TODAY2 Phase 1 Immediate Post-Intervention Observational Follow-up Study (T2P1)

National Institutes of Health (NIH)

Status: Completed

Conditions: Diabetes Mellitus Type 2 in Obese

Treatments: Other: standard of care in general clinical practice

Study type: Observational

Funder types: NIH

Identifiers

NCT01364350

DK61230-T2P1

Details and patient eligibility

About

The purpose of this study is to continue to follow participants in the TODAY clinical trial as they transition to non-blinded, non-randomized standard diabetes care and management with monitoring and follow-up for up to 24 months (phase 1), during which time the TODAY data are analyzed and findings interpreted to develop a long-term observational protocol (phase 2). Data are collected during phase 1 for descriptive purposes; there is no primary hypothesis.

Full description

TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) was a multi-center study of the optimal approach to treatment of type 2 diabetes (T2D) in children and adolescents. The TODAY clinical trial of experimental interventions ended in February 2011. It is followed by TODAY2, a longitudinal study to continue the care and observation of the TODAY cohort beyond the end of the TODAY intervention trial. TODAY2 consists of two phases.

1. First is the immediate transition of TODAY participants to non-blinded, non-randomized standard diabetes care and management with monitoring and follow-up for up to 24 months. During this period, the findings of TODAY are analyzed and interpreted by the study group.
2. The second phase is a protocol for long-term longitudinal follow-up of the TODAY cohort, based on findings from TODAY.

The primary objective of the first phase of TODAY2 is to continue to follow the TODAY subjects for up to 24 months in order to begin to:

• understand the persistence of the effects of the different treatment regimens used in TODAY,
• describe the continued evolution of beta cell function, and
• describe the development of vascular complications and risk factors for complications.

Enrollment: 550 patients

Sex: All

Ages: 12 to 24 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Participated in the TODAY clinical trial.
• Provided informed consent to participate in T2P1.

Trial design

550 participants in 1 patient group

TODAY cohort

Description:

The cohort of participants diagnosed with type 2 diabetes ages 10 to \<18 and obese at time of diagnosis who participated in the TODAY clinical trial are recruited, consented and followed.

Treatment:

Other: standard of care in general clinical practice