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NIH: National Institute of Diabetes and Digestive and Kidney Diseases
NIDDK Central Repository
Citation
Braffett, Barbara (2022). Treatment Options for Type 2 Diabetes in Adolescents & Youth Long Term Follow-Up (TODAY2) (Version 1) [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 (TODAY2) [(Version 1) 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/.
Acknowledgement Statement
The TODAY2 study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the TODAY2 (https://doi.org/10.58020/z6n1-wc73) study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the TODAY2 study and does not necessarily reflect the opinions or views of the TODAY2 study, NIDDK-CR, or NIDDK.
Data Package Version
Version 1 (Updated on: Aug 05, 2022)
Resource Availability
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General Description

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.

Primary Objectives

The primary objective of the first phase of TODAY2 was to:

  • Understand the persistence of the effects of the different treatment regimens used in TODAY
  • Describe the continued evolution of beta cell function
  • Describe the development of vascular complications and risk factors for complications

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.

Outcome Measure

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.

Inclusion Criteria

Participants in the TODAY2 study had provided informed consent and had participated in the TODAY clinical trial.

Outcome

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.

Research Area

Multidisciplinary Research, Diabetes, Kidney Disease, Obesity

Study Type

Observational

Condition

Obesity Disorder, Vascular Disorder, Diabetic Retinopathy, Type 2 Diabetes Mellitus, Diabetic Kidney Disease

Medication or Intervention Agent

None

Procedure

None

Clinical Trials URL

https://clinicaltrials.gov/ct2/show/NCT02310724
https://clinicaltrials.gov/ct2/show/NCT01364350

Keywords

Type 2 Diabetes, Vascular Complications, Insulin Sensitivity and Secretion, Metformin, Microalbuminuria, Diabetic Retinopathy, Beta Cell Function, Cardiac Function, Glycemic Control

NIDDK Division

Division of Diabetes, Endocrinology, and Metabolic Diseases (DEM)

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Permitted Use(s) of the Resources

  • Use is allowed only for the specified disease(s), disorder(s), condition(s), or research area(s): Diabetes Mellitus; Obesity Disorders

Certificate of Confidentiality

  • This NIDDK-funded study is covered by a Certificate of Confidentiality. More information on what this means to Requestors is available in the NIH FAQ.

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Datasets (0)
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Specimens (31,482)
Specimens Table
Specimen
Count
Plasma13900
Serum13992
Urine3590