Phase 1 - Intervention
Early in the 2000's, there was speculation that the growing epidemic of Type 2 Diabetes (DM2) in children and adolescents would lead to the largest public health crisis of the next generation. To that point, no effective treatment strategy had been demonstrated. The U.S. National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK) sponsored TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth) to address this need. Our Section was one of 15 sites in the nation awarded this grant to participate. Recruitment lasted from March, 2004 through February 2009, and the intervention phase of the study continued through February 28, 2011.
At the time, Metformin was the only oral medication approved by the U.S. Food and Drug Administration in the treatment of DM2 in youth. The primary aim of TODAY was to compare the safety and effectiveness of three treatments for DM2 in children ages 10 to 17: metformin + placebo, metformin + rosiglitazone (approved for DM2 in adults), and metformin + intensive lifestyle intervention. All patients had to meet eligibility criteria, complete a run-in period (which includes standard diabetes education) prior to treatment, and to receive treatment for a total of 2-6 years.
We learned that the combined treatment worked better than either of the other treatments, and there we no serious safety problems in any of the treatments. We also learned that other medical conditions were present in our young participants, including high blood pressure (risk factor for heart disease), high amounts of protein in the urine (risk factor for kidney disease), high amounts of LDL and triglycerides (risk factors for heart disease), and high levels of fat in the liver (risk factor for liver disease). You can find more detailed information from the study results published in the New England Journal of Medicine, and you may view the official news release from the National Institutes of Health. You can find a selection of additional publications here.
Phase 2 - Long-term Outcomes
After the clinical trial, from March 2011 through January 2020, we continued to observe these participants as they moved from childhood and adolescence to adulthood, which was something never done before. We wanted to see how the treatments they received during TODAY impacted their diabetes in TODAY2. We also closely monitored the development of complications from DM2, including: retinopathy, neuropathy, heart disease, kidney disease, liver disease, pregnancy complications, and death. We plan to begin publishing the main findings of this phase later in 2020.
A separate set of TODAY study protocols relate to collecting blood and phenotypic information from more than 3,200 paticipants diagnosed with DM2 before age 18. Our Section was one of 24 sites collecting this data, which will be used to explore relationships between candidate genes and DM2, obesity, insulin resistance, and cardiovascular complications of insulin resistance.
For information about the studies, call 405 271-6764 or visit the TODAY Study website.