Preventing or delaying the onset of diabetes could prevent or delay blindness, heart disease, nerve and kidney disease.
Researchers at the University of Nebraska Medical Center are participating in the Type 1 Diabetes TrialNet, a multi-center, international research study, with hopes of accomplishing just that. The study aims to prevent or delay the onset of type 1 diabetes, or insulin-dependent diabetes in children and young adults.
Several institutes of the National Institutes of Health granted funds to multi-clinical centers to build a consortium of researchers to develop and conduct diabetes prevention trials.
TrialNet is a network of 18 clinical centers working in cooperation with screening sites throughout the United States, Canada, Finland, United Kingdom, Italy, Germany, Australia, and New Zealand. The network is an outgrowth of the former Diabetes Prevention Trial-Type 1 international study in which UNMC previously participated.
James Lane, M.D., associate professor, UNMC Section of Diabetes, Endocrinology and Metabolism, is leading a 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 in order to increase understanding of factors involved in development of the disease.
UNMC will work with the University of Minnesota which is one of the 18 centers. George Washington University is coordinator of the multi-center study. UNMC will receive stipends based on number of study participants recruited.
“The idea of TrialNet is to have centers work on this problem together,” Dr. Lane said. “If a study becomes available under the 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.
“We have a handle on who will most likely get Type 2 diabetes, but not Type 1. It is much more difficult to predict who will get Type 1,” he said.
Dr. Lane and his colleagues, say Nebraska is currently experiencing a small epidemic of new onset of cases of Type 1 compared to past years, especially in children. Some of the increase has to do with obesity, and possibly environmental factors that affect how the immune system responds.
Type 1 diabetes is a disease that results from the destruction of cells in the pancreas. It can occur at any age, but its incidence is highest in children and adolescents. Although all people are susceptible, relatives of individuals with Type 1 are at much greater risk for development of the disease.
Despite many improvements in the last two decades, current therapy for type 1 diabetes remains unsatisfactory, Dr. Lane said.
UNMC hopes to recruit 400 study participants with a family history of type 1 diabetes, age 1 to 45, who have a parent, brother or sister, or grandparent or cousin with type 1 diabetes. The study is one of several different protocols administered by George Washington University.
Tests, materials and health care related to the research study are provided free. Dr. Lane said individuals who participate in the study will be informed whether they are at low, moderate or high risk for developing type 1 diabetes.
In the first phase of the UNMC study, participants will be screened. If found to have positive antibodies, they 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 who are diagnosed with type 1 diabetes may be eligible to participate in national studies.
“If at high risk, then they might consider participating in clinical trials that might decrease their risk of develop diabetes. This study would monitor them in a medical environment and ideally enable them to benefit from newly developed treatments,” Dr. Lane said.
UNMC previously participated in a TrialNet study that tested 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 could 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, only add to it and make it better.”
In Nebraska, it is estimated about 84,000 adults age 18 and over, have some kind of diabetes, with 10 percent, or 8,400 with type I, according to the Nebraska Department of Health and Human Services System. Type 1 diabetes usually is diagnosed in those age 30, of average or lower weight who sometimes have a blood relative with the disease. Nationally about 21 million adults have diabetes, with about 2 million with type 1.
Dr. Lane said even when patients develop Type 1 diabetes, some can still can maintain ability to secrete insulin. “It may be that some type of intervention that stunts the immune system may help in some way to 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.”
One of the tools researchers will test in study participants who qualify is an immunosuppressant medication to evaluate if it protects insulin-producing cells. “It’s thought that roughly 20 to 30 percent of insulin-producing cells are still viable and if you can do something to protect those remaining cells to delay onset or preserve cells,” he said.
He said those with type 1 diabetes begin 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 if we get early treatment and improved treatment, that patients could be protected from these complications. Not only is that an issue to maintain health for a long period of time but if you have to see what people go through that are treated with diabetes with frequent monitoring of the their blood sugars, frequent injections or treatment with insulin pumps, you’ll understand there’s a lot of rigorous time and effort put in by the patients, their families and the medical care that treats them,” 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.