- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01364350
TODAY2 Phase 1 Immediate Post-Intervention Observational Follow-up Study (T2P1)
TODAY2 Phase 1 Immediate Post-Intervention Observational Follow-up Study of the TODAY Clinical Trial Cohort
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) was a multi-center study of the optimal approach to treatment of type 2 diabetes (T2D) in children and adolescents. The TODAY clinical trial of experimental interventions ended in February 2011. It is followed by TODAY2, a longitudinal study to continue the care and observation of the TODAY cohort beyond the end of the TODAY intervention trial. TODAY2 consists of two phases.
- First is the immediate transition of TODAY participants to non-blinded, non-randomized standard diabetes care and management with monitoring and follow-up for up to 24 months. During this period, the findings of TODAY are analyzed and interpreted by the study group.
- The second phase is a protocol for long-term longitudinal follow-up of the TODAY cohort, based on findings from TODAY.
The primary objective of the first phase of TODAY2 is to continue to follow the TODAY subjects for up to 24 months in order to begin to:
- understand the persistence of the effects of the different treatment regimens used in TODAY,
- describe the continued evolution of beta cell function, and
- describe the development of vascular complications and risk factors for complications.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90027
- Children's Hospital Los Angeles
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Colorado
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Denver, Colorado, United States, 80262
- University of Colorado Denver
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Connecticut
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New Haven, Connecticut, United States, 06519
- Yale University
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Maryland
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Rockville, Maryland, United States, 20852
- George Washington University Biostatistics Center
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Joslin Diabetes Center
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital Diabetes Center
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University
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Saint Louis, Missouri, United States, 63104
- Saint Louis University
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Syracuse, New York, United States, 13214
- State University of New York Upstate Medical University
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Ohio
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Cleveland, Ohio, United States, 44106
- Case Western Reserve University
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73117
- University of Oklahoma Health Sciences Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, United States, 15213
- Children's Hospital of Pittsburgh
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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San Antonio, Texas, United States, 78229
- University of Texas Health Science Center at San Antonio
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participated in the TODAY clinical trial.
- Provided informed consent to participate in T2P1.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
TODAY cohort
The cohort of participants diagnosed with type 2 diabetes ages 10 to <18 and obese at time of diagnosis who participated in the TODAY clinical trial are recruited, consented and followed.
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Participants consenting to receive study-provided care may be treated with metformin, insulin, statin, and ace-inhibitor, as needed for glycemic control and for comorbid conditions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
effects of TODAY treatment assignment on long-term glycemic control
Time Frame: observed for 2 years in phase 1
|
The primary objective of the first phase of TODAY2 is to begin to examine the persistence of effects of the TODAY treatment assignment on long-term glycemic control following discontinuation of randomized treatment.
During this period, results of TODAY are produced and used to define additional outcomes for the second phase of TODAY2.
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observed for 2 years in phase 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
glycemic control
Time Frame: observed for 2 years in phase 1
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HbA1c is the designated measure of glycemic control during T2P1.
Mean HbA1c levels for participants from the three original TODAY treatment arms are compared as measures of the degree and durability of glycemic control after discontinuation of initial randomized therapy.
The overall target is to maintain HbA1c levels as close to the normal range as possible in order to reduce long-term diabetes complications.
TODAY2 continues to use HbA1c < 6% as the target.
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observed for 2 years in phase 1
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safety
Time Frame: observed for 2 years in phase 1
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In TODAY2, subjects are treated with approved medications, i.e., metformin and/or insulin.
No specific abnormalities are expected to develop in this cohort, given the well-documented safety record of these agents.
However, abnormalities in laboratory tests (hemoglobin/hematocrit, liver function tests, calculated creatinine clearance), episodes of severe hypoglycemia, and incidence of side effects (e.g., gastrointestinal complaints) are tracked.
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observed for 2 years in phase 1
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insulin sensitivity and secretion
Time Frame: observed for 2 years in phase 1
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An important component of TODAY2 is to continue to monitor insulin sensitivity and secretion in the TODAY cohort after discontinuation of randomized therapy to determine (1) the evolution of changes in insulin secretion and sensitivity as participants emerge from puberty and enter young adulthood and (2) the effect of each of the initial therapies on the progression of changes in insulin sensitivity and secretion. Insulin sensitivity and secretion are determined with fasting glucose, insulin, C-peptide, and proinsulin levels, OGTT-based indices, HOMA, and QUICKI measured annually. |
observed for 2 years in phase 1
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cardiovascular risk factors
Time Frame: observed for 2 years in phase 1
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Both traditional and non-traditional CVD risk factors are measured in the first phase of TODAY2 and assessed overall as well as compared across initial treatment arms.
Blood pressure is measured at every visit and specimens drawn annually for repeated measurements of lipids (free fatty acids, lipoprotein subclass levels, average LDL particle density, and total apoB level), fibrinogen, c-reactive protein, plasminogen activator inhibitor-1, homocysteine (vitamin B-12 to evaluate homocysteine levels), and interleukin-6.
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observed for 2 years in phase 1
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microvascular complications
Time Frame: observed for 2 years in phase 1
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Quantitation of microalbuminuria is performed by obtaining spot urine measurements of microalbumin/creatinine ratio at annual visits. Abnormal values are confirmed with two additional samples within three months; diagnosis of microalbuminuria is made as a result of two out of three positive tests. Creatinine clearance (by calculation) is determined at annual visits. The presence of peripheral neuropathy is evaluated using the Michigan Neuropathy Screening Instrument (MNSI) performed annually. |
observed for 2 years in phase 1
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sonia Caprio, MD, Yale University
- Principal Investigator: Silva Arslanian, MD, University of Pittsburgh
- Principal Investigator: Leona Cuttler, MD, CWRU Rainbow Babies and Children's Hospital
- Principal Investigator: Ken Copeland, MD, University of Oklahoma Health Science Center
- Principal Investigator: Mitch Geffner, MD, Children's Hospital Los Angeles
- Principal Investigator: Robin Goland, MD, Columbia University Naomi Berrie Diabetes Center
- Principal Investigator: Lorraine Katz, MD, Children's Hospital of Philadelphia
- Principal Investigator: Lori Laffel, MD, Joslin Diabetes Center
- Study Director: Barbara Linder, MD PhD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Principal Investigator: Jane Lynch, MD, The University of Texas Health Science Center at San Antonio
- Principal Investigator: Siripoom McKay, MD, Baylor College of Medicine
- Principal Investigator: David Nathan, MD, Massachusetts General Hospital
- Principal Investigator: Sherida Tollefsen, MD, Saint Louis University Health Sciences Center
- Principal Investigator: Ruth Weinstock, MD PhD, State University of New York - Upstate Medical University
- Principal Investigator: Neil White, MD, Washington University School of Medicine
- Study Chair: Phil Zeitler, MD PhD, University of Colorado, Denver
- Principal Investigator: Kathryn Hirst, PhD, George Washington University
Publications and helpful links
General Publications
- TODAY Study Group. Postintervention Effects of Varying Treatment Arms on Glycemic Failure and beta-Cell Function in the TODAY Trial. Diabetes Care. 2021 Jan;44(1):75-80. doi: 10.2337/dc20-0622. Epub 2020 Nov 10.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK61230-T2P1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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