Release Date: July 5, 2006
BUFFALO, N.Y. -- Researchers at the University at Buffalo are beginning two new studies as part of an international effort to prevent type 1 diabetes.
The project, called Type 1 Diabetes TrialNet, involves researchers at 22 clinical centers in the U.S. and in centers in Canada, Europe, Australia and New Zealand. The investigators will identify 100,000 persons at risk of developing type 1 diabetes and test interventions to prevent the onset of the disease.
Teresa Quattrin, M.D., UB associate professor of pediatrics and chief of the Division of Endocrinology-Diabetes at The Women and Children's Hospital of Buffalo, where the Buffalo TrialNet clinical center will be located, is principal investigator in Buffalo.
The research is funded by a $172,364 grant from the National Institutes of Health.
Type 1 diabetes is an autoimmune disease in which the body's immune system attacks the beta cells in the pancreas that produce insulin (in contrast to type 2 diabetes, in which cells stop absorbing the insulin the body produces). Insulin is necessary to metabolize glucose and supply the body with energy.
Damage to the beta cells occurs over a period of years. When about 90 percent of the cells have lost the ability to produce insulin, the disease manifests itself, primarily in childhood, adolescence and young adulthood.
"The many years of this destructive process preceding the onset of type 1 diabetes represent a tremendous window of opportunity to prevent the disease," Quattrin said. "Via TrialNet, we can identify persons who are on the path to developing type 1 diabetes with simple blood tests."
In the initial phase of this project, called the Natural History Study, Quattrin and her team will screen people at increased risk for developing type 1 diabetes. Persons considered at risk and eligible to be screened fall into two groups: those 45 or younger who have a brother, sister, child or parent with type 1 diabetes; or those 20 or younger who and have a cousin, aunt, uncle, niece, nephew, half-sibling or grandparent with type 1 diabetes.
"The risk of any given child developing type 1 diabetes is 1 in 400," said Quattrin. "However, if there already is a relative affected by type 1 diabetes in the family, that risk increases significantly. For example, if a child has a sibling with type 1 diabetes, his or her own risk of developing type 1 diabetes increases to 1 in 100."
The first screening test will look for auto-antibodies associated with type 1 diabetes in the blood, an indication that the body's immune system may be attacking the insulin- producing cells in the pancreas, increasing the risk for developing diabetes.
Participants will be categorized into one of three risk groups, depending on the concentration of autoantibodies. This risk-assessment method is called "staging" and is considered to be very accurate.
Different preventative strategies are being planned depending on results of the staging.
"Those determined to have less than 50 percent risk of developing type 1 diabetes within five years may be eligible to receive oral insulin in an attempt to halt the beta cell destruction process," Quattrin said. "Other trials for participants whose risk is considered greater than 50 percent are being proposed for FDA approval. All participants will be followed yearly or more often, depending on their risk group, to see if their immune function improves, remains unchanged or deteriorates."
The second study phase will involve collecting blood samples from families who have two affected siblings with type 1 diabetes (TRIG study) to study the genetic makeup of these families. "This is a very important and promising study," said Quattrin. "Learning what is causing certain families to have more than one affected child will provide information that is key to preventing the disease in the general population." Samples will be collected from affected children and up to two non-affected siblings and parents.
Quattrin and her team also are conducting a study in children and adolescents newly diagnosed with type 1 diabetes using an immune modulator called Enbrel, a drug that has been used to treat other autoimmune diseases such as rheumatoid arthritis. While this study is not part of TrialNet, Quattrin said she anticipates that the diabetes center at Women and Children's Hospital will be involved in similar studies as part of the TrialNet mission.
"The goal of this study is to slow the progression and/or halt the beta cell destruction in patients who already are diagnosed," said Quattrin. "After diagnosis, there is a period called partial remission, or a 'honeymoon period,' where the patient's pancreas recuperates the ability to make a significant amount of insulin. This study intervenes in this phase."
Individiuals interested in participating in any of these studies may contact Angela Clark, the project coordinator, at 716-878-7268 or email firstname.lastname@example.org.
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