National Study Slated on Youth Type 2 Diabetes Best Treatment

Childrens Hospital Los Angeles will chair a nationwide multicenter study comparing three treatments for type 2 diabetes in children and teens, according to a recent announcement by the National Institutes of Health (NIH).

The study is chaired by Francine R. Kaufman, MD, head of the Division of Endocrinology and Metabolism, and director of the Center for Endocrinology, Diabetes and Metabolism at the Los Angeles, California, hospital. She is the immediate past president of the American Diabetes Association (ADA) and professor of pediatrics at the Keck School of Medicine of the University of Southern California (USC).

"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," 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 NIH, part of the US Department of Health & 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.

Youth Type 2 Diabetes-A Growing Problem "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, MD, 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 Geffner.

Many drugs are available to treat type 2 diabetes in adults, but metformin is the only oral drug approved by the Food & Drug Administration (FDA) 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, Ohio; Charleston, South Carolina; Los Angeles; San Antonio, Texas; 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 8 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 & 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 US 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 ten 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 visit www.TODAYstudy.org

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. For more information, visit: www.ChildrensHospitalLA.org

National Study Slated on Youth Type 2 Diabetes Best Treatment

Therapy Skills Too Complex To Combine

Ropp Receives M-STAR Award

Ropp Receives M-STAR Award

O&P JOBS

Certified Prosthetist / Prosthetist-Orthotist (CP/CPO) Gates Prosthetics + Mobility Clinic — Mountain Home, AR

Clinic Manager – Certified Prosthetist Orthotist (CPO) – Rogers, AR

CPO

Get unlimited access!

EDGE DIRECT

Welcome Back!

Retrieve your password

Not enough quota to unlock this post

National Study Slated on Youth Type 2 Diabetes Best Treatment

Support authors and subscribe to content.

Subscribe

Related posts:

Therapy Skills Too Complex To Combine

Ropp Receives M-STAR Award

Ropp Receives M-STAR Award

O&P JOBS

Certified Prosthetist / Prosthetist-Orthotist (CP/CPO) Gates Prosthetics + Mobility Clinic — Mountain Home, AR

Clinic Manager – Certified Prosthetist Orthotist (CPO) – Rogers, AR

CPO

Get unlimited access!

EDGE DIRECT

Welcome Back!

Retrieve your password

Not enough quota to unlock this post