LOS ANGELES, March 23, 2004 (PRIMEZONE) -- Childrens Hospital Los Angeles will chair a nationwide multicenter study comparing three treatments for type 2 diabetes in children and teens, according to an announcement (March 15, 2004) by the National Institutes of Health.
The study is chaired by Francine R. Kaufman, M.D., head of the Division of Endocrinology and Metabolism, and director of the Center for Endocrinology, Diabetes and Metabolism at Childrens Hospital Los Angeles. She is the immediate past-president of the American Diabetes Association, and professor of pediatrics at the Keck School of Medicine of the University of Southern California.
"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," Dr. Kaufman 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 Institutes of Health (NIH), part of the Department of Health and Human Services, to focus on type 2 diabetes in youth. Participants will be randomly assigned to one of three treatment groups: metformin alone; metformin and rosiglitazone in 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 two years. The trial is expected to last five years.
The TODAY study's main goal is to determine how well and for how long each treatment approach controls blood glucose levels. The study also will 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.
"For people with type 2 diabetes, it's critical to give the safest, most effective therapy as early as possible in order to delay the complications of the diseases," said Barbara Linder of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the part of the NIH that is funding the study. "Yet we can't assume that therapies used in adults will work as well, and as safely, in children and teens."
"What was once a disease of our grandparents is now a disease of our children," said Mitchell Geffner, M.D., principal investigator of the study at Childrens Hospital Los Angeles, and a professor of Pediatrics at the Keck School of Medicine. "The lifestyles of our children have radically changed in the past 20 years, and especially in the past five years. At Childrens Hospital Los Angeles, more and more youngsters are being diagnosed with type 2 diabetes, a once unknown disease in children."
The longer a person has diabetes, the greater the chances of developing serious damage to the eyes, nerves, heart, kidneys and blood vessels. "Yet we're seeing kids in their late teens who are already developing the complications of type 2 diabetes," noted Dr. Geffner.
Many drugs are available to treat type 2 diabetes in adults, but metformin is the only oral drug approved by the Food and Drug Administration to treat type 2 diabetes in children. Considered first-line therapy by most pediatric endocrinologists, it works by lowering the liver's production of glucose. Rosiglitazone, the other oral medicine used in the TODAY study, belongs to a class of insulin-sensitizing drugs called the thiazolidinediones (TZDs). It helps muscle cells respond to insulin and use glucose more efficiently.
TODAY is the first clinical study to look at the effects of intensive lifestyle change aimed at lowering weight by cutting calories and increasing physical activity in youths with type 2 diabetes. The NIDDK-sponsored LookAHEAD trial, currently under way, is studying the benefits of weight loss in adults with type 2 diabetes.
Once seen only in adults, type 2 diabetes has been rising steadily in all children, especially minority adolescents -- African Americans, Hispanic Americans and American Indians -- according to reports from clinics around the country. Studies in Cincinnati, Charleston, Los Angeles, San Antonio and other cities report that childhood type 2 diabetes cases have risen dramatically since 1994, when less than five percent of new childhood diabetes cases were type 2. By 1999, type 2 diabetes accounted for eight to 45 percent of new childhood diabetes cases, depending on location. Some diabetes centers are now seeing more new cases of type 2 diabetes than type 1, an autoimmune disease.
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 1999-2000 National Health and Nutrition Examination Survey (NHANES), 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.
The TODAY trial is one of two NIDDK-funded studies that will focus on type 2 diabetes in children. An upcoming prevention study will seek to develop cost-effective interventions that can be widely applied in schools across the country. "Obesity and type 2 diabetes are among the most serious health challenges facing America's youth today," said Health and Human Services Secretary Tommy G. Thompson. "We need to do all we can to develop strategies that encourage healthy eating and active lifestyles in our children."
About 18.2 million people -- 6.3 percent of the U.S. population -- have diabetes. It is the main cause of kidney failure, limb amputation 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 affects up to 1 million people in the United States. This form of diabetes develops when the body's immune system destroys the insulin-producing beta cells of the pancreas. Type 1 diabetes usually strikes children and young adults, who need several insulin injections a day, or an insulin pump, to survive.
The American Diabetes Association is providing additional support for the study, which also is supported in part by LifeScan, GlaxoSmithKline, and Eli Lilly and Company.
For more information about the TODAY trial, call (323) 671-6052, or see www.TODAYstudy.org.
Founded in 1901, Childrens Hospital Los Angeles has been treating the most seriously ill and injured children in Los Angeles for more than a century, and it is acknowledged throughout the United States and around the world for its leadership in pediatric and adolescent health. Childrens Hospital is one of America's premier teaching hospitals, training more young pediatricians than any other health care facility in California through its association with the Keck School of Medicine of the University of Southern California since 1932. It is a national leader in pediatric research.
Since 1990, U.S. News & World Report and its panel of board-certified pediatricians have named Childrens Hospital Los Angeles one of the top pediatric facilities in the nation.
Visit our website: www.ChildrensHospitalLA.org
TODAY Participating Centers
Study Chair: Francine R. Kaufman, M.D.
Head of the Division of Endocrinology and
Metabolism and Director of the Center for
Endocrinology, Diabetes and Metabolism
Childrens Hospital Los Angeles Media
Contacts: Steve Rutledge (323) 669-4121 and
Roberta Nichols (323) 669-4133
Coordinating Center: George Washington University
Washington, D.C.
Principal Investigator: Dr. Kathryn Hirst
Media Contact: Barbara Porter, (202) 994-3121
Childrens Hospital Los Angeles
Los Angeles, CA
Principal Investigator: Dr. Mitchell Geffner
Trial Coordinator: Veronica Barraza (323) 671-6052
Media Contacts: Steve Rutledge (323) 669-4121
and Roberta Nichols (323) 669-4133
University of Colorado Health Sciences Center
The Children's Hospital
Denver, CO
Principal Investigator: Dr. Philip Scott Zeitler
Trial Coordinator: Nicole Celona-Jacobs (303) 869-3212
Media Contact: Natalie Goldstein (303) 861-3970
Yale University
New Haven, CT
Principal Investigator: Dr. Sonia Caprio
Trial Coordinator: Cindy Guandalini (203) 764-6652
Media Contact: Karen Peart (203) 432-1326
Massachusetts General Hospital
Joslin Diabetes Center
Boston, MA
Principal Investigators: Dr. David Nathan and Dr. Lori Laffel
Trial Coordinators: Barbara Steiner (617) 724-5985
and Nicole Sweatman (617) 732-2603
Media Contacts: Julie Bergan (617) 726-0274
and Marge Dwyer (617) 732-2415
Washington University School of Medicine
St. Louis University School of Medicine
St. Louis, MO
Principal Investigators: Dr. Neil White and Dr. Sherida Tollefsen
Trial Coordinators: Tracy Jones (314) 286-1165
and Theresa Whelan (314) 577-5611
Media Contacts: Nicole Vines (314) 286-0105
and Nancy Solomon (314) 977-8017
State University of New York (SUNY)
Upstate Medical University
Syracuse, NY
Principal Investigator: Dr. Ruth Weinstock
Trial Coordinator: Kelly Duncan (315) 464-3878
Media Contact: Darryl Geddes (315) 464-4828
Case Western Reserve University School of Medicine
Cleveland, OH
Principal Investigator: Dr. William Dahms
Trial Coordinator: Paul McGuigan (216) 844-3661
Media Contacts: Janice Guhl (216) 844-1524
and Eric Sandstrom (216) 844-1524
University of Oklahoma Health Sciences Center
Oklahoma City, OK
Principal Investigator: Dr. Kenneth Copeland
Trial Coordinator: Carol Comp (405) 271-8001, x43075
Media Contact: Tawney Poulsen (405) 271-5067
The Children's Hospital of Philadelphia
Philadelphia, PA
Principal Investigator: Dr. Charles Stanley
Trial Coordinator: Cathy Carchidi (267) 426-5492
Media Contacts: Joey McCool (267) 426-6070
Children's Hospital of Pittsburgh
Pittsburgh, PA
Principal Investigator: Dr. Silva Arslanian
Trial Coordinator: Kristin Kolenc (412) 692-5928
Media Contact: Melanie Finnigan (412) 692-5016
Baylor College of Medicine
Houston, TX
Principal Investigator: Dr. Morey Haymond
Trial Coordinator: Sue McGirk (832) 822-3063
Media Contact: Lori Williams (713) 798-4710
University of Texas Health Sciences Center
San Antonio, TX
Principal Investigator: Dr. Daniel Hale
Trial Coordinator: Cynthia Trevino (866) 764-6450
Media Contact: Will Sansom (210) 567-2579