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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 : August 22, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Type 1 Diabetes Mellitus

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.


  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 Design

Study Type : Observational
Actual Enrollment : 8668 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Consortium for Identification of Environmental Triggers of Type 1 Diabetes
Study Start Date : September 2004
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Groups and Cohorts

General Population, First Degree Relative
Newborns with high risk HLA in the general population or having a first-degree relative affected with T1DM.

Outcome Measures

Primary Outcome Measures :
  1. Appearance of one or more islet cell autoantibodies: GADA, IAA, or IA-2A confirmed at two consecutive visits. [ Time Frame: September 2025 ]

Secondary Outcome Measures :
  1. Development of T1DM [ Time Frame: September 2025 ]

Biospecimen Retention:   Samples With DNA
Serum, plasma, PBMCs, stool, urine, saliva, nasal swabs, nail clippings, water

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279318

United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, Florida
Augusta University
Gainesville, Florida, United States, 32608
United States, Georgia
Augusta University
Atlanta, Georgia, United States, 30342
Augusta University
Augusta, Georgia, United States, 30912
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC (this site is only screening babies whose mother, father or full sibiling have type 1 diabetes)
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
Pacific Northwest Diabetes Research Institute
Seattle, Washington, United States, 98122
Turku University Central Hospital
Turku, Finland, 20520
Diabetes Research Institute
Munich, Germany, 80804
Lund University
Malmo, Sweden, 20502
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
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 Diabetes 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
Principal Investigator: Anette G. Ziegler, MD Diabetes Research Institute
Principal Investigator: Beena Akolkar, PhD National Institutes of Diabetes and Digestive Kidney Diseases
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00279318     History of Changes
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 )
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Infectious Agents

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases