NCT01364350|CompletedDMC
TODAY2 Phase 1 Immediate Post-Intervention Observational Follow-up Study
T2P1
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T2P1
Sponsor study identifier
observational
550
1 country
16
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2014
Actual (reported)Study Completion
February 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
May 24, 2011
Actual (reported)June 2, 2011
Actual (reported)February 2014
Actual (reported)February 2014
Actual (reported)effects of TODAY treatment assignment on long-term glycemic control
The primary objective of the first phase of TODAY2 is to begin to examine the persistence of effects of the TODAY treatment assignment on long-term glycemic control following discontinuation of randomized treatment. During this period, results of TODAY are produced and used to define additional outcomes for the second phase of TODAY2.
observed for 2 years in phase 1
glycemic control
observed for 2 years in phase 1
safety
observed for 2 years in phase 1
insulin sensitivity and secretion
observed for 2 years in phase 1
cardiovascular risk factors
observed for 2 years in phase 1
microvascular complications
observed for 2 years in phase 1
The cohort of participants diagnosed with type 2 diabetes ages 10 to \<18 and obese at time of diagnosis who participated in the TODAY clinical trial are recruited, consented and followed.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
participants in the TODAY clinical trial
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
University of Colorado Denver
Denver, Colorado, 80262, United States
Yale University
New Haven, Connecticut, 06519, United States
George Washington University Biostatistics Center
Rockville, Maryland, 20852, United States
Massachusetts General Hospital Diabetes Center
Boston, Massachusetts, 02114, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Saint Louis University
St Louis, Missouri, 63104, United States
TODAY Study Group. Postintervention Effects of Varying Treatment Arms on Glycemic Failure and beta-Cell Function in the TODAY Trial. Diabetes Care. 2021 Jan;44(1):75-80. doi: 10.2337/dc20-0622. Epub 2020 Nov 10.
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.
Blood and urine are collected on an annual basis and sent to the Central Biospecimen Laboratory for analysis and storage. Analyses performed on an annual basis are: HbA1c, insulin sensitivity and secreation (fasting glucose, insulin, C-peptide, and proinsulin), 2-hour OGTT, pancreatic autoimmunity, serum creatinine, liver function tests, lipids (LDL, triglycerides, free fatty acids, lipoprotein subclass levels, average LDL particle density, and total apoB levels), cardiovascular risk factors (fibrinogen, c-reactive protein, homocysteine vitamin B-12, plasminogran activator inhibitor-1, interleukin-6), microalbumin. HbA1c is also analyzed quarterly.
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
550 participants (actual enrollment reported by the registry).
First Submitted
May 24, 2011
First Posted
June 2, 2011
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Efficacy of SASI Bypass for Type-2 Diabetic Obese Patients
Contact the study team to confirm eligibility.
Washington University
St Louis, Missouri, 63110, United States
Columbia University Medical Center
New York, New York, 10032, United States
State University of New York Upstate Medical University
Syracuse, New York, 13214, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73117, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
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.
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
Primary Completion
February 2014
Actual (reported)Study Completion
February 2014
Actual (reported)Last Updated
August 4, 2021
Record last verified: 2021-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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