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Massachusetts General Hospital and
Joslin Diabetes Center participating in national study to identify
best treatment for type 2 diabetes in youth
BOSTON - March 15, 2004 - Massachusetts General Hospital
and Joslin Diabetes
Center will be among the 12 medical centers and affiliates nationwide
participating in a National Institutes of Health funded clinical
study comparing three treatments of type 2 diabetes in children
and teens. The study was announced today by HHS Secretary Tommy
G. Thompson.
"Researchers have learned a great deal about treating type
2 diabetes in adults, but much less is known about how best to treat
this increasingly common form of diabetes in youth," Secretary
Thompson said. "This study will answer urgent questions about
which therapy is most effective for the early stage of type 2 diabetes
in young people."
The TODAY
(Treatment Options for type 2 Diabetes in Adolescents and Youth)
study is the first clinical trial sponsored by the National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),
one of the National Institutes of Health (NIH) under the Department
of Health and Human Services, to focus on type 2 diabetes in youth.
"Formerly considered a disease of middle-aged and older adults,
type 2 diabetes is increasingly occurring in children and young
people. This study will provide us with new insights into the most
effective ways to treat these patients," said Lori M. Laffel,
M.D., M.P.H., chief of the pediatric and adolescent section at Joslin
Diabetes Center in Boston. Dr. Laffel, assistant professor of Pediatrics
at Harvard Medical School, is co-principal investigator for the
Boston part of the study.
"The diabetes epidemic, with more than 800,000 new cases per
year in the US, is now affecting all segments of the population,
including children. Effective therapy is critical, since children
will have this devastating disease for a lifetime," said David
M. Nathan, MD, the principal investigator of the TODAY study in
Boston. Dr. Nathan is director of the MGH Diabetes Center and a
professor of Medicine at Harvard Medical School.
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, most common in adults over
age 40, accounts for up to 95 percent of all diabetes cases. The
prevalence of type 2 diabetes has risen dramatically in the last
30 years. In the last 10 years alone, the prevalence of diagnosed
diabetes cases increased 50 percent, due mostly to the upsurge in
obesity.
Type 2 diabetes in both adults and children is closely linked to
being overweight, inactive, and having a family history of diabetes.
According to the 1999 to 2000 National Health and Nutrition Examination
Survey, 15 percent of young people ages 6 to 19 are overweight -
nearly triple the 1980 rate. Genetic susceptibility as well as lack
of physical activity and unhealthy eating patterns all play important
roles in determining a child's weight, the risk for type 2 diabetes,
and other complications of being overweight.
About the Study
Participants in the TODAY study will be randomly assigned to one
of three treatment groups: metformin alone, metformin and rosiglitazone
in a fixed dose combination, and metformin plus intensive lifestyle
change aimed at losing weight and increasing physical activity.
Researchers plan to enroll 750 children and teens 10 to 17 years
old diagnosed with type 2 diabetes in the past 2 years. The trial
is expected to last five years.
The main goal is to determine how well and for how long each treatment
approach controls blood glucose levels. The study will also evaluate
the safety of the treatments; the effects of the treatments on insulin
production, insulin resistance (a hallmark of type 2 diabetes in
which cells do not effectively use insulin), body composition, nutrition,
physical activity and aerobic fitness, risk factors for eye, kidney,
nerve, and heart disease, quality of life, and psychological outcomes;
the influence of individual and family behaviors on treatment response;
and the cost-effectiveness of the treatments.
Many drugs are available to treat type 2 diabetes in adults, but
metformin, which lowers the liver's production of glucose, is the
only oral drug approved by the Food and Drug Administration to treat
type 2 diabetes in children. Rosiglitazone, the other oral medicine
used in the TODAY study, belongs to a class of insulin-sensitizing
drugs called the thiazolidinediones (TZDs). It helps fat, muscle,
and liver cells respond to insulin and use glucose more efficiently.
The American
Diabetes Association is providing additional support for the
study, which is also supported in part by LifeScan, GlaxoSmithKline,
and Eli Lilly and Company.
For information about participating in the study at MGH, contact
Barbara Steiner at 866 223-8644 (toll-free) or 617 724-5985. For
Joslin participation, contact Nicole Sweatman at 800 322-6323 (toll-free),
617 732-2603 or send e-mail to TODAY@joslin.harvard.edu.
Additional
information on TODAY study.
Media Contacts: Julie
Bergan, MGH Public Affairs
Marge Dwyer,
Joslin Public Affairs
MGH Physician Referral Service: 1-800-388-4644
Information about Clinical Trials
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