Findings from NIH-funded study underscore importance of early, intensive treatment
July 28, 2021 – People with type 2 diabetes diagnosed during youth have a high risk of developing complications at early ages and have a greater chance of multiple complications within 15 years after diagnosis. The findings are the culmination of a first-of-its-kind trial funded largely by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health.
Within 15 years of a type 2 diabetes diagnosis, 60% of participants had at least one diabetes-related complication, and nearly a third of participants had two or more complications, according to results of the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY)(link is external) follow-up study, called TODAY2. The findings were published in the New England Journal of Medicine(link is external).
“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.
“Compared to what we see in adults with type 2 diabetes, the participants in TODAY2 developed complications much earlier in their disease course and at a much faster pace over time,” said TODAY2 study chair Dr. Philip Zeitler, professor of pediatrics-endocrinology at the University of Colorado School of Medicine. “This study shows the importance of treating youth-onset type 2 diabetes intensively from the beginning and using all available approaches to control blood glucose and prevent, delay, or aggressively treat developing complications.”
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 15 centers in the U.S. and 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.
The NIDDK, a component of the NIH, conducts and supports research on diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition and obesity; and kidney, urologic and hematologic diseases. Spanning the full spectrum of medicine and afflicting people of all ages and ethnic groups, these diseases encompass some of the most common, severe and disabling conditions affecting Americans. For more information about the NIDDK and its programs, see https://www.niddk.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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