TODAY2 Phase 2 Follow-up
- Conditions
- Type 2 Diabetes
- Registration Number
- NCT02310724
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 517
- Participated in TODAY clinical trial.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overt diabetic nephropathy every 12 months a microvascular complication determined by glomerular filtration rate \< 70 mL/min/1.73m2
cardiac function year 2 a macrovascular (cardiovascular) risk indicator determined by echocardiogram
microalbuminuria every 12 months a microvascular complication determined by urine albumin excretion \>= 30 mg/day
cardiovascular risk lipid values every 12 months a macrovascular (cardiovascular) risk indicator determined by abnormal lipid value for LDL (\>= 130 mg/dL) or triglycerides (\>= 300 mg/dL)
diabetic retinopathy year 4 a microvascular complication determined by fundus photography
peripheral diabetic neuropathy every 12 months 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.
arterial stiffness year 5 a macrovascular (cardiovascular) risk indicator determined by pulse wave velocity
- Secondary Outcome Measures
Name Time Method glycemic control every 12 months determined by HbA1c (annual)
insulin sensitivity and beta cell function participant years 6 and 9 from baseline 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)
healthcare usage every 6 months determined by participant self report about visits, referrals, treatments, tests, and procedures related to healthcare
psychological disorder every 12 months 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
body composition every 12 months determined by body mass index (BMI) computed from physical measurements of height and weight
eating disorder every 12 months determined by score on participant self report questionnaire Eating Disorder Diagnostic Scale (EDDS)
health-related quality of life every 12 months 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)
life stress every 12 months determined by participant self report questionnaire based on the Yeaworth Adolescent Life Change Event Scale
blood pressure every 12 months determined by collection of blood pressure
sleep function years 2-3 determined by scores on standard questionnaires and in-lab polysomnogram
Trial Locations
- Locations (15)
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
University of Colorado Denver Children's Hospital
🇺🇸Aurora, Colorado, United States
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
🇺🇸Saint Louis, Missouri, United States
Washington University
🇺🇸Saint 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
Scroll for more (5 remaining)Children's Hospital Los Angeles🇺🇸Los Angeles, California, United States