TODAY2 Phase 2 Follow-up

Study Overview
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Brief Summary
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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.

Official Title
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Long-term Post-Intervention Follow-up of the TODAY Cohort (Treatment Options for Type 2 Diabetes in Youth and Adolescents)

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: TODAY cohort


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participated in TODAY clinical trial. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TODAY cohort<br>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. | Other: TODAY cohort<br>* This protocol is observation only and involves no intervention, care, treatment, or management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycemic control | determined by HbA1c (annual) | every 12 months | 
| psychological disorder | determined by scores on the following participant self-report standard surveys: (a) the Beck Depression Inventory II (BDI-II), (b) the Patient Health Questionnaire (PHQ) scales for somatic symptoms, anxiety, and alcohol use; participants are also interviewed about emotional or mental health problems involving referral, treatment, or hospitalization, and psychiatric diagnoses made by a non-study source that can be confirmed according to standard study criteria from acquired medical records are also recorded | every 12 months | 
| body composition | determined by body mass index (BMI) computed from physical measurements of height and weight | every 12 months | 
| insulin sensitivity and beta cell function | determined by oral glucose tolerance test (at 6 and 9 years from randomization) to derive measures of insulin sensitivity (1/insulin0), insulin secretion (ΔC-peptide30-0/Δglucose30-0, Δinsulin30-0/Δglucose30-0 if not on insulin), and the oral disposition index (oDI = insulin sensitivity x insulin secretion) | participant years 6 and 9 from baseline | 
| eating disorder | determined by score on participant self report questionnaire Eating Disorder Diagnostic Scale (EDDS) | every 12 months | 
| health-related quality of life | determined by score on the participant self report questionnaire Pediatric Quality of Life Inventory version 4.0 with age-specific versions for teen (13-18), young adult (19-25), and adult (≥26) | every 12 months | 
| blood pressure | determined by collection of blood pressure | every 12 months | 
| sleep function | determined by scores on standard questionnaires and in-lab polysomnogram | years 2-3 | 
| life stress | determined by participant self report questionnaire based on the Yeaworth Adolescent Life Change Event Scale | every 12 months | 
| healthcare usage | determined by participant self report about visits, referrals, treatments, tests, and procedures related to healthcare | every 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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youth onset type 2 diabetes, insulin sensitivity, beta cell function, macrovascular comorbidities, microvascular comorbidities