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TODAY2 Phase 2 Follow-up (T2P2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310724
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : February 28, 2020
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Eye Institute (NEI)
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Tracking Information
First Submitted Date June 18, 2014
First Posted Date December 8, 2014
Last Update Posted Date February 28, 2020
Actual Study Start Date March 1, 2014
Actual Primary Completion Date January 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 29, 2016)
  • diabetic retinopathy [ Time Frame: year 4 ]
    a microvascular complication determined by fundus photography
  • microalbuminuria [ Time Frame: every 12 months ]
    a microvascular complication determined by urine albumin excretion >= 30 mg/day
  • overt diabetic nephropathy [ Time Frame: every 12 months ]
    a microvascular complication determined by glomerular filtration rate < 70 mL/min/1.73m2
  • 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.
  • cardiac function [ Time Frame: year 2 ]
    a macrovascular (cardiovascular) risk indicator determined by echocardiogram
  • arterial stiffness [ Time Frame: year 5 ]
    a macrovascular (cardiovascular) risk indicator determined by pulse wave velocity
  • 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)
Original Primary Outcome Measures
 (submitted: December 4, 2014)
  • diabetic retinopathy [ Time Frame: year 4 ]
    a microvascular complication determined by fundus photography
  • microalbuminuria [ Time Frame: annual ]
    a microvascular complication determined by urine albumin excretion >= 30 mg/day
  • overt diabetic nephropathy [ Time Frame: annual ]
    a microvascular complication determined by glomerular filtration rate < 70 mL/min/1.73m2
  • peripheral diabetic neuropathy [ Time Frame: annual ]
    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 [ Time Frame: year 2 ]
    a macrovascular (cardiovascular) risk indicator determined by echocardiogram
  • arterial stiffness [ Time Frame: year 5 ]
    a macrovascular (cardiovascular) risk indicator determined by pulse wave velocity
  • cardiovascular risk lipid values [ Time Frame: annual ]
    a macrovascular (cardiovascular) risk indicator determined by abnormal lipid value for LDL (>= 130 mg/dL) or triglycerides (>= 300 mg/dL)
Change History
Current Secondary Outcome Measures
 (submitted: March 29, 2016)
  • glycemic control [ Time Frame: every 12 months ]
    determined by HbA1c (annual)
  • 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
  • body composition [ Time Frame: every 12 months ]
    determined by body mass index (BMI) computed from physical measurements of height and weight
  • 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)
  • eating disorder [ Time Frame: every 12 months ]
    determined by score on participant self report questionnaire Eating Disorder Diagnostic Scale (EDDS)
  • 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)
  • blood pressure [ Time Frame: every 12 months ]
    determined by collection of blood pressure
  • sleep function [ Time Frame: years 2-3 ]
    determined by scores on standard questionnaires and in-lab polysomnogram
  • life stress [ Time Frame: every 12 months ]
    determined by participant self report questionnaire based on the Yeaworth Adolescent Life Change Event Scale
  • healthcare usage [ Time Frame: every 6 months ]
    determined by participant self report about visits, referrals, treatments, tests, and procedures related to healthcare
Original Secondary Outcome Measures
 (submitted: December 4, 2014)
  • glycemic control [ Time Frame: annual ]
    determined by HbA1c (annual)
  • psychological disorder [ Time Frame: annual ]
    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 [ Time Frame: annual ]
    determined by body mass index (BMI) computed from physical measurements of height and weight
  • 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)
  • eating disorder [ Time Frame: annual ]
    determined by score on participant self report questionnaire Eating Disorder Diagnostic Scale (EDDS)
  • health-related quality of life [ Time Frame: annual ]
    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 [ Time Frame: annual ]
    determined by collection of blood pressure
  • sleep function [ Time Frame: years 2-3 ]
    determined by scores on standard questionnaires and in-lab polysomnogram
  • life stress [ Time Frame: annual ]
    determined by participant self report questionnaire based on the Yeaworth Adolescent Life Change Event Scale
  • healthcare usage [ Time Frame: every 6 months ]
    determined by participant self report about visits, referrals, treatments, tests, and procedures related to healthcare
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title TODAY2 Phase 2 Follow-up
Official Title Long-term Post-Intervention Follow-up of the TODAY Cohort (Treatment Options for Type 2 Diabetes in Youth and Adolescents)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood and urine are collected annually and shipped to the study's Central Biospecimen Laboratory for analysis and storage.
Sampling Method Non-Probability Sample
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.
Condition Type 2 Diabetes
Intervention Other: TODAY cohort
This protocol is observation only and involves no intervention, care, treatment, or management.
Study Groups/Cohorts 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.
Intervention: Other: TODAY cohort
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 7, 2019)		 517
Original Estimated Enrollment
 (submitted: December 4, 2014)		 506
Actual Study Completion Date January 17, 2020
Actual Primary Completion Date January 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Participated in TODAY clinical trial.

Exclusion Criteria:

-
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02310724
Other Study ID Numbers DK61230-T2P2
U01DK061230 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description:

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.
Supporting Materials: Study Protocol
Time Frame: Data will be prepared and provided to the NIDDK Data Repository in early 2022
Access Criteria: Currently with approval of the Ancillary Studies Committee and after 2022 as determined by the NIDDK Data Repository
Responsible Party National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Eye Institute (NEI)
Investigators
Study Chair: Philip S Zeitler, MD PhD University of Colorado Denver Children's Hospital
Principal Investigator: 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: 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
PRS Account National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date February 2020