A multi-center NIH clinical diabetes study reported in the New England Journal of Medicine that people with type 2 diabetes diagnosed during youth have a very high risk of developing complications at early ages and have a greater chance of multiple complications within 15 years after diagnosis. The Berrie Center was one of the study sites for this study, called the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Trial and the Berrie Center principal investigator was Robin Goland, MD. The findings are the culmination of this important study, funded by the National Institutes of Health (NIH).
Within 15 years of a type 2 diabetes diagnosis, 60% of participants whose mean age was 26 years old had at least one diabetes-related complication, and nearly a third of participants had two or more complications. “These are exceptionally high rates of diabetes complications, occurring in very young participants. The negative public health consequences of type 2 diabetes occurring at a young age are enormous.,” said Dr. Goland.
The TODAY study began in 2004. The study compared three treatments for managing blood glucose: metformin alone, metformin plus rosiglitazone, and metformin plus an intensive lifestyle intervention. 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 follow-up study was called TODAY2. Participants in TODAY2 returned to usual diabetes care and were monitored annually for signs of diabetes complications, including heart disease, kidney disease, and diabetic foot complications. 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 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 the Berrie Center 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.