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Type 2 DiabetesT2P2NCT02310724

TODAY2 Phase 2 Follow-up

An observational study of Type 2 Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
TODAY cohort
How many people
517 participants
Where
15 sitesUnited States
Study dates
1 Mar 2014to 17 Jan 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All subjects randomized into the TODAY study are eligible to participate in T2P2. There are no additional inclusion or exclusions criteria for participation in T2P2.

Who may be able to join

  • Participated in TODAY clinical trial.

Who cannot join

  • -

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • University of Colorado Denver Children's Hospital

    Aurora, Colorado, 80045

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • Case Western Reserve University Rainbow Babies and Children's Hospital

    Cleveland, Ohio, 44106

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • Yale University School of Medicine Department of Pediatrics

    New Haven, Connecticut, 06520

  • Columbia University Naomi Berrie Diabetes Center

    New York, New York, 10032

  • University of Oklahoma Health Science Center

    Oklahoma City, Oklahoma, 73104

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

  • University of Texas Health Sciences Center

    San Antonio, Texas, 78229

  • Saint Louis University

    St Louis, Missouri, 63104

  • Washington University

    St Louis, Missouri, 63110

  • SUNY Upstate New York University

    Syracuse, New York, 13210

Other trials in United States

About this study

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

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.
Conditions
Type 2 Diabetes
Being tested
TODAY cohort
Keywords
youth onset type 2 diabetes, insulin sensitivity, beta cell function, macrovascular comorbidities, microvascular comorbidities
Medical subject headings
Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TODAY cohortOther

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

Study groups in NCT02310724
Study groupRoleWhat they receive
TODAY cohortAll 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.
Receives: Other: TODAY cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. diabetic retinopathy

    a microvascular complication determined by fundus photography

    Measured: year 4

  2. microalbuminuria

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

    Measured: every 12 months

  3. overt diabetic nephropathy

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

    Measured: every 12 months

  4. 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.

    Measured: every 12 months

  5. cardiac function

    a macrovascular (cardiovascular) risk indicator determined by echocardiogram

    Measured: year 2

  6. arterial stiffness

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

    Measured: year 5

  7. cardiovascular risk lipid values

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

    Measured: every 12 months

Secondary outcomes (10)

  1. glycemic control

    determined by HbA1c (annual)

    Measured: every 12 months

  2. 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

    Measured: every 12 months

  3. body composition

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

    Measured: every 12 months

  4. 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)

    Measured: participant years 6 and 9 from baseline

  5. eating disorder

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

    Measured: every 12 months

  6. 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)

    Measured: every 12 months

  7. blood pressure

    determined by collection of blood pressure

    Measured: every 12 months

  8. sleep function

    determined by scores on standard questionnaires and in-lab polysomnogram

    Measured: years 2-3

  9. life stress

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

    Measured: every 12 months

  10. healthcare usage

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

    Measured: every 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2014 (estimated)
  2. Study start1 Mar 2014
  3. Primary completion17 Jan 2020
  4. Study completion17 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
517 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02310724
Sponsor's protocol ID
DK61230-T2P2
Other IDs
U01DK061230
Acronym
T2P2
Status last verified
Jul 2021
First submitted
18 Jun 2014
Last updated
5 Aug 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: The TODAY/TODAY2 Study Group engages in a number of methods to disseminate and share resources. * Findings are reported in manuscripts and presentations. * An active Ancillary Studies Committee reviews proposals to access the study cohort, the central database, and stored biospecimens. * Materials from the TODAY lifestyle intervention program and the standard diabetes education manual for adolescents developed by study experts are made available for public access on the website https://today.bsc.gwu.edu/web/today/home. * The study group adheres to the policies of the NIDDK Central Repositories to make data available to other scientific investigators. A TODAY2 de-identified database will be prepared and transferred along with excess stored biospecimens. Appropriate informed consent is required to transfer stored biospecimens. * TODAY establishes collaborative arrangements to work with other federally funded study groups.

Publications

  • TODAY Study Group. Health Care Coverage and Glycemic Control in Young Adults With Youth-Onset Type 2 Diabetes: Results From the TODAY2 Study. Diabetes Care. 2020 Oct;43(10):2469-2477. doi: 10.2337/dc20-0760. Epub 2020 Aug 10.

    PubMed 32778555

  • TODAY Study Group. Longitudinal Changes in Cardiac Structure and Function From Adolescence to Young Adulthood in Participants With Type 2 Diabetes Mellitus: The TODAY Follow-Up Study. Circ Heart Fail. 2020 Jun;13(6):e006685. doi: 10.1161/CIRCHEARTFAILURE.119.006685. Epub 2020 Jun 5.

    PubMed 32498621

  • Tryggestad JB, Drews KL, Mele L, Arslanian S, Chernausek SD, Escaname EN, Geffner M, Isganaitis E, Sprague J, Kelsey MM; TODAY Study Group. Impact of youth onset type 2 diabetes during pregnancy on microvascular and cardiac outcomes. Diabetes Res Clin Pract. 2023 Sep;203:110876. doi: 10.1016/j.diabres.2023.110876. Epub 2023 Aug 16.

    PubMed 37595843

  • TODAY Study Group; Shah RD, Braffett BH, Tryggestad JB, Hughan KS, Dhaliwal R, Nadeau KJ, Levitt Katz LE, Gidding SS. Cardiovascular risk factor progression in adolescents and young adults with youth-onset type 2 diabetes. J Diabetes Complications. 2022 Mar;36(3):108123. doi: 10.1016/j.jdiacomp.2021.108123. Epub 2022 Jan 3.

    PubMed 35123868

  • Trief PM, Uschner D, Tung M, Marcus MD, Rayas M, MacLeish S, Farrell R, Keady J, Chao L, Weinstock RS. Diabetes Distress in Young Adults With Youth-Onset Type 2 Diabetes: TODAY2 Study Results. Diabetes Care. 2022 Mar 1;45(3):529-537. doi: 10.2337/dc21-1689.

    PubMed 35015056

  • TODAY Study Group; Bjornstad P, Drews KL, Caprio S, Gubitosi-Klug R, Nathan DM, Tesfaldet B, Tryggestad J, White NH, Zeitler P. Long-Term Complications in Youth-Onset Type 2 Diabetes. N Engl J Med. 2021 Jul 29;385(5):416-426. doi: 10.1056/NEJMoa2100165.

    PubMed 34320286

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

diabetic retinopathy (time frame: year 4). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02310724, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.

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TODAY2 Phase 2 Follow-up (NCT02310724) | AzTrials