The Treatment Options for Type II Diabetes and Youth Study - gwcbi/GWDBB GitHub Wiki

Disclaimer

This is a synthetic data set inspired by the TODAY trial and it's observational follow-up. It should NOT be used for research purposes.

The original study data can be requested here: https://repository.niddk.nih.gov/studies/today/.

Reference

If you use this data please cite : The TODAY Study Group. "A Clinical Trial to Maintain Glycemic Control in Youth with Type 2 Diabetes." N Engl J Med 2012; 366:2247-2256. DOI: 10.1056/NEJMoa1109333

Usage

library(GWDBB)
summary(today_baseline)
summary(today_fu)
summary(today_lipids)

Background

General Description

Increases in childhood obesity have been accompanied by an increased prevalence of type 2 diabetes mellitus (T2DM) in children and adolescents. Research has shown the importance of adequate treatment and management on the vascular disease progression of T2DM in adults, but research on the treatment and clinical course of T2DM in youth has been limited. the TODAY (Treatment Options for Type 2 Diabetes in Adolescents & Youth) study, was a randomized clinical trial of treatment for adolescents diagnosed with T2DM.

The TODAY study tested the hypothesis that an aggressive approach to reducing insulin resistance early in the course of T2DM would prolong glycemic control and improve associated risk factors. The trial consisted of three treatment arms: metformin alone, metformin with rosiglitazone, and metformin with an intensive lifestyle intervention program (called the TODAY Lifestyle Program or TLP). Individuals between 10 and 17 years old with a diagnosis of T2DM for less than two years, a body mass index (BMI) ≥ 85th percentile, and an absence of diabetes-related autoimmunity were eligible for the study. Upon enrollment, participants entered a run-in period of 2 to 6 months, with the goals of weaning them from non-study diabetes medications, initiating treatment with metformin, providing standard diabetes education, and documenting adherence to the medication regimen. Participants were required to attain glycemic control, defined as a glycated hemoglobin level of less than 8% and measured monthly for at least 2 months, with metformin alone before proceeding. Following successful completion of the run-in period, participants were randomized to treatment with metformin and either placebo or rosiglitazone as appropriate. For those assigned to treatment with the TLP, the program was delivered in a series of in-person visits and focused on weight loss through family-based changes in eating and activity behaviors. The primary outcome measure compared between groups was time to treatment failure, defined as a persistently elevated glycated hemoglobin level (≥8%) over a period of 6 months or persistent metabolic decompensation (defined as either the inability to wean the participant from insulin within 3 months after its initiation for decompensation or the occurrence of a second episode of decompensation within 3 months after discontinuation of insulin).

Results showed rates of failure of 51.7% (120 of 232 participants) for metformin alone, 38.6% (90 of 233) for metformin plus rosiglitazone, and 46.6% (109 of 234) for metformin plus lifestyle intervention. The study found that metformin with the addition of rosiglitazone, but not the intervention program, was superior to metformin alone.

Objectives

The primary objective of the TODAY study was to compare the efficacy of three treatment regimens (metformin alone, metformin with rosiglitazone, or metformin with a lifestyle intervention program) to achieve glycemic control in children and adolescents with recent-onset type 2 diabetes.

Outcome Measure

The primary outcome measure compared between groups was time to treatment failure, defined as a persistently elevated glycated hemoglobin level (≥8%) over a period of 6 months or persistent metabolic decompensation (defined as either the inability to wean the participant from insulin within 3 months after its initiation for decompensation or the occurrence of a second episode of decompensation within 3 months after discontinuation of insulin).

Criteria

Individuals between the ages of 10 and 17 who met the following criteria were eligible for enrollment:

Diagnosis of diabetes by ADA criteria (laboratory determinations of fasting glucose ≥ 126 mg/dL, random glucose ≥ 200 mg/dL, or two-hour OGTT glucose ≥ 200 mg/dL) documented and confirmed in medical record. For patients diagnosed with diabetes during screening who have a normal fasting glucose but an elevated two-hour glucose during an OGTT, the HbA1c must be ≥ 6%.
Duration since diagnosis less than two years by date of randomization.
BMI ≥ 85th percentile documented at time of diagnosis or at screening.
Fasting C-peptide at screening (drawn at least one week after treatment for ketosis or acidosis, if applicable) > 0.6 ng/mL.
Absence of pancreatic autoimmunity.
Exclusion criteria are documented in the study protocol.