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Citation
Braffett, Barbara (2022). TODAY2 Control Echocardiogram Sample Data Collection Study (TODAY2 ECHO) (Version 1) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/pr1r-5t62
Data Availability Statement
Data from the TODAY2 Control Echocardiogram Sample Data Collection Study (TODAY2 ECHO) [(Version 1) https://doi.org/10.58020/pr1r-5t62] 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 ECHO 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 ECHO (https://doi.org/10.58020/pr1r-5t62) 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 ECHO study and does not necessarily reflect the opinions or views of the TODAY2 ECHO study, NIDDK-CR, or NIDDK.
Data Package Version
Version 1 (Updated on: Aug 05, 2022)
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General Description

The TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth) study was a multi-center randomized clinical trial (2004-2011). Youth aged 10-17 years diagnosed with type 2 diabetes (T2D) for less than 2 years were enrolled. The trial compared the efficacy of three treatment arms: (1) metformin alone, (2) metformin plus rosiglitazone, and (3) metformin plus an intensive lifestyle intervention. The TODAY trial concluded in February 2011 and was followed by TODAY2 (2011-2020), an observational longitudinal study to continue follow-up of the TODAY cohort to document the progression of diabetes and its complications and related comorbidities.

In the last year of the TODAY study, the cohort was assessed by echocardiography. A follow-up echocardiogram was completed 5 years later during the TODAY2 study. During TODAY2, the study also collected comparative echocardiogram control data in individuals without diabetes and hypertension, and also performed a one-time collection of data and blood for storage of serum and plasma in these consented control participants.

Primary Objectives

The purpose of the echocardiogram non-diabetic, non-hypertensive, obese and lean control participants (TODAY2 ECHO) study was to collect control biospecimens and data to compare with the outcomes from the TODAY/TODAY2 studies.

Inclusion Criteria

There were two control sample groups: (1) obese and not diabetic, and (2) lean and not diabetic.

Control Group 1: Obese Controls Eligibility Criteria

Inclusion

  • Body mass index (BMI) > 30 kg/m2
  • Age 18-30 years
  • Allow blood draw for testing HbA1c
  • Signed informed consent form

Exclusion

  • Pregnant female
  • Diagnosed with diabetes (either type 1 or type 2) or HbA1c > 6.5% determined by central lab analysis of screening blood drawn
  • Diagnosed with hypertension or taking anti-hypertensive medication or screening blood pressure ≥ 130/80

Control Group 2: Lean Controls Eligibility Criteria

Inclusion

  • Body mass index (BMI) 18.5 to 25 kg/m2
  • Age 18-30 years
  • Allow blood draw for testing HbA1c
  • Signed informed consent form

Exclusion

  • Pregnant female
  • Diagnosed with diabetes (either type 1 or type 2) or HbA1c > 6.5% determined by central lab analysis of screening blood drawn
  • Diagnosed with hypertension or taking anti-hypertensive medication or screening blood pressure ≥ 130/80
Outcome

The TODAY2 ECHO is a cohort of non-diabetic controls biospecimens and associated data consented for general research use. These resources may be requested separate or in combination with other TODAY Network associated studies, as such outcomes specific to the TODAY2 ECHO control cohort are not provided. Please refer to specific TODAY Network study(ies) for related outcomes.

Research Area

Obesity, Diabetes, Multidisciplinary Research

Study Type

Observational

Study Sites

2

Condition

Obesity Disorder, Type 2 Diabetes Mellitus

Medication or Intervention Agent

Behavioral Therapy, Rosiglitazone, Metformin

Procedure

None

Keywords

Echocardiography, Diabetese Mellitus, Type 2, Comorbidities

NIDDK Division

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

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