Philip Zeitler, MD, PhD
Results from Longitudinal Outcomes in Youth with Type 2 Diabetes—The TODAY2 Study, a post-intervention follow-up to the TODAY Study, will be presented at 1:45 p.m. Saturday in S-154 (South, Upper Mezzanine Level). ADAMeetingNews.org asked TODAY2 Study Chair Philip Zeitler, MD, PhD, to discuss the background, objective, and the significance of the study. Dr. Zeitler is Professor of Pediatrics–Endocrinology and Section Head of Endocrinology at the University of Colorado School of Medicine, and Medical Director of the Children’s Hospital Clinical & Translational Research Center.
Study Background
Dr. Zeitler: The TODAY Study was the first multiethnic, multicenter, randomized trial examining youth-onset type 2 diabetes and remains unique in this category. The TODAY cohort consists of racially and ethnically diverse participants with youth-onset type 2 diabetes who have been rigorously characterized and followed longitudinally since 2004 to better understand the clinical course of complications and comorbidities of youth-onset type 2 diabetes. TODAY randomized 699 participants and sought to compare metformin alone, metformin plus rosiglitazone, and metformin plus an intensive lifestyle program on time to treatment.
The primary outcome of TODAY, reported in 2012, showed that 45.6% of the cohort experienced treatment failure, with the highest rate being in the metformin monotherapy group, which was significantly higher than that of the metformin plus rosiglitazone group. The rate of failure for the metformin plus intensive lifestyle group was intermediate and was not different from either of the other groups.
After the conclusion of the TODAY trial in 2011, all TODAY participants were invited to remain in TODAY2, which resulted in a cohort of 517 individuals with a current average age of 25 and diabetes duration of 12 years.
Objective
Dr. Zeitler: The primary objective of TODAY2 is to track the progression of type 2 diabetes and related comorbidities and complications as the participants transition to young adulthood. These individuals were seen for an annual visit in one of 15 clinical centers, during which a variety of outcomes were obtained, including laboratory testing, echocardiograms, vascular testing, and eye exams. In addition, medical history was obtained for any targeted diabetes events—such as amputation, heart disease, kidney disease, vision problems, death, etc.—that occurred through their regular care. If such events were identified, medical records were obtained and the presence of these targeted diabetes-related events was adjudicated according to accepted national diagnostic guidelines.
Significance
Dr. Zeitler: This cohort now allows the TODAY Study Group to report on extensive experience in the development of renal, cardiac, eye, and nerve complications, as well as data on pregnancy outcomes and healthcare utilization in this vulnerable population. This will be important information for providers and policymakers addressing the growing population of individuals with youth-onset type 2 diabetes.
Given the very poor outcomes for many individuals with youth-onset type 2 diabetes and the challenges in effectively treating this disorder once it occurs in adolescence, there’s a substantive need for research focused on better understanding the antecedents of youth-onset type 2 diabetes in order to identify effective approaches to preventing the development of the disorder in the first place.
