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.
Study Type
OBSERVATIONAL
Enrollment
517
This protocol is observation only and involves no intervention, care, treatment, or management.
Children's Hospital Los Angeles
Los Angeles, California, United States
University of Colorado Denver Children's Hospital
Aurora, Colorado, United States
diabetic retinopathy
a microvascular complication determined by fundus photography
Time frame: year 4
microalbuminuria
a microvascular complication determined by urine albumin excretion \>= 30 mg/day
Time frame: every 12 months
overt diabetic nephropathy
a microvascular complication determined by glomerular filtration rate \< 70 mL/min/1.73m2
Time frame: 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.
Time frame: every 12 months
cardiac function
a macrovascular (cardiovascular) risk indicator determined by echocardiogram
Time frame: year 2
arterial stiffness
a macrovascular (cardiovascular) risk indicator determined by pulse wave velocity
Time frame: 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)
Time frame: every 12 months
glycemic control
determined by HbA1c (annual)
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Yale University School of Medicine Department of Pediatrics
New Haven, Connecticut, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Saint Louis University
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
Columbia University Naomi Berrie Diabetes Center
New York, New York, United States
SUNY Upstate New York University
Syracuse, New York, United States
Case Western Reserve University Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
...and 5 more locations
Time frame: 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
Time frame: every 12 months
body composition
determined by body mass index (BMI) computed from physical measurements of height and weight
Time frame: 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)
Time frame: participant years 6 and 9 from baseline
eating disorder
determined by score on participant self report questionnaire Eating Disorder Diagnostic Scale (EDDS)
Time frame: 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)
Time frame: every 12 months
blood pressure
determined by collection of blood pressure
Time frame: every 12 months
sleep function
determined by scores on standard questionnaires and in-lab polysomnogram
Time frame: years 2-3
life stress
determined by participant self report questionnaire based on the Yeaworth Adolescent Life Change Event Scale
Time frame: every 12 months
healthcare usage
determined by participant self report about visits, referrals, treatments, tests, and procedures related to healthcare
Time frame: every 6 months