TODAY2 Phase 1 Immediate Post-Intervention Observational Follow-up Study
Condition: Diabetes Mellitus Type 2 in Obese
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

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.
    

Intervention name(s): standard of care in general clinical practice
Intervention type(s): Other
Intervention description(s): 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.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        participants in the TODAY clinical trial
      
Biospecimen description: 
      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.
    
Keywords: type 2 diabetes mellitus; pediatrics; post-intervention study; metformin; complications