Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY)
Public ClinicalTrials.gov record NCT00081328. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Clinical Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00081328
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 699 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 10 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2004
- Primary completion
- Jan 31, 2011
- Completion
- Jan 31, 2014
- Last update posted
- Jul 29, 2021
2004 – 2014
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| University of Colorado Health Sciences Center, The Children's Hospital | Denver | Colorado | 80262 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| George Washington University Biostatistics Center | Rockville | Maryland | 20852 | — |
| Massachusetts General Hospital Diabetes Center | Boston | Massachusetts | 02114 | — |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | — |
| Saint Louis University Health Sciences Center | St Louis | Missouri | 63104 | — |
| Washington University Department of Pediatrics | St Louis | Missouri | 63110 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | — |
| Case Western Reserve | Cleveland | Ohio | 44106 | — |
| University of Oklahoma | Oklahoma City | Oklahoma | 93104 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00081328, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 29, 2021 · Synced Sep 13, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00081328 live on ClinicalTrials.gov.