Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
517 participants
OBSERVATIONAL
2014-03-01
2020-01-17
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TODAY cohort
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.
TODAY cohort
This protocol is observation only and involves no intervention, care, treatment, or management.
Interventions
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TODAY cohort
This protocol is observation only and involves no intervention, care, treatment, or management.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
15 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Eye Institute (NEI)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Principal Investigators
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Philip S Zeitler, MD PhD
Role: STUDY_CHAIR
University of Colorado Denver Children's Hospital
Silva Arslanian, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Sonia Caprio, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Jeanie B Tryggestad, MD
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma Health Science Center
Mitchell E Geffner, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Los Angeles
Robin S Goland, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University Naomi Berrie Diabetes Center
Lorraine L Katz, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Lori MB Laffel, MD
Role: PRINCIPAL_INVESTIGATOR
Joslin Diabetes Center
Jane L Lynch, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Health Sciences Center at San Antonio
Siripoom V McKay, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Rose Gubitosi-Klug, MD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University Rainbow Babies and Children's Hospital
David M Nathan, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Sherida E Tollefsen, MD
Role: PRINCIPAL_INVESTIGATOR
St. Louis University
Ruth S Weinstock, MD PhD
Role: PRINCIPAL_INVESTIGATOR
SUNY Upstate Medical Center
Neil H White, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
University of Colorado Denver Children's Hospital
Aurora, Colorado, United States
Yale University School of Medicine Department of Pediatrics
New Haven, Connecticut, United States
Massachusetts General Hospital
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 Naomi Berrie Diabetes Center
New York, New York, United States
SUNY Upstate New York University
Syracuse, New York, United States
Case Western Reserve University Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
University of Oklahoma Health Science 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 Sciences Center
San Antonio, Texas, United States
Countries
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References
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TODAY Study Group. Health Care Coverage and Glycemic Control in Young Adults With Youth-Onset Type 2 Diabetes: Results From the TODAY2 Study. Diabetes Care. 2020 Oct;43(10):2469-2477. doi: 10.2337/dc20-0760. Epub 2020 Aug 10.
TODAY Study Group. Longitudinal Changes in Cardiac Structure and Function From Adolescence to Young Adulthood in Participants With Type 2 Diabetes Mellitus: The TODAY Follow-Up Study. Circ Heart Fail. 2020 Jun;13(6):e006685. doi: 10.1161/CIRCHEARTFAILURE.119.006685. Epub 2020 Jun 5.
Tryggestad JB, Drews KL, Mele L, Arslanian S, Chernausek SD, Escaname EN, Geffner M, Isganaitis E, Sprague J, Kelsey MM; TODAY Study Group. Impact of youth onset type 2 diabetes during pregnancy on microvascular and cardiac outcomes. Diabetes Res Clin Pract. 2023 Sep;203:110876. doi: 10.1016/j.diabres.2023.110876. Epub 2023 Aug 16.
TODAY Study Group; Shah RD, Braffett BH, Tryggestad JB, Hughan KS, Dhaliwal R, Nadeau KJ, Levitt Katz LE, Gidding SS. Cardiovascular risk factor progression in adolescents and young adults with youth-onset type 2 diabetes. J Diabetes Complications. 2022 Mar;36(3):108123. doi: 10.1016/j.jdiacomp.2021.108123. Epub 2022 Jan 3.
Trief PM, Uschner D, Tung M, Marcus MD, Rayas M, MacLeish S, Farrell R, Keady J, Chao L, Weinstock RS. Diabetes Distress in Young Adults With Youth-Onset Type 2 Diabetes: TODAY2 Study Results. Diabetes Care. 2022 Mar 1;45(3):529-537. doi: 10.2337/dc21-1689.
TODAY Study Group; Bjornstad P, Drews KL, Caprio S, Gubitosi-Klug R, Nathan DM, Tesfaldet B, Tryggestad J, White NH, Zeitler P. Long-Term Complications in Youth-Onset Type 2 Diabetes. N Engl J Med. 2021 Jul 29;385(5):416-426. doi: 10.1056/NEJMoa2100165.
Other Identifiers
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DK61230-T2P2
Identifier Type: -
Identifier Source: org_study_id
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