TrialNet Launches First Studies in Type 1 Diabetes Focus on preserving beta cells, understanding disease beginnings
Type 1 Diabetes TrialNet, a newly formed network of 18 clinical
centers in the United States, Canada, Europe, and Australia, has
launched its first two clinical studies, HHS Secretary Tommy G.
Thompson announced today. One study examines the biological basis
of type 1 diabetes in at-risk people. The other seeks to preserve
insulin-secreting beta cells in patients newly diagnosed with type
1 diabetes. Additional studies will become available as researchers
develop protocols to test promising preventions and treatments.
"These new studies will help researchers learn more about
preventing and treating type 1 diabetes, which is usually diagnosed
in children and young adults but can occur at any age," said
Secretary Thompson.
Type 1 diabetes, formerly known as juvenile onset diabetes, develops
when the body's immune system mistakenly destroys the insulin-producing
beta cells of the pancreas. The hormone insulin is needed to convert
glucose into energy. People with this form of diabetes need several
insulin injections a day or an insulin pump to survive. However,
insulin replacement is not a cure, and most people with type 1 diabetes
eventually develop one or more complications of diabetes, including
damage to the eyes, nerves, kidneys, and blood vessels. Type 1 diabetes
accounts for 5 to 10 percent of all diagnosed cases of diabetes.
About 18.2 million people 6.3 percent of the U.S. population have
diabetes. It is the main cause of kidney failure, limb amputations,
and new onset blindness in adults and is a major cause of heart
disease and stroke. Type 2 diabetes, which accounts for up to 95
percent of all diabetes cases, is associated with older age, obesity,
family history of diabetes, history of gestational diabetes, impaired
glucose metabolism, physical inactivity, and race/ethnicity. African
Americans, Hispanic/Latino Americans, American Indians, and some
Asian Americans and Native Hawaiians or other Pacific Islanders
are at particularly high risk for this form of diabetes.
Researchers have made great strides in predicting who is at greatest
risk for type 1 diabetes by studying the genetic and immune markers
for this disease. Now they're applying this knowledge and a better
understanding of the autoimmune process that leads to type 1 diabetes
to prevent the disease or stop it from progressing after it is diagnosed.
The natural history study, which is taking place at all 18 TrialNet
centers, will probe the causes of type 1 diabetes by examining the
immune and metabolic events leading to disease onset. Researchers
are looking to screen first-degree relatives ages 1 to 45 and second-degree
relatives ages 1 to 20 of those with type 1 diabetes. Screening
involves a simple blood test for specific autoantibodies that appear
in at-risk people years before diabetes develops. After enrollment
in the study, participants will be closely monitored for disease
development and may be offered the opportunity to participate in
studies that try to arrest the disease process.
Most people with newly diagnosed type 1 diabetes still have some
of their beta cells. But even after type 1 diabetes is diagnosed,
the immune system keeps destroying these cells, making it harder
to control blood glucose. The second TrialNet study seeks to delay
or stop the immune destruction of beta cells. It builds on scientific
knowledge gained from earlier research on drugs that treat other
autoimmune diseases and prevent rejection of transplanted organs.
"If you still have some of your beta cells, you have an easier
time controlling your diabetes," said study chair Dr. Jay Skyler.
"This study is trying to stop the autoimmune destruction of
these cells and keep the disease from getting worse." Much
well-designed research has shown that good glucose control slows
the development of diabetes complications.
In the second study, patients are randomly assigned to one of three
groups receiving mycophenolate mofetil (MMF) alone; MMF plus daclizumab
(DZB); or placebo. Both MMF and DZB, which slow immune cell activity,
have been approved by the Food and Drug Administration to prevent
organ rejection after an organ transplant.
The study is recruiting patients ages 12 to 35 with type 1 diabetes
diagnosed in the previous three months. Participants will be closely
monitored for any possible side effects of the drugs. The most common
side effects are nausea, vomiting, diarrhea, and an increased risk
of infection. The MMF/DZB studies are taking place at six TrialNet
centers:
- Barbara Davis Center for Childhood Diabetes, Denver, CO
- Indiana University Medical Center, Indianapolis, IN
- Stanford University Medical Center, Stanford, CA
- University of Florida Medical Center, Gainesville, FL
- University of Minnesota Academic Health Center, Minneapolis, MN
- Benaroya Research Institute at Virginia Mason, Seattle, WA.
TrialNet investigators are currently developing protocols for several
other agents that have shown promise in earlier studies. Before
participating centers can begin enrolling patients, protocols must
be approved by local institutional review boards and an NIH Data
Safety Monitoring Board, which reviews each study for safety and
scientific soundness and monitors its progress.
TrialNet is funded by the National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK), the National Institute of Child Health
and Human Development, and the National Institute of Allergy and
Infectious Diseases, all parts of the National Institutes of Health
under the Department of Health and Human Services. The Juvenile
Diabetes Research Foundation International and the American Diabetes
Association also support the initiative.
For more information, see www.DiabetesTrialnet.org
, call 1-800-HALT-DM1 (1-800-425-8361) or call one of the centers
listed below.
Childrens Hospital of Los Angeles
Los Angeles, CA
1-888-835-3761 |
Children's Hospital of Pittsburgh of UPMC
University of Pittsburgh
Pittsburgh, PA
412-692-5210 |
Stanford University Medical Center
Stanford, CA
1-877-232-5182 |
University of Texas Southwestern
Medical Center at Dallas
Dallas, TX
214-648-4844 |
University of California , San Francisco
San Francisco, CA
415-514-3730 |
Benaroya Research Institute at
Virginia Mason
Seattle, WA
1-800-888-4187 |
Barbara Davis Center for Childhood Diabetes
University of Colorado
Denver, CO
Natural History Study: 1-800-572-3992
MMF/DZB: 303-315-0266 |
International Sites
The Hospital for Sick Children
Toronto, CANADA
1-866-699-1899 |
University of Florida
Gainesville, FL
1-800-749-7424, dial 1,
Ext. 334-0857 |
Vita-Salute San Raffaele University
Milan, ITALY
+39-02-2643 2818 |
University of Miami School of Medicine
Miami, FL
305-243-3781 |
University of Turku ,
Department of Pediatrics
Turku, FINLAND
+358 -2- 313 0000 |
Riley Hospital for Children
Indiana University
Indianapolis, IN
1-866-230-8486 |
University of Bristol
Bristol, UK BS10 5NB
+44- 117- 959 5337 |
Joslin Diabetes Center
Children's Hospital Boston
Boston, MA
1-800-242-5836 |
Walter and Eliza Hall Institute of Medical Research
Royal Melbourne Hospital
Burnet Clinical Research Unit
Victoria 3050 AUSTRALIA
+61-3- 93452555 |
University of Minnesota
Minneapolis, MN
1-800-688-5252 ext.58944 |
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Naomi Berrie Diabetes Center
Columbia University
Diabetes Center
New York, NY
212-851-5425 |
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