Type 2 Diabetes
Conditions
Keywords
youth onset type 2 diabetes, insulin sensitivity, beta cell function, macrovascular comorbidities, microvascular comorbidities
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.
Interventions
OTHERTODAY cohort
This protocol is observation only and involves no intervention, care, treatment, or management.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
National Eye Institute (NEI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participated in TODAY clinical trial.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diabetic retinopathy | year 4 | a microvascular complication determined by fundus photography |
| microalbuminuria | every 12 months | a microvascular complication determined by urine albumin excretion \>= 30 mg/day |
| overt diabetic nephropathy | every 12 months | a microvascular complication determined by glomerular filtration rate \< 70 mL/min/1.73m2 |
| 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. |
| cardiac function | year 2 | a macrovascular (cardiovascular) risk indicator determined by echocardiogram |
| arterial stiffness | year 5 | a macrovascular (cardiovascular) risk indicator determined by pulse wave velocity |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sleep function | years 2-3 | determined by scores on standard questionnaires and in-lab polysomnogram |
| glycemic control | every 12 months | determined by HbA1c (annual) |
| healthcare usage | every 6 months | determined by participant self report about visits, referrals, treatments, tests, and procedures related to healthcare |
| life stress | every 12 months | determined by participant self report questionnaire based on the Yeaworth Adolescent Life Change Event Scale |
| 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 |
| 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) |
| 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) |
| blood pressure | every 12 months | determined by collection of blood pressure |
Countries
United States
Outcome results
None listed