TODAY2 Phase 1 Immediate Post-Intervention Observational Follow-up Study

Completed

Conditions studied: Diabetes Mellitus Type 2 in Obese

In brief

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.

Key facts

Study ID

NCT01364350

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

550

Starts

2011-03-01

Expected to finish

2014-02-01

Last updated by the study team

2021-08-04

Who can join

Age: 12 and older, up to 24. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• University of Colorado Denver — Denver, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• George Washington University Biostatistics Center — Rockville, Maryland, United States
• Massachusetts General Hospital Diabetes Center — Boston, Massachusetts, United States
• Joslin Diabetes Center — Boston, Massachusetts, United States
• Saint Louis University — St Louis, Missouri, United States
• Washington University — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• State University of New York Upstate Medical University — Syracuse, New York, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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