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Trial record 2 of 75 for:    TODAY Type 2

TODAY2 Phase 2 Follow-up (T2P2)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT02310724
First received: June 18, 2014
Last updated: March 29, 2016
Last verified: March 2016
  Purpose

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.

Condition Intervention
Type 2 Diabetes
Other: TODAY cohort

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Post-Intervention Follow-up of the TODAY Cohort (Treatment Options for Type 2 Diabetes in Youth and Adolescents)

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • diabetic retinopathy [ Time Frame: year 4 ] [ Designated as safety issue: No ]
    a microvascular complication determined by fundus photography

  • microalbuminuria [ Time Frame: every 12 months ] [ Designated as safety issue: No ]
    a microvascular complication determined by urine albumin excretion >= 30 mg/day

  • overt diabetic nephropathy [ Time Frame: every 12 months ] [ Designated as safety issue: No ]
    a microvascular complication determined by glomerular filtration rate < 70 mL/min/1.73m2

  • peripheral diabetic neuropathy [ Time Frame: every 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    a macrovascular (cardiovascular) risk indicator determined by echocardiogram

  • arterial stiffness [ Time Frame: year 5 ] [ Designated as safety issue: No ]
    a macrovascular (cardiovascular) risk indicator determined by pulse wave velocity

  • cardiovascular risk lipid values [ Time Frame: every 12 months ] [ Designated as safety issue: No ]
    a macrovascular (cardiovascular) risk indicator determined by abnormal lipid value for LDL (>= 130 mg/dL) or triglycerides (>= 300 mg/dL)


Secondary Outcome Measures:
  • glycemic control [ Time Frame: every 12 months ] [ Designated as safety issue: No ]
    determined by HbA1c (annual)

  • psychological disorder [ Time Frame: every 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    determined by score on participant self report questionnaire Eating Disorder Diagnostic Scale (EDDS)

  • health-related quality of life [ Time Frame: every 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    determined by collection of blood pressure

  • sleep function [ Time Frame: years 2-3 ] [ Designated as safety issue: No ]
    determined by scores on standard questionnaires and in-lab polysomnogram

  • life stress [ Time Frame: every 12 months ] [ Designated as safety issue: No ]
    determined by participant self report questionnaire based on the Yeaworth Adolescent Life Change Event Scale

  • healthcare usage [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
    determined by participant self report about visits, referrals, treatments, tests, and procedures related to healthcare


Biospecimen Retention:   Samples Without DNA
Blood and urine are collected annually and shipped to the study's Central Biospecimen Laboratory for analysis and storage.

Estimated Enrollment: 506
Study Start Date: March 2014
Estimated Study Completion Date: February 2021
Estimated Primary Completion Date: February 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: TODAY cohort
This protocol is observation only and involves no intervention, care, treatment, or management.

  Eligibility

Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Participated in TODAY clinical trial.

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02310724

Locations
United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
United States, Colorado
University of Colorado Denver Children's Hospital
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University School of Medicine Department of Pediatrics
New Haven, Connecticut, United States, 06520
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
United States, Missouri
Saint Louis University
St Louis, Missouri, United States, 63104
Washington University
St Louis, Missouri, United States, 63110
United States, New York
Columbia University Naomi Berrie Diabetes Center
New York, New York, United States, 10032
SUNY Upstate New York University
Syracuse, New York, United States, 13210
United States, Ohio
Case Western Reserve University Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Oklahoma
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas Health Sciences Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Chair: Philip S Zeitler, MD PhD University of Colorado Denver Children's Hospital
Principal Investigator: Silva Arslanian, MD Children's Hospital of Pittsburgh
Principal Investigator: Sonia Caprio, MD Yale University
Principal Investigator: Kenneth C Copeland, 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
  More Information

Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT02310724     History of Changes
Other Study ID Numbers: DK61230-T2P2 
Study First Received: June 18, 2014
Last Updated: March 29, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
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.

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
youth onset type 2 diabetes
insulin sensitivity
beta cell function
macrovascular comorbidities
microvascular comorbidities

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on December 07, 2016