cure diabetes. Drs. Ronald Gill and Mark Stegall, along with patient volunteers who have a kidney transplant because of diabetic kidney disease, have initiated studies of human islets transplanted in the forearm to identify and clone the human T cells causing diabetes.
Genetics
Many laboratories and researchers including the Barbara Davis Center are now actively involved in family studies of diabetes with hopes of mapping and cloning other genes that influence the risk for diabetes and/or complications resulting from diabetes. The results to date indicate that the insulin gene on human chromosome 11 or a gene nearby may increase the risk for diabetes, especially in offspring of affected fathers. About 10 other genes have also been implicated; however, the significance of these results remains unclear. Although the genetics of diabetes is a relatively new area of research at the Barbara Davis Center, researchers at the Center are internationally recognized experts on the autoimmune response and its relationship to diabetes. Studies are now underway or in the planning stages to combine this experience with Human Genome Project technology and resources with the expectation that the Center will gain similar recognition as leaders in research into genetic causes of autoimmunity and diabetes.
Type 1 Diabetes Trialnet
The Natural History Study of the Development of Type 1 Diabetes will study people at increased risk for type 1 diabetes to learn more about how type 1 diabetes occurs.

Click here to visit the BDC Trialnet web page and read more about how to participate in these studies.

Understanding Diabetes - new! 11th Edition
by Dr. H. Peter Chase, MD

Type 1 Diabetes: Cellular, Molecular & Clinical Immunology
edited by George S. Eisenbarth & Kevin Lafferty
Updated chapters and teaching slides online

Please click here for a list of Clinical Division members.

Please click here for a list of Research Division members.