Longitudinal Outcomes in Youth with Type 2 Diabetes—The TODAY2 Study
Presented by:
Kimberly L. Drews, MD, PhD
George Washington University, DC, USA Lorraine E. Levy Katz, MD
Children’s Hospital of Philadelphia, PA, USA Petter Bjornstad, MD
University of Colorado, CO, USA Neil H. White, MD
Washington University in St. Louis, LA, USA Jeanie B. Tryggestad, MD
University of Oklahoma, OK, USA Ruth S. Weinstock, MD, PhD
SUNY Upstate Medical University, NY, USA for the TODAY2 Study Group
The TODAY study found that type 2 diabetes in youth is a more aggressive disorder than in adults, with higher medication failure, more rapid b-cell decline, and accelerated appearance of complications.
TODAY2 is a post-intervention follow-up study of TODAY with the primary objective of monitoring progression of type 2 diabetes and complications as individuals transition to young adulthood.
The Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) Study was the first multiethnic, multicenter, randomized trial examining youth-onset type 2 diabetes (Y-T2D). TODAY2 is a follow-up study that tracked the progression of type 2 diabetes and related comorbidities and complications as the participants transition to young adulthood. Data from this cohort allows better understanding on the development of renal, cardiac, eye, and nervous system complications, as well as data on pregnancy outcomes and health care utilization in this vulnerable population.
Eligible patients in the TODAY trial were 10 to 17 years of age and treated with metformin (at a dose of 1,000 mg twice daily) to attain a HbA1c level <8% and were randomly assigned to continued treatment with metformin alone or to metformin combined with rosiglitazone (4 mg twice a day) or a lifestyle intervention program focusing on weight loss through eating and activity behaviors.
Patient population
Total number of enrollees: 517 patients in phase 2 of the follow-up.
Mean age 21.2 years, mean HbA1c of 9.3%, and mean BMI of 36.3 kg/m2.
Mean of 6.9 years since diagnosis.
Outcomes
Cardiac, renal, eye, and nervous system complications were recorded, as well as data on pregnancy outcomes and health care utilization.
The cumulative incidence of dyslipidemia and hypertension increased over 12 years.
Adolescents with T2D had increased left ventricular mass/height (g/m2.7), left ventricular ejection fraction (%), and left atrial internal dimension.
Cardiac remodeling was evident in young adults with obesity and T2D.
Renal complications
During TODAY and TODAY 2, the 12-year cumulative incidence was 40% for elevated urinary albumin and 48% for hyperfiltration.
13.8% of participants had a rapid decline in eGFR.
Loss of glycemic control was an important risk factor for development of diabetic kidney disease, together with race/ethnicity and sex.
Retinopathy
Advanced diabetic retinopathy requiring treatment was present in 9% of the TODAY cohort.
Loss of glycemic control predicted progression of diabetic retinopathy.
Neuropathy
Diabetic neuropathy was present in 28-33% of the cohort by year 12.
The prevalence of diabetic neuropathy by monofilament rose to 8% by year 12.
Diabetic neuropathy was more prevalent in males.
Pregnancy outcomes
Maternal hypertension and nephropathy were higher than previously reported.
There was no difference in retinopathy in women who had a pregnancy vs. those who did not.
All fetal complications were higher than in previous reports, including macrosomia, large for gestational age, cardiac defects, and respiratory distress.
Health care utilization
There was a trend for uninsured participants to have poorer glycemic control, but HbA1c was high in all groups.
There was a trend for lower mean HbA1c in participants with commercial insurance
Of those insured, there was inadequate coverage for diabetes drugs (10%), supplies (20%), and monitoring (15%).
The TODAY Study Group. A Clinical Trial to Maintain Glycemic Control in Youth with Type 2 Diabetes. N Engl J Med. 2012;366:2247-56.
Present disclosure: K.L. Drews, L.E. Levy Katz, P. Bjornstad, and J.B. Tryggestad: the presenters has reported that no relationships exist relevant to the contents of this presentation. N.H. White: Daiichi-Sankyo. R.S. Weinstock: Medtronic, Minimed, Diasome Pharmaceuticals, Oramed Ltd, Kowa research Inst., Boehringer Ingelheim, Eli Lilly, Insulogic LLC.
Jose C. Florez, MD, PhD
Chair, ADA Scientific Sessions Meeting Planning Committee
The 79th American Diabetes Association’s Scientific Sessions were held in San Francisco, California from June 7-11, 2019. The meeting was attended by over 15,000 professional attendees from 115 countries, … [ Read all ]
Presented by: Kimberly L. Drews, MD, PhD; Lorraine E. Levy Katz, MD; Petter Bjornstad, MD; Neil H. White, MD; Jeanie B. Tryggestad, MD; Ruth S. Weinstock, MD, PhD; for the TODAY2 Study Group
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