Although type 2 diabetes mellitus (T2D) was formerly a disease exclusively of adulthood, youth-onset T2D now represents a substantial percentage of new cases of diabetes in children. When T2D onset occurs in youth (1) there is a substantial risk that diabetic complications will lead to major morbidity, mortality, economic loss, and reduced quality of life by young adulthood, (2) the consequences may disproportionately affect ethnic minorities, and (3) ?-cell failure and development of diabetes-related complications and comorbidities may be more rapid than in either adult-onset T2D or youth-onset T1D. Existing studies have been inadequate to draw definitive conclusions regarding rates of comorbidities, their long-term impact, and hard clinical endpoints. The TODAY clinical trial recruited 699 youth to address treatment modalities and start to document disease progression. Long-term observational follow-up (TODAY2) of this large, thoroughly characterized, cohort closely followed from near disease onset is an unparalleled opportunity to test the hypothesis that youth-onset T2D represents a more aggressive presentation of the disorder by direct comparison to equivalent longitudinal studies in adult-onset T2D and youth-onset T1D. In addition, the extensive phenotyping and close monitoring of this cohort from soon after diagnosis will address the question of whether the apparent difference in youth- onset T2D represents biological difference, is a consequence of poor metabolic control, or is related to the pubertal state. Longitudinal follow-up will also provide the opportunity to more fully understand the effects of puberty and transition out of puberty on youth-onset T2D, as well as the disease course of individuals who appear to have maintained durable control into the post-pubertal years. Finally, study of this cohort will add to our understanding of the challenges and burdens borne by individuals with youth-onset T2D as they transition into adulthood. To address these outcome questions, TODAY2 will follow the TODAY participants at annual in- person visits, semi-annual telephone contact, and quarterly telephone and electronic communications for a comprehensive and systematic approach to documenting outcomes indicating the progression of T2D, ?-cell function, and diabetes-related comorbidities and complications.

Public Health Relevance

For adolescents with T2D, there is a substantial risk that diabetic complications will occur in what should be their most productive period of life and will disproportionately affect ethnic minorities. The proposed research will address gaps in knowledge about this disease by continuing to follow a well-studied group of adolescents with T2D to identify causes and factors related to development of complications in young adulthood.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
2U01DK061230-13
Application #
9108586
Study Section
Special Emphasis Panel (ZDK1-GRB-6 (J3)S)
Program Officer
Bremer, Andrew
Project Start
2001-09-30
Project End
2020-04-30
Budget Start
2016-08-01
Budget End
2017-04-30
Support Year
13
Fiscal Year
2016
Total Cost
$7,930,830
Indirect Cost
$675,537
Name
George Washington University
Department
Biostatistics & Other Math Sci
Type
Schools of Public Health
DUNS #
043990498
City
Washington
State
DC
Country
United States
Zip Code
20052
Berkowitz, Robert I; Marcus, Marsha D; Anderson, Barbara J et al. (2017) Adherence to a lifestyle program for youth with type 2 diabetes and its association with treatment outcome in the TODAY clinical trial. Pediatr Diabetes :
Arslanian, Silva; El Ghormli, Laure; Bacha, Fida et al. (2017) Adiponectin, Insulin Sensitivity, ?-Cell Function, and Racial/Ethnic Disparity in Treatment Failure Rates in TODAY. Diabetes Care 40:85-93
Kriska, Andrea; El Ghormli, Laure; Copeland, Kenneth C et al. (2017) Impact of lifestyle behavior change on glycemic control in youth with type 2 diabetes. Pediatr Diabetes :
Rockette-Wagner, Bonny; Storti, Kristi L; Edelstein, Sharon et al. (2017) Measuring Physical Activity and Sedentary Behavior in Youth with Type 2 Diabetes. Child Obes 13:72-77
Chadwick, Jennifer Q; Van Buren, Dorothy J; Morales, Elisa et al. (2017) Structure to utilize interventionists' implementation experiences of a family-based behavioral weight management program to enhance the dissemination of the standardized intervention: The TODAY study. Clin Trials 14:406-412
Kelsey, Megan M; Geffner, Mitchell E; Guandalini, Cynthia et al. (2016) Presentation and effectiveness of early treatment of type 2 diabetes in youth: lessons from the TODAY study. Pediatr Diabetes 17:212-21
Gandica, Rachelle; Zeitler, Phil (2016) Update on Youth-Onset Type 2 Diabetes: Lessons Learned from the Treatment Options for Type 2 Diabetes in Adolescents and Youth Clinical Trial. Adv Pediatr 63:195-209
Walders-Abramson, Natalie; Anderson, Barbara; Larkin, Mary E et al. (2016) Benefits and barriers to participating in longitudinal research of youth-onset type 2 diabetes: Results from the TODAY retention survey. Clin Trials 13:240-3
Marcus, M D; Wilfley, D E; El Ghormli, L et al. (2016) Weight change in the management of youth-onset type 2 diabetes: the TODAY clinical trial experience. Pediatr Obes :
Klingensmith, Georgeanna J; Pyle, Laura; Nadeau, Kristen J et al. (2016) Pregnancy Outcomes in Youth With Type 2 Diabetes: The TODAY Study Experience. Diabetes Care 39:122-9

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