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Study Design: Observational
Conditions: Diabetes Mellitus, Type 2
Division: DEM
Duration: Phase 1: 2011 - 2014; Phase 2: 2014 - 2020
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Clinical Trials URLs:
https://clinicaltrials.gov/ct2/show/NCT01364350, https://clinicaltrials.gov/ct2/show/NCT02310724
Data Package Version Number: 1 (August 5, 2022)
DOI: 10.58020/z6n1-wc73
How to cite this dataset: Braffett, Barbara (2023). Treatment Options for Type 2 Diabetes in Adolescents & Youth Long Term Follow-Up (V1) [Dataset]. NIDDK Central Repository. https://doi.org/10.58020/z6n1-wc73
Data availability statement: Data from the Treatment Options for Type 2 Diabetes in Adolescents & Youth Long Term Follow-Up [(V1)/https://doi.org/10.58020/z6n1-wc73] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
The TODAY2 study was a longitudinal follow-up study to the TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth) study that continued the care and observation of the TODAY cohort participants beyond the end of the TODAY intervention trial. The TODAY2 study had two phases: 1) Transition of TODAY participants to non-blinded, non-randomized standard diabetes care and management with monitoring and follow-up for up to 24 months, and 2) Long-term longitudinal follow-up of the TODAY cohort based on findings from TODAY.
The primary objective of the first phase of TODAY2 was to:
The primary objective of the second phase of TODAY 2 was to track the progression of type 2 diabetes (T2D) and related comorbidities and complications in the TODAY cohort as they transitioned to young adulthood.
The primary outcome measure of the first phase of TODAY2 was to examine the persistence of effects of the TODAY treatment assignment on long-term glycemic control following discontinuation of randomized treatment.
The primary outcome measures of the second phase of TODAY2 was to assess diabetic retinopathy, microalbuminuria, overt diabetic nephropathy, peripheral diabetic neuropathy, cardiac function, arterial stiffness, and cardiovascular risk lipid values over time.
Participants in the TODAY2 study had provided informed consent and had participated in the TODAY clinical trial.
Results showed that despite increased healthcare coverage in states with expanded Medicaid, glycemic control remained poor among the TODAY cohort participants. In addition, the risk of complications due to T2D increased over time, particularly among participants of minority race and those with hyperglycemia, hypertension, and dyslipidemia.
Specimens and Study Datasets
| Serum | 13992 |
| Plasma | 13900 |
| Urine | 3590 |
| Forms |
 |
TODAY2 (2011-2014) Protocol (PDF) - 407.6 KB | |
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TODAY2 (2014-2020) Protocol (PDF) - 470.5 KB | |
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TODAY2_Data_Dictionary (PDF) - 450.1 KB | |
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TODAY2_Data_Dictionary_Screen_Reader_V1 (PDF) - 210.7 KB | |
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TODAY2_DSIC (PDF) - 146.4 KB | |
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TODAY2_Roadmap_V1 (PDF) - 182.5 KB |
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