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OpenTrials
Completed

NCT Number: NCT02310724

TODAY2 Phase 2 Follow-up

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Los Angeles, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participated in TODAY clinical trial.

Exclusion criteria

-

Treatment and study plan

TODAY cohort

Other

This protocol is observation only and involves no intervention, care, treatment, or management.

Primary outcomes

  1. diabetic retinopathy

    Time frame: year 4

    a microvascular complication determined by fundus photography

  2. microalbuminuria

    Time frame: every 12 months

    a microvascular complication determined by urine albumin excretion >= 30 mg/day

  3. overt diabetic nephropathy

    Time frame: every 12 months

    a microvascular complication determined by glomerular filtration rate < 70 mL/min/1.73m2

  4. peripheral diabetic neuropathy

    Time frame: 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.

  5. cardiac function

    Time frame: year 2

    a macrovascular (cardiovascular) risk indicator determined by echocardiogram

  6. arterial stiffness

    Time frame: year 5

    a macrovascular (cardiovascular) risk indicator determined by pulse wave velocity

  7. cardiovascular risk lipid values

    Time frame: every 12 months

    a macrovascular (cardiovascular) risk indicator determined by abnormal lipid value for LDL (>= 130 mg/dL) or triglycerides (>= 300 mg/dL)

Secondary outcomes

  1. glycemic control

    Time frame: every 12 months

    determined by HbA1c (annual)

  2. psychological disorder

    Time frame: 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

  3. body composition

    Time frame: every 12 months

    determined by body mass index (BMI) computed from physical measurements of height and weight

  4. insulin sensitivity and beta cell function

    Time frame: 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)

  5. eating disorder

    Time frame: every 12 months

    determined by score on participant self report questionnaire Eating Disorder Diagnostic Scale (EDDS)

  6. health-related quality of life

    Time frame: 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)

  7. blood pressure

    Time frame: every 12 months

    determined by collection of blood pressure

  8. sleep function

    Time frame: years 2-3

    determined by scores on standard questionnaires and in-lab polysomnogram

  9. life stress

    Time frame: every 12 months

    determined by participant self report questionnaire based on the Yeaworth Adolescent Life Change Event Scale

  10. healthcare usage

    Time frame: every 6 months

    determined by participant self report about visits, referrals, treatments, tests, and procedures related to healthcare

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Collaborators

  • National Eye Institute (NEI)
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: T2P2

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Dec 8, 2014
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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