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TEDDY - The Environmental Determinants of Diabetes in the Young

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: NCT00279318
Recruitment Status : Active, not recruiting
First Posted : January 19, 2006
Last Update Posted : June 9, 2020
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Environmental Health Sciences (NIEHS)
Juvenile Diabetes Research Foundation
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Tracking Information
First Submitted Date January 17, 2006
First Posted Date January 19, 2006
Last Update Posted Date June 9, 2020
Study Start Date September 2004
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 17, 2013)
Appearance of one or more islet cell autoantibodies: GADA, IAA, or IA-2A confirmed at two consecutive visits. [ Time Frame: September 2025 ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: July 17, 2013)
Development of T1DM [ Time Frame: September 2025 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title TEDDY - The Environmental Determinants of Diabetes in the Young
Official Title Consortium for Identification of Environmental Triggers of Type 1 Diabetes
Brief Summary The long-term goal of the TEDDY study is the identification of infectious agents, dietary factors, or other environmental agents, including psychosocial factors which trigger T1DM in genetically susceptible individuals or which protect against the disease. Identification of such factors will lead to a better understanding of disease pathogenesis and result in new strategies to prevent, delay or reverse T1DM.
Detailed Description

Epidemiologic patterns suggest that viruses, nutrition, toxic agents or socioeconomic psychosocial factors may contribute to the etiology alone or in combination. Elucidation is confounded by the long interval between exposure and onset of clinical disease, as well as the interaction of multiple genes and/or insults, which appear to interact in a complex manner. Numerous studies have investigated environmental influences but have yielded conflicting results. This may be in part due to the failure to account for genetic susceptibility, begin observation at early ages or in utero, and/or monitor subjects long term and frequently.

Hypotheses:

  1. Initiation of persistent beta-cell autoimmunity and progression from beta-cell autoimmunity to diabetes is increased with:

    1. Exposure to a trigger factor during pregnancy, such as infections, preeclampsia, blood incompatibility, or birth weight.
    2. Differences in the timing of the introduction and/or the type of dietary constituents that include exposure to cereals or gluten, exposure to cow's milk during infancy and/or childhood, and short duration of breast- feeding;
    3. Lower intake of serum 25 hydroxyvitamin D in early infancy, vitamin E, anti-oxidants (e.g., carotenoids, ascorbic acid, selenium, or omega-3 fatty acids);
    4. Higher frequency of specific (e.g., enterovirus, rotavirus, or bacterial) infections, or non-specific childhood infections including those that exhibit molecular mimicry;
    5. Increased exposure to routine childhood immunizations and their timing;
    6. Environmental factors that may be contained in drinking water (e.g., low concentrations of zinc or high concentrations of nitrates, or lower pH levels);
    7. Exposure to household pets, and various allergies;
    8. Excessive weight gain;
    9. Increased psychological stress.
  2. The risk of persistent beta-cell autoimmunity is lower in children from the general population than in offspring or siblings of T1DM patients when stratifying for the HLA DR-DQ genotype and exposure to environmental triggers.
  3. The interaction of HLA DR-DQ genotype with exposure to dietary or infectious factors leads to increased incidence of beta-cell autoimmunity and T1DM.
  4. We expect that in some families study participation will be associated with affective (anxiety, depression) and behavioral responses (e.g. actions to prevent possible T1DM).
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum, plasma, PBMCs, stool, urine, saliva, nasal swabs, nail clippings, water, teeth
Sampling Method Non-Probability Sample
Study Population Childen up to 4 months of age with specified HLA are enrolled and followed longitudnally until 15 years of age
Condition Type 1 Diabetes Mellitus
Intervention Not Provided
Study Groups/Cohorts General Population, First Degree Relative
Newborns with high risk HLA in the general population or having a first-degree relative affected with T1DM.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: February 1, 2011)
8668
Original Enrollment
 (submitted: January 17, 2006)
7092
Estimated Study Completion Date September 2025
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Newborns with high risk HLA in the general population or having a first- degree relative affected with T1DM
  • Newborns are less than 4 months of age

Exclusion Criteria:

  • Have an illness or birth defect that precludes long-term follow-up or involves use of treatment that may alter the natural history of diabetes (e.g. steroids or insulin)
  • Refuses to have blood and stool samples stored at the NIDDK Repository
Sex/Gender
Sexes Eligible for Study: All
Ages up to 4 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Finland,   Germany,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00279318
Other Study ID Numbers DK095300; DK100238; DK106955
1UC4DK095300-01 ( U.S. NIH Grant/Contract )
1UC4DK100238-01 ( U.S. NIH Grant/Contract )
1UC4DK106955-01 ( U.S. NIH Grant/Contract )
1UC4DK112243-01 ( U.S. NIH Grant/Contract )
1UC4DK117483-01 ( U.S. NIH Grant/Contract )
1U01DK124166-01 ( 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: Data are available at the NIDDK Central Repository https://repository.niddk.nih.gov/studies/teddy/?query=teddy
URL: https://repository.niddk.nih.gov/studies/teddy/?query=teddy
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 Institute of Allergy and Infectious Diseases (NIAID)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Environmental Health Sciences (NIEHS)
  • Juvenile Diabetes Research Foundation
  • Centers for Disease Control and Prevention
Investigators
Principal Investigator: Jeffrey P. Krischer, PhD University of South Florida
Principal Investigator: Marian J. Rewers, MD, PhD University of Colorado Health Science Center
Principal Investigator: William A. Hagopian, MD, PhD Pacific Northwest Research Institute
Principal Investigator: Ake Lernmark, MD, PhD Lund University
Principal Investigator: Jorma Toppari, MD, PhD University of Turku
Principal Investigator: Jin-Xiong She, PhD Augusta University Research Institute, Inc.
Principal Investigator: Anette G. Ziegler, MD Diabetes Research Institute
Study Director: Beena Akolkar, PhD National Institutes of Diabetes and Digestive Kidney Diseases
PRS Account National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date June 2020