NCT02310724|CompletedDMC
TODAY2 Phase 2 Follow-up
T2P2
Long-term Post-Intervention Follow-up of the TODAY Cohort (Treatment Options for Type 2 Diabetes in Youth and Adolescents)
Loading search results
T2P2
Long-term Post-Intervention Follow-up of the TODAY Cohort (Treatment Options for Type 2 Diabetes in Youth and Adolescents)
Sponsor study identifier
Secondary identifiers
NIH
observational
517
1 country
15
Study Start
March 1, 2014
Actual (reported)Primary Completion
January 17, 2020
Actual (reported)Study Completion
January 17, 2020
Actual (reported)The primary objective of T2P2 is to track the progression of T2D and related comorbidities and complications in the TODAY cohort as they transition to young adulthood. We hypothesize that:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 17, 2020
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 1, 2014
Actual (reported)June 18, 2014
Actual (reported)December 8, 2014
Actual (reported)January 17, 2020
Actual (reported)January 17, 2020
Actual (reported)diabetic retinopathy
a microvascular complication determined by fundus photography
year 4
microalbuminuria
a microvascular complication determined by urine albumin excretion \>= 30 mg/day
every 12 months
overt diabetic nephropathy
a microvascular complication determined by glomerular filtration rate \< 70 mL/min/1.73m2
every 12 months
peripheral diabetic neuropathy
a microvascular complication defined as the presence of Michigan Neuropathy Screening Instrument (MNSI) exam score \>2 and \<8 out of 10 appropriate responses to the Semmes-Weinstein monofilament (SW-MF) in either foot.
every 12 months
cardiac function
a macrovascular (cardiovascular) risk indicator determined by echocardiogram
year 2
glycemic control
every 12 months
psychological disorder
every 12 months
body composition
every 12 months
insulin sensitivity and beta cell function
participant years 6 and 9 from baseline
eating disorder
every 12 months
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.
This protocol is observation only and involves no intervention, care, treatment, or management.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All subjects randomized into the TODAY study are eligible to participate in T2P2. There are no additional inclusion or exclusions criteria for participation in T2P2.
Contact the study team to confirm eligibility.
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
University of Colorado Denver Children's Hospital
Aurora, Colorado, 80045, United States
Yale University School of Medicine Department of Pediatrics
New Haven, Connecticut, 06520, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Saint Louis University
St Louis, Missouri, 63104, United States
Washington University
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.
Blood and urine are collected annually and shipped to the study's Central Biospecimen Laboratory for analysis and storage.
Philip S Zeitler, MD PhD
University of Colorado Denver Children's Hospital
Silva Arslanian, MD
University of Pittsburgh
Sonia Caprio, MD
Yale University
Jeanie B Tryggestad, MD
University of Oklahoma Health Science Center
517 participants (actual enrollment reported by the registry).
First Submitted
June 18, 2014
First Posted
December 8, 2014
Study Start
March 1, 2014
Actual (reported)Title: Therapeutic Targets in African-American Youth With Type 2 Diabetes
arterial stiffness
a macrovascular (cardiovascular) risk indicator determined by pulse wave velocity
year 5
cardiovascular risk lipid values
a macrovascular (cardiovascular) risk indicator determined by abnormal lipid value for LDL (\>= 130 mg/dL) or triglycerides (\>= 300 mg/dL)
every 12 months
St Louis, Missouri, 63110, United States
Columbia University Naomi Berrie Diabetes Center
New York, New York, 10032, United States
SUNY Upstate New York University
Syracuse, New York, 13210, United States
Case Western Reserve University Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Texas Health Sciences Center
San Antonio, Texas, 78229, United States
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.
Mitchell E Geffner, MD
Children's Hospital Los Angeles
Robin S Goland, MD
Columbia University Naomi Berrie Diabetes Center
Lorraine L Katz, MD
Children's Hospital of Philadelphia
Lori MB Laffel, MD
Joslin Diabetes Center
Jane L Lynch, MD
University of Texas Health Sciences Center at San Antonio
Siripoom V McKay, MD
Baylor College of Medicine
Rose Gubitosi-Klug, MD
Case Western Reserve University Rainbow Babies and Children's Hospital
David M Nathan, MD
Massachusetts General Hospital
Sherida E Tollefsen, MD
St. Louis University
Ruth S Weinstock, MD PhD
SUNY Upstate Medical Center
Neil H White, MD
Washington University School of Medicine
Primary Completion
January 17, 2020
Actual (reported)Study Completion
January 17, 2020
Actual (reported)Last Updated
August 5, 2021
Record last verified: 2021-07
The TODAY/TODAY2 Study Group engages in a number of methods to disseminate and share resources. * Findings are reported in manuscripts and presentations. * An active Ancillary Studies Committee reviews proposals to access the study cohort, the central database, and stored biospecimens. * Materials from the TODAY lifestyle intervention program and the standard diabetes education manual for adolescents developed by study experts are made available for public access on the website https://today.bsc.gwu.edu/web/today/home. * The study group adheres to the policies of the NIDDK Central Repositories to make data available to other scientific investigators. A TODAY2 de-identified database will be prepared and transferred along with excess stored biospecimens. Appropriate informed consent is required to transfer stored biospecimens. * TODAY establishes collaborative arrangements to work with other federally funded study groups.
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.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: