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TODAY Genetics Study

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
Overall Status
Completed
CT.gov ID
NCT00722397
Collaborator
(none)
2,654
Enrollment
25
Locations
78
Duration (Months)
106.2
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The TODAY study group has prepared a protocol with the primary objective of collecting blood and phenotypic information to be used to explore relationships between candidate genes and type 2 diabetes (T2D), as well as obesity, insulin resistance, and cardiovascular complications of insulin resistance. Participation in the genetics study includes a blood draw for analysis of diabetes type and DNA extraction, as well as collection of basic family and medical history. Appropriate informed consent and assent are obtained from all participants to extract DNA and send blood, genetic material, and medical history to the Central Repository of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH). The data are kept indefinitely by the Central Repository. The NIDDK will issue requests for proposals (RFP) throughout the scientific community for research that may help in the development of new diagnostic tests, new treatments, and new ways to prevent diabetes and other related comorbidities.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2654 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Genetics Study
    Study Start Date :
    Aug 1, 2008
    Actual Primary Completion Date :
    Feb 1, 2015
    Actual Study Completion Date :
    Feb 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Blood draw to be processed and analyzed to yield genetic data. [Blood is drawn at the single study visit.]

      Blood is sent to the DNA processing center identified by NIDDK for processing and shipment to the NIDDK Repository.

    Secondary Outcome Measures

    1. Phenotype data. [Collected at single study visit.]

      Demographic, medical history, and other data about participant and family, by self-report.

    2. Laboratory values. [Single study visit.]

      Serum glucose, C-peptide, and pancreatic autoimmunity antibodies determined by study central laboratory.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diabetes by ADA criteria (laboratory determinations of fasting glucose ≥ 126 mg/dL, random glucose ≥ 200 mg/dL, or two-hour oral glucose tolerance test (OGTT) glucose ≥ 200 mg/dL) documented and confirmed in medical record or a laboratory determination of HbA1c ≥ 7%. For asymptomatic patients diagnosed with diabetes with a normal fasting glucose but an elevated two-hour glucose during an OGTT, the HbA1c must be ≥ 6%.

    • BMI ≥ 85th percentile documented at time of diagnosis or at screening.

    • Age < 18 at time of diagnosis.

    • Signed informed consent and assent forms as appropriate.

    Exclusion Criteria:

    • Genetic syndrome or disorder known to affect glucose tolerance other than diabetes.

    • Patient on medication known to affect glucose tolerance, insulin sensitivity or secretion within 60 days of the time of diagnosis. If diagnosis is confirmed after the patient has been off the medication for 60 days, the patient may be included. Exclusionary medications include but are not limited to

    1. inhaled steroids at dose above 1000 mcg daily fluticasone equivalent,

    2. oral glucocorticoids,

    3. antirejection or chemotherapy agents (e.g., tacrolimus, L-asparaginase),

    4. atypical antipsychotics.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UAMS Arkansas Children's Hospital Little Rock Arkansas United States 72202
    2 Childrens Hospital Los Angeles Los Angeles California United States 90027
    3 UCSD Rady Children's Hospital San Diego California United States 92123
    4 University of Colorado Denver Aurora Colorado United States 80045
    5 Connecticut Children's Medical Center Hartford Connecticut United States 06106
    6 Yale University New Haven Connecticut United States 06519
    7 University of Florida Gainesville Florida United States 32611
    8 Emory University Atlanta Georgia United States 30322
    9 Indiana University School of Medicine Indianapolis Indiana United States 46202
    10 George Washington University Biostatistics Center Rockville Maryland United States 20852
    11 Massachusetts General Hospital Boston Massachusetts United States 02114
    12 Joslin Diabetes Center Boston Massachusetts United States 02215
    13 Kansas City Children's Mercy Hospital Kansas City Missouri United States 64108
    14 St Louis University Saint Louis Missouri United States 63104
    15 Washington University Saint Louis Missouri United States 63110
    16 Columbia University New York New York United States 10032
    17 State University of New York Upstate Medical University Syracuse New York United States 13214
    18 Case Western Reserve University Cleveland Ohio United States 44106
    19 University of Oklahoma Oklahoma City Oklahoma United States 73117
    20 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    21 Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15213
    22 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    23 Baylor College of Medicine Houston Texas United States 77030
    24 Texas Tech University Health Science Center Lubbock Texas United States 79430
    25 University of Texas Health Science Center San Antonio Texas United States 78207

    Sponsors and Collaborators

    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Investigators

    • Principal Investigator: Phil Zeitler, MD PhD, University of Colorado, Denver
    • Principal Investigator: Kathryn Hirst, PhD, George Washington University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    ClinicalTrials.gov Identifier:
    NCT00722397
    Other Study ID Numbers:
    • IND - DK61230-GENETICS
    • DK61230
    First Posted:
    Jul 25, 2008
    Last Update Posted:
    Aug 4, 2021
    Last Verified:
    Jul 1, 2021
    Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    genetics, pediatrics
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Aug 4, 2021