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Submitted by acheadle on Wed, 01/30/2019 - 15:33
h.t2p2
Studies to Treat or Prevent Pediatric Type 2 Diabetes: TODAY2 Phase 2 Follow-up (T2P2)

In this follow-up study to the TODAY clinical trial, T2P2 will evaluate the rates of comorbidities and complications in the TODAY cohort and will compare with rates for children with type 1 diabetes with a similar age of onset and with adult-onset type 2 diabetes.  Two hypotheses will be tested: (1) youth-onset T2D will progress rapidly and result in high rates of diabetes-related medical complications and comorbidities and (2) 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.

 

VISIT STUDY WEBSITE

 

T2P2 on ClinicalTrials.gov

 

TODAY on ClinicalTrials.gov

PRINCIPALINVESTIGATORS

Kimberly Drews, PhD

ADDITIONAL INVESTIGATORS

Barbara H. Braffett, PhD, Diane  Uschner, PhD

RESEARCH STAFF

Brian Burke, Laure El ghormli, Mihili Gunaratne, Jason Stonewall, Bereket Tesfaldet, Melinda Tung, Meghan Turney, Jeff Weir, Shirley Zhou

MAJOR PUBLICATIONS

TODAY Study Group. Treatment options for type 2 diabetes in adolescents and youth: a study of the comparative efficacy of metformin alone or in combination with rosiglitazone or lifestyle intervention in adolescents with type 2 diabetes. Pediatric Diabetes 2007; 8:74-87. PMC2752327

TODAY Study Group. A clinical trial to maintain glycemic control in youth with type 2 diabetes. NEJM 2012; 366:2247-2256. PMC3478667

Gandica R and Zeitler P. Update on youth-onset type 2 diabetes: lessons learned from the Treatment Options for Type 2 Diabetes in Adolescents and Youth clinical trial. Advances in Pediatrics 2016; 63:195-209. PMC4955876

Zeitler P, Hirst K, Copeland KC, El ghormli L, Katz LL, Levitsky LL, Linder B, McGuigan P, White NH, Wilfley D for the TODAY Study Group. HbA1c after a short period of monotherapy with metformin identifies durable glycemic control among adolescents with type 2 diabetes. Diabetes Care 2015; 38:2285–2292. PMC4657618

Klingensmith GJ, Pyle L, Nadeau KJ, Barbour LA, Goland RS, Willi SM, Linder B, White NH for the TODAY Study Group. Pregnancy outcomes in youth with type 2 diabetes: the TODAY study experience. Diabetes Care 2016; 39:122-129. PMC4686849

Project Overview:

TODAY2 is the long term follow-up of the youth from TODAY, to track the progression of type 2 diabetes (T2D) and related comorbidities and complications in the TODAY cohort as they transition to young adulthood.

Major findings/impact of study:

TODAY found that metformin plus rosiglitazone was more effective than metformin alone with metformin plus lifestyle having an intermediate effect resulting in more aggressive treatment in clinical practice

Funding Agency or Sponsor:

F

NIDDK

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