Serious Complications from Youth-onset Type 2 Diabetes Arise by Young Adulthood

“The original TODAY study showed that youth-onset type 2 diabetes is distinct from adult-onset diabetes – it is both more aggressive and more difficult to control,” said Dr. Barbara Linder, NIDDK project scientist for TODAY. “By following this unique disease course, TODAY2 shows the devastating complications that can develop in what should be the prime of these young people’s lives.”

TODAY2 involved 500 original participants from the TODAY study, which began in 2004. TODAY was the first major comparative effectiveness trial for the treatment of type 2 diabetes in youth. The study compared three treatments for managing blood glucose: metformin alone, metformin plus rosiglitazone, and metformin plus an intensive lifestyle intervention. Metformin is the only oral medication approved by the U.S. Food and Drug Administration to treat type 2 diabetes in youth.

At the time of enrollment, participants were between the ages of 10-17, had been diagnosed with type 2 diabetes for fewer than two years, and were overweight or had obesity. The average age of participants after the TODAY2 follow-up was 26 years.

Participants in TODAY2 were monitored annually for signs of diabetes complications, including heart disease, kidney disease, diabetic foot complications, and to report other health events. Diabetic eye disease was assessed once during the study, at the seven-year study visit.

Overall, researchers saw a steady decline in blood glucose control over 15 years. In addition:

• 67% of participants had high blood pressure
• Nearly 52% had dyslipidemia, or high fat levels in the blood nearly 55% had kidney disease
• 32% had evidence of nerve disease
• 51% had eye disease

Rates did not differ based on the original TODAY study treatment group assignment.

In addition, certain participants had a higher likelihood to develop multiple complications over time, with 28% developing two or more over the follow-up period. Participants who belonged to a minority racial or ethnic group, or who had high blood glucose, high blood pressure, and dyslipidemia were at higher risk for developing a complication.

“TODAY and TODAY2 bring awareness to all medical providers and families that we need to identify children at risk for type 2 diabetes earlier and aggressively treat them. The complications related to type 2 diabetes develop and progress at an accelerated pace compared to adults with type 2 diabetes. This is very worrisome as these youth enter young adulthood,” said TODAY2 study Vice-chair Rose Gubitosi-Klug, MD, Division Chief of Pediatric Endocrinology at UH Rainbow Babies & Children’s Hospital and Professor of Pediatrics at Case Western Reserve University School of Medicine.

The TODAY study’s diverse cohort is representative of the U.S. youth diagnosed with type 2 diabetes. Study participants had regular, intensive diabetes management through the study at no cost during the original TODAY trial, which researchers note may have actually lowered the rate of complications.

“TODAY and TODAY2 have been instrumental in understanding and treating type 2 diabetes in youth,” said NIDDK Director Dr. Griffin P. Rodgers. “In addition to finding better prevention methods, discovering new and better treatment options to manage type 2 diabetes in youth will be key to ensuring their healthy futures.”

The TODAY and TODAY2 studies were conducted at UH Rainbow and 14 other centers in the U.S. The George Washington University, Washington, D.C., served as the data coordinating center.

This work was completed with funding from NIDDK/NIH grant numbers U01-DK61212, U01-DK61230, U01-DK61239, U01-DK61242, and U01-DK61254; the National Center for Research Resources General Clinical Research Centers Program; and the NCRR Clinical and Translational Science Award Program.

TODAY received additional support from Becton, Dickinson and Company; Bristol-Myers Squibb; Eli Lilly and Company; GlaxoSmithKline; LifeScan, Inc.; Pfizer; and Sanofi Aventis.