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

Summary

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.

Conditions

• Diabetes Mellitus Type 2 in Obese

Interventions

OTHER

standard of care in general clinical practice

Participants consenting to receive study-provided care may be treated with metformin, insulin, statin, and ace-inhibitor, as needed for glycemic control and for comorbid conditions.

Sponsors & Collaborators

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

  lead NIH

Principal Investigators

• Silva Arslanian, MD · University of Pittsburgh

• Sonia Caprio, MD · Yale University

• Leona Cuttler, MD · CWRU Rainbow Babies and Children's Hospital

• Ken Copeland, MD · University of Oklahoma Health Science Center

• Mitch Geffner, MD · Children's Hospital Los Angeles

• Robin Goland, MD · Columbia University Naomi Berrie Diabetes Center

• Lorraine Katz, MD · Children's Hospital of Philadelphia

• Lori Laffel, MD · Joslin Diabetes Center

• Barbara Linder, MD PhD · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

• Jane Lynch, MD · The University of Texas Health Science Center at San Antonio

• Siripoom McKay, MD · Baylor College of Medicine

• David Nathan, MD · Massachusetts General Hospital

• Sherida Tollefsen, MD · Saint Louis University Health Sciences Center

• Ruth Weinstock, MD PhD · State University of New York - Upstate Medical University

• Neil White, MD · Washington University School of Medicine

• Phil Zeitler, MD PhD · University of Colorado, Denver

• Kathryn Hirst, PhD · George Washington University

Eligibility

Min Age

12 Years

Max Age

24 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-03-31

Primary Completion

2014-02-28

Completion

2014-02-28

Countries

• United States

Study Locations