Preventing or delaying the onset of diabetes could avert or postpone blindness, heart disease, nerve and kidney disease. UNMC researchers are participating in a multi-center, international research study with hopes of accomplishing just that.
The goal of the study, known as Type 1 Diabetes TrialNet, is to prevent or delay the onset of Type 1 diabetes, or insulin-dependent diabetes, in children and young adults.
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James Lane, M.D. |
TrialNet is a network of 18 clinical centers working with screening sites throughout the United States, Canada, Finland, United Kingdom, Italy, Germany, Australia and New Zealand. UNMC will work with the University of Minnesota, which is one of the 18 centers.
James Lane, M.D., associate professor, UNMC Section of Diabetes, Endocrinology and Metabolism, is leading the five-year UNMC study called “Natural History Study of the Development of Type 1 Diabetes,” one of several protocols under TrialNet. The study will promote earlier identification of the disease, as well as find new and better ways to prevent or delay the onset of diabetes.
Researchers will collect information to characterize an individual’s risk for developing Type 1 diabetes and study how the disease evolves to increase understanding of factors involved in the development of the disease.
“The idea of TrialNet is to have centers work on this problem together,” Dr. Lane said. “If a study becomes available under TrialNet, treatment and prevention interventions for Type 1 diabetes will be available to people in Omaha and surrounding areas. These are the same studies that would be available to individuals all over the world. The more studies and people involved, the more knowledge we gain about preventing the onset of this disease.
Physicians know who is most likely to get Type 2 diabetes, but “it is much more difficult to predict who will get Type 1,” Dr. Lane said.
Nebraska is seeing growing numbers of new Type 1 cases compared to past years, Dr. Lane said, especially in children. The increase relates to obesity and possibly environmental factors that affect how the immune system responds, he said.
Type 1 diabetes results from the destruction of cells in the pancreas. It can occur at any age, but its incidence is highest in children and adolescents. All people are susceptible, but relatives of individuals with Type 1 are at much greater risk for developing the disease.
Current therapy for Type 1 diabetes remains unsatisfactory, Dr. Lane said, despite improvements in the past two years.
UNMC hopes to recruit 400 study participants – ages 1 to 45 — who have a parent, brother, sister, grandparent or cousin with Type 1 diabetes.
Individuals who participate in the study will learn whether they are at low, moderate or high risk for developing Type 1 diabetes, Dr. Lane said. Tests, materials and health care related to the research study are provided free.
Participants will be screened during the first phase of the UNMC study. Individuals with positive antibodies will receive a formal evaluation of their risk for developing diabetes. If they fall into moderate or high risk, they will receive periodic evaluations. Those diagnosed with Type 1 diabetes may be eligible to participate in national studies.
“If they are at high risk they might consider participating in clinical trials that might decrease their risk of developing diabetes,” Dr. Lane said. “This study would monitor them in a medical environment and, ideally, enable them to benefit from newly developed treatments.”
UNMC previously participated in a TrialNet study testing the notion that administering low doses of insulin to those at moderate or high risk for Type 1 diabetes might prevent or delay the onset of the disease.
“Though low doses of insulin didn’t prevent or delay the onset of Type 1 diabetes, we were able to successfully show that you could predict, with some accuracy from those we screened, who would ultimately develop Type 1 diabetes,” Dr. Lane said. “We want to use a similar screening strategy with this study.”
In Nebraska, an estimated 84,000 adults age 18 and over have diabetes. Of those, approximately 8,400 – or 10 percent — have Type I diabetes, reports the Nebraska Department of Health and Human Services System. Type 1 diabetes usually is diagnosed in 30-year-olds of average or lower weight who may have a blood relative with the disease. Nationally about 21 million adults have diabetes. Of those, 2 million have Type 1.
In the study, UNMC researchers will evaluate an immunosuppressant medication to determine whether it protects insulin-producing cells. Patients with Type 1 diabetes may still have the ability to secrete insulin, Dr. Lane said. “Some type of intervention that stunts the immune system may help prevent the absolute destruction of the insulin producing cells and allow them to have some ability to maintain insulin, making it easier to treat them,” he said.
Researchers are trying to figure out new ways of preventing and delaying the onset of Type 1 diabetes. “Diabetes is a disease that’s increasing in epidemic proportions all over the world,” Dr. Lane said. “Diabetes associated closely with Type 2 diabetes and obesity makes up 90 percent of all with diabetes.
“With Type 1 diabetes, patients have to be treated with insulin at a very young age,” Dr. Lane said. “Once you’ve had destruction of the beta cells, there isn’t a good way of bringing them back, so preserving what you have left is a key strategy.”
Individuals with Type 1 diabetes start using insulin at the time of diagnosis. Complications of the disease, which result from elevated blood sugars over a long period, include blindness, heart disease, and nerve and kidney disease.
“The whole goal is to protect patients from these complications through early and improved treatment,” Dr. Lane said.
TrialNet also is supported by the National Center for Research Resources, the Juvenile Diabetes Research Foundation International and the American Diabetes Association.