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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
  • Data Available for Request
  • Specimens Available for Request
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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.

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.

Eligibility 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

Obesity, Diabetes, Multidisciplinary Research, Kidney Disease

Study Type

Observational

Study Start Date

2011-03

Study End Date

2020-01

Condition

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

Clinical Trials URL

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

Keywords

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

NIDDK Division

Division of Diabetes, Endocrinology, and Metabolic Diseases

554
Participants
Target Population
Adults, Children
Sex statistics is not available for this study
Age statistics is not available for this study
Race statistics is not available for this study
Ethnicity statistics is not available for this study
Location statistics is not available for this study

Public Documents Table
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File Format
Compliance
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Datasets (33)
Datasets Table
Dataset Name
Description
# of Records
# of Variables
File Format(s)
Pulse Wave Velocity (PSW) Results Dataset
Data collected on Pulse Wave Velocity results indicating the stiffness of arteries to assess microvascular risk indicators844sas7bdat (256 KB); csv (143.62 KB)
Form PEMD Dataset
Data collected on participant physical examinations complete by clinician investigators7457sas7bdat (832 KB); csv (273.13 KB)
T2CBL Dataset
Data collected on T2CBL results7492sas7bdat (4.25 MB); csv (1.21 MB)
Form HEALTH2 Dataset
Healthcare usage data indicating usual source of healthcare, coverage for healthcare use, dental care, and cost of healthcare usage1336sas7bdat (1.69 MB); csv (265.79 KB)
Form Berlin Dataset
Berlin Sleep Questionnaire data indicating information on participant sleep behaviors and sleepiness449sas7bdat (128 KB); csv (15.53 KB)
Form DDS Dataset
Diabetes distress data indicating the degree to which items related to diabetes management are distressing/bothering the participant436sas7bdat (192 KB); csv (23.15 KB)
TME Dataset
Data collected on TME information149sas7bdat (128 KB); csv (2.8 KB)
ADDDXA Dataset
Data collected on participant Android, Gynoid, SAT, and VFAT results2236sas7bdat (384 KB); csv (440.04 KB)
Fundus Photograph Results Dataset
Data collected on fundus photographs graded according to the diabetic retinopathy scale to assess retinopathy in participants808sas7bdat (192 KB); csv (43.45 KB)
Participant Sleep (PSG) Dataset
Data collected on participant sleeping information114sas7bdat (128 KB); csv (37.53 KB)
Form MNI Dataset
Data collected to record and evaluate material needs insecurities435sas7bdat (192 KB); csv (25.86 KB)
Form MEQ Dataset
Morningness-Eveningness questionnaire data collected to record and evaluate circadian rhythm type and measure peak alertness in the morning, evening, or in between450sas7bdat (192 KB); csv (25.63 KB)
PSQI Dataset
Pittsburgh Sleep Quality Index data used to assess participant sleep quality over a 1-month time interval449sas7bdat (192 KB); csv (38.62 KB)
Echocardiogram Results Dataset
Data collected on echocardiogram results to assess cardiac function and pulse wave velocity435sas7bdat (256 KB); csv (125.66 KB)
Form HEALTH Dataset
Healthcare usage data indicating routine medical care for diabetes, routine medical care other than for diabetes, emergency medical care, and access to healthcare3325sas7bdat (1.88 MB); csv (320.79 KB)
Form BDI Dataset
Beck Depression Inventory data indicating results to 21 psychometric questions that attempt to evaluate participant depression2671sas7bdat (576 KB); csv (161.81 KB)
Form LIFE Dataset
Annual Life Events Inventory data indicating the occurrence of certain events and the mental effect of those events4064sas7bdat (2.31 MB); csv (503.45 KB)
Form VISIT Dataset
Clinical Visit Inventory data indicating menstrual and fertility status, physical exam measurements, concomitant medications, interval history, and healthcare source7629sas7bdat (3.69 MB); csv (844.67 KB)
Form PEDSQLGT Dataset
Data collected on the pediatric quality of life inventory report22sas7bdat (128 KB); csv (1.63 KB)
Speckle Dataset
Data collected on speckle results776sas7bdat (320 KB); csv (125.95 KB)
Form PHQ Dataset
Data collected on the patient health questionnaire which aimed to record and evaluate symptoms of anxiety and depression2716sas7bdat (1.19 MB); csv (268.85 KB)
Form PEDSQLG Dataset
Data collected on the pediatric quality of life inventory - adult report941sas7bdat (320 KB); csv (60.51 KB)
Form OFFSP Dataset
Offspring Questionnaire data outlining medical information on participant offspring523sas7bdat (384 KB); csv (47.82 KB)
Lipoprotein Dataset
Data collected on lipoprotein subclass levels2615sas7bdat (1.19 MB); csv (1.18 MB)
Form EATING Dataset
Data collected on the participants eating behaviors over the past three months2717sas7bdat (576 KB); csv (148.6 KB)
AME Dataset
Data collected on AME information332sas7bdat (128 KB); csv (7.13 KB)
T1CBL Dataset
Data collected on T1CBL results3658sas7bdat (1 MB); csv (525.1 KB)
Form EPWRTH Dataset
Epworth sleepiness scale data indicating the likeliness to fall asleep in certain situations in contract to just feeling tired450sas7bdat (128 KB); csv (15.87 KB)
Comorbidity Dataset
Data collected on the simultaneous presence of two or more medical conditions associated with Type-2 Diabetes677sas7bdat (320 KB); csv (89.04 KB)
Form PEDSQLGY Dataset
Data collected on the pediatric quality of life inventory - young adult report1756sas7bdat (448 KB); csv (112.8 KB)
Michigan Neuropathy Screening Instrument Results (MNSI) Dataset
Data collected on Michigan Neuropathy Screening Instrument (MNSI) results to assess peripheral diabetic neuropathy3985sas7bdat (1.88 MB); csv (400.98 KB)
Optical Coherence Tomography (OCT) Dataset
Data collected on OCT results related to retinopathy to assess microvascular complications21106sas7bdat (2.19 MB); csv (1.32 MB)
Form PREG Dataset
Data collected on participant pregnancy outcome indicating initial data, post-pregnancy data, and delivery data and perinatal complications280sas7bdat (192 KB); csv (31.37 KB)
Specimens (31,482)
Specimens Table
Specimen
Count
Plasma13900
Serum13992
Urine3590