Clinical trial NCT01364350: TODAY2 Phase 1 Immediate Post-Intervention Observational Follow-up Study
Official title: TODAY2 Phase 1 Immediate Post-Intervention Observational Follow-up Study of the TODAY Clinical Trial Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus Type 2 in Obese
Keywords: type 2 diabetes mellitus
pediatrics
post-intervention study
metformin
complications
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2011-06-02
Enrollment: 550
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participants in the TODAY clinical trial

Brief summary: 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.

Detailed description: TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) was a multi-center study of the optimal approach to treatment of type 2 diabetes (T2D) in children and adolescents. The TODAY clinical trial of experimental interventions ended in February 2011. It is followed by TODAY2, a longitudinal study to continue the care and observation of the TODAY cohort beyond the end of the TODAY intervention trial. TODAY2 consists of two phases.

1. First is the immediate transition of TODAY participants to non-blinded, non-randomized standard diabetes care and management with monitoring and follow-up for up to 24 months. During this period, the findings of TODAY are analyzed and interpreted by the study group.
2. The second phase is a protocol for long-term longitudinal follow-up of the TODAY cohort, based on findings from TODAY.

The primary objective of the first phase of TODAY2 is to continue to follow the TODAY subjects for up to 24 months in order to begin to:

* understand the persistence of the effects of the different treatment regimens used in TODAY,
* describe the continued evolution of beta cell function, and
* describe the development of vascular complications and risk factors for complications.

Eligibility criteria: Inclusion Criteria:

* Participated in the TODAY clinical trial.
* Provided informed consent to participate in T2P1.

Primary outcomes:
measure: effects of TODAY treatment assignment on long-term glycemic control
timeFrame: observed for 2 years in phase 1
Secondary outcomes:
measure: glycemic control
timeFrame: observed for 2 years in phase 1
measure: safety
timeFrame: observed for 2 years in phase 1
measure: insulin sensitivity and secretion
timeFrame: observed for 2 years in phase 1
measure: cardiovascular risk factors
timeFrame: observed for 2 years in phase 1
measure: microvascular complications
timeFrame: observed for 2 years in phase 1
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Rockville
country: United States
facility: George Washington University Biostatistics Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital Diabetes Center
state: Massachusetts
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Syracuse
country: United States
facility: State University of New York Upstate Medical University
state: New York
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Pittsburgh
name: Silva Arslanian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Sonia Caprio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CWRU Rainbow Babies and Children's Hospital
name: Leona Cuttler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma Health Science Center
name: Ken Copeland, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Los Angeles
name: Mitch Geffner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University Naomi Berrie Diabetes Center
name: Robin Goland, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Lorraine Katz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Joslin Diabetes Center
name: Lori Laffel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Barbara Linder, MD PhD
role: STUDY_DIRECTOR
affiliation: The University of Texas Health Science Center at San Antonio
name: Jane Lynch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Siripoom McKay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: David Nathan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Louis University Health Sciences Center
name: Sherida Tollefsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of New York - Upstate Medical University
name: Ruth Weinstock, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Neil White, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Phil Zeitler, MD PhD
role: STUDY_CHAIR
affiliation: George Washington University
name: Kathryn Hirst, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.