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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK061230 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Eye Institute (NEI) | NIH |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TODAY cohort | All 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TODAY cohort | Other | This protocol is observation only and involves no intervention, care, treatment, or management. |
|
| Measure | Description | Time Frame |
|---|---|---|
| diabetic retinopathy | a microvascular complication determined by fundus photography | year 4 |
| microalbuminuria | a microvascular complication determined by urine albumin excretion >= 30 mg/day | every 12 months |
| overt diabetic nephropathy | a microvascular complication determined by glomerular filtration rate < 70 mL/min/1.73m2 | 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. | every 12 months |
| cardiac function | a macrovascular (cardiovascular) risk indicator determined by echocardiogram | year 2 |
| arterial stiffness | a macrovascular (cardiovascular) risk indicator determined by pulse wave velocity | 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) | every 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| glycemic control | determined by HbA1c (annual) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Philip S Zeitler, MD PhD | University of Colorado Denver Children's Hospital | Study Chair |
| Silva Arslanian, MD | University of Pittsburgh | Principal Investigator |
| Sonia Caprio, MD | Yale University | Principal Investigator |
| Jeanie B Tryggestad, MD | University of Oklahoma Health Science Center | Principal Investigator |
| Mitchell E Geffner, MD | Children's Hospital Los Angeles | Principal Investigator |
| Robin S Goland, MD | Columbia University Naomi Berrie Diabetes Center | Principal Investigator |
| Lorraine L Katz, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Lori MB Laffel, MD | Joslin Diabetes Center | Principal Investigator |
| Jane L Lynch, MD | University of Texas Health Sciences Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| University of Colorado Denver Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32778555 | Result | 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. | |
| 32498621 | Result | 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. |
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The TODAY/TODAY2 Study Group engages in a number of methods to disseminate and share resources.
Data will be prepared and provided to the NIDDK Data Repository in early 2022
Currently with approval of the Ancillary Studies Committee and after 2022 as determined by the NIDDK Data Repository
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Blood and urine are collected annually and shipped to the study's Central Biospecimen Laboratory for analysis and storage.
| every 12 months |
| body composition | determined by body mass index (BMI) computed from physical measurements of height and weight | 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) | participant years 6 and 9 from baseline |
| eating disorder | determined by score on participant self report questionnaire Eating Disorder Diagnostic Scale (EDDS) | 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) | every 12 months |
| blood pressure | determined by collection of blood pressure | every 12 months |
| sleep function | determined by scores on standard questionnaires and in-lab polysomnogram | years 2-3 |
| life stress | determined by participant self report questionnaire based on the Yeaworth Adolescent Life Change Event Scale | every 12 months |
| healthcare usage | determined by participant self report about visits, referrals, treatments, tests, and procedures related to healthcare | every 6 months |
| Siripoom V McKay, MD | Baylor College of Medicine | Principal Investigator |
| Rose Gubitosi-Klug, MD | Case Western Reserve University Rainbow Babies and Children's Hospital | Principal Investigator |
| David M Nathan, MD | Massachusetts General Hospital | Principal Investigator |
| Sherida E Tollefsen, MD | St. Louis University | Principal Investigator |
| Ruth S Weinstock, MD PhD | SUNY Upstate Medical Center | Principal Investigator |
| Neil H White, MD | Washington University School of Medicine | Principal Investigator |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Yale University School of Medicine Department of Pediatrics | New Haven | Connecticut | 06520 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| Saint Louis University | St Louis | Missouri | 63104 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Columbia University Naomi Berrie Diabetes Center | New York | New York | 10032 | United States |
| SUNY Upstate New York University | Syracuse | New York | 13210 | United States |
| Case Western Reserve University Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | United States |
| University of Oklahoma Health Science Center | Oklahoma City | Oklahoma | 73104 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Texas Health Sciences Center | San Antonio | Texas | 78229 | United States |
| 37595843 | Derived | 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. |
| 35123868 | Derived | 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. |
| 35015056 | Derived | 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. |
| 34320286 | Derived | 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. |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |