By continuing to follow the cohort from the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study sponsored by the National Institutes of Health (NIH), researchers can now report on the extensive development of severe renal, cardiac, eye, nerve, and pregnancy complications in early adulthood in patients with youth-onset type 2 diabetes (Y-T2D). Results from this follow up study, TODAY2, presented today at the American Diabetes Association’s® (ADA’s) 79th Scientific Sessions® at the Moscone Convention Center in San Francisco, show an accelerating rate of serious complications within the last five years and point to the increased need for more aggressive management of the disease to minimize or prevent the development of serious complications in individuals with Y-T2D.
“Our findings indicate the development of diabetes-related complications in individuals with youth-onset disease is at least as rapid as it is in individuals who develop the disease later on in life. Since these individuals are battling the disease at a younger age, they are experiencing life-changing health consequences caused by type 2 diabetes at the earliest stages of adulthood. This means there will be a substantial burden of diabetes-related complications that will require even more intense management as they age,” said Philip S. Zeitler, MD, PhD, section head of pediatric endocrinology at the University of Colorado School of Medicine and the chair of the department of endocrinology at the Children’s Hospital Colorado.
TODAY was the first multi-ethnic, randomized trial examining individuals who had the onset of type 2 diabetes (T2D) before age 18 years (Y-T2D) and remains unique in this area. When the study began in 2004, it enrolled 699 participants between the ages of 10 and 17 years and sought to compare treatment using metformin (the only FDA-approved medication for T2D in youth), to using metformin combined with rosiglitazone (an oral drug that improves the action of the body’s own insulin), and to using metformin with a lifestyle-intervention program focused on weight loss through healthier eating and increased physical activity. The primary outcome was loss of glycemic control, defined as a glycated hemoglobin level of at least 8% for six months or sustained metabolic decompensation requiring insulin.
Results of the original TODAY study found monotherapy with metformin was associated with sustained glycemic control in approximately half (46.5%) of children and adolescents with T2D. The addition of rosiglitazone, but not an intensive lifestyle intervention, was superior to metformin alone. Detailed analysis of the data further showed non-Hispanic black participants had particularly poor outcomes, with more than 50% having higher than desirable A1C levels within 12 months of initial metformin treatment. Other major outcomes from TODAY include the demonstration that pancreatic insulin secretion decreased at a rate of 20-35% per year, exceeding that reported in adults. In addition, complications and comorbidities were found to be common in this population of individuals with Y-T2D at the time of diagnosis and increased steadily over the time.
At the conclusion of the study in 2011, all TODAY participants were invited to remain in TODAY2, an observational follow-up study. Since then, 517 participants, with a current average age of 25 years and average T2D duration of 12 years, have been seen annually in one of the 15 clinical centers, during which information was gathered using laboratory testing, echocardiograms, vessel function testing, and eye examinations. Researchers also collected the participant’s medical history at each visit to chart any diabetes-related events, such as amputation, heart disease, kidney problems, or vision issues.
Findings from TODAY2 illustrate the occurrence of major diabetes-related events in this young adult population, including heart attacks, chronic kidney disease, advanced diabetic retinal disease, early signs of diabetic nerve disease, and complications in the offspring of pregnancies. Additional results of TODAY2 indicate that more than 50% of the participants had abnormal lipids and more than 60% had high blood pressure. Kidney function assessments show about 40% of participants had evidence for early diabetic kidney disease, and retinal examinations indicate almost 50% of participants had evidence for diabetic retinal disease. Additionally, up to 33% of participants demonstrated early signs of diabetic nerve disease, which was more common in those with worse glucose control. Within the 306 pregnancies reported by participants in TODAY2, 25% of the 236 pregnancies with known outcomes resulted in miscarriage or fetal death, and 24% resulted in preterm births.
“Many of these risk factors and overt complications are not being as vigorously managed as these data suggest is needed,” said Dr. Zeitler. “For example, we found that, despite high blood pressure or abnormal lipids, fewer than half of the participants were on medications to treat these issues. The TODAY2 data suggest healthcare professionals need to overcome hesitancy – whether due to the young age of patients or lack of familiarity with the pharmacotherapy – to aggressively treat young patients battling youth-onset type 2 diabetes to minimize the damage from serious diabetes-related complications. This intensive management depends on coordinated care by teams of providers familiar with the unique aspects of management and the care guidelines for this population.”
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