Clinical trial NCT02310724: TODAY2 Phase 2 Follow-up
Official title: Long-term Post-Intervention Follow-up of the TODAY Cohort (Treatment Options for Type 2 Diabetes in Youth and Adolescents)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: youth onset type 2 diabetes
insulin sensitivity
beta cell function
macrovascular comorbidities
microvascular comorbidities
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Eye Institute (NEI)
First posted: 2014-12-08
Enrollment: 517
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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:

* 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.


Eligibility criteria: Inclusion Criteria:

* Participated in TODAY clinical trial.

Exclusion Criteria:

-

Primary outcomes:
measure: diabetic retinopathy
timeFrame: year 4
measure: microalbuminuria
timeFrame: every 12 months
measure: overt diabetic nephropathy
timeFrame: every 12 months
measure: peripheral diabetic neuropathy
timeFrame: every 12 months
measure: cardiac function
timeFrame: year 2
measure: arterial stiffness
timeFrame: year 5
measure: cardiovascular risk lipid values
timeFrame: every 12 months
Secondary outcomes:
measure: glycemic control
timeFrame: every 12 months
measure: psychological disorder
timeFrame: every 12 months
measure: body composition
timeFrame: every 12 months
measure: insulin sensitivity and beta cell function
timeFrame: participant years 6 and 9 from baseline
measure: eating disorder
timeFrame: every 12 months
measure: health-related quality of life
timeFrame: every 12 months
measure: blood pressure
timeFrame: every 12 months
measure: sleep function
timeFrame: years 2-3
measure: life stress
timeFrame: every 12 months
measure: healthcare usage
timeFrame: every 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Aurora
country: United States
facility: University of Colorado Denver Children's Hospital
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine Department of Pediatrics
state: Connecticut
city: Boston
country: United States
facility: Massachusetts General Hospital
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 Naomi Berrie Diabetes Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate New York University
state: New York
city: Cleveland
country: United States
facility: Case Western Reserve University Rainbow Babies and Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science 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 Sciences Center
state: Texas
Study officials:
affiliation: University of Colorado Denver Children's Hospital
name: Philip S Zeitler, MD PhD
role: STUDY_CHAIR
affiliation: University of Pittsburgh
name: Silva Arslanian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Sonia Caprio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma Health Science Center
name: Jeanie B Tryggestad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Los Angeles
name: Mitchell E Geffner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University Naomi Berrie Diabetes Center
name: Robin S Goland, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Lorraine L Katz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Joslin Diabetes Center
name: Lori MB Laffel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Health Sciences Center at San Antonio
name: Jane L Lynch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Siripoom V McKay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University Rainbow Babies and Children's Hospital
name: Rose Gubitosi-Klug, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: David M Nathan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Louis University
name: Sherida E Tollefsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SUNY Upstate Medical Center
name: Ruth S Weinstock, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Neil H White, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.