Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY)
Completed · Phase 3
Conditions studied: Diabetes Mellitus, Type II
In brief
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) has sponsored a consortium of investigators to conduct a clinical treatment trial, Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY). The primary objective of the TODAY trial is to compare the efficacy of three treatment arms on time to treatment failure based on glycemic control. The secondary aims are to: * compare and evaluate the safety of the three treatment arms; * compare the effects of the three treatments on the pathophysiology of type 2 diabetes (T2D) with regards to beta cell function and insulin resistance, body composition, nutrition, physical activity and aerobic fitness, cardiovascular risk factors, microvascular complications, quality of life, and psychological outcomes; * evaluate the influence of individual and family behaviors on treatment response; and * compare the relative cost effectiveness of the three treatment arms. The three treatment regimens are: (1) metformin alone, (2) metformin plus rosiglitazone, and (3) metformin plus an intensive lifestyle intervention called the TODAY Lifestyle Program (TLP). The study recruits patients over a three-year period and follows patients for a minimum of two years. Patients are randomized within two years of the diagnosis of T2D.
Key facts
- Study ID
- NCT00081328
- Run by
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- People needed
- 699
- Starts
- 2004-05-01
- Expected to finish
- 2014-02-01
- Last updated by the study team
- 2021-07-30
Who can join
Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Children's Hospital Los Angeles — Los Angeles, California, United States
- University of Colorado Health Sciences Center, The Children's Hospital — 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 Health Sciences Center — St Louis, Missouri, United States
- Washington University Department of Pediatrics — 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 — Cleveland, Ohio, United States
- University of Oklahoma — 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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