TODAY2 Phase 2 Follow-up (T2P2)

National Institutes of Health (NIH)

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Other: TODAY cohort

Study type: Observational

Funder types: NIH

Identifiers

NCT02310724

DK61230-T2P2

U01DK061230 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The primary objective of T2P2 is to track the progression of T2D and related comorbidities and complications in the TODAY cohort as they transition to young adulthood. We hypothesize that:

• Youth-onset type 2 diabetes (T2D) will progress rapidly and result in high rates of diabetes-related medical complications and comorbidities.
• The rapid rate of progression is related to increased insulin resistance characteristic of puberty, worse β-cell function, degree of glycemic control, control of non-glycemic factors, and obesity itself.

Enrollment: 517 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participated in TODAY clinical trial.

Exclusion criteria

Trial design

517 participants in 1 patient group

TODAY cohort

Description:

All subjects randomized to the TODAY clinical trial are eligible to participate in T2P2. The study performs long-term observation only and administers no treatment, care, or management.

Treatment:

Other: TODAY cohort