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 26, 2019
|Condition or disease|
|Type 1 Diabetes Mellitus|
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.
Initiation of persistent beta-cell autoimmunity and progression from beta-cell autoimmunity to diabetes is increased with:
- Exposure to a trigger factor during pregnancy, such as infections, preeclampsia, blood incompatibility, or birth weight.
- 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;
- 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);
- Higher frequency of specific (e.g., enterovirus, rotavirus, or bacterial) infections, or non-specific childhood infections including those that exhibit molecular mimicry;
- Increased exposure to routine childhood immunizations and their timing;
- Environmental factors that may be contained in drinking water (e.g., low concentrations of zinc or high concentrations of nitrates, or lower pH levels);
- Exposure to household pets, and various allergies;
- Excessive weight gain;
- Increased psychological stress.
- 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.
- The interaction of HLA DR-DQ genotype with exposure to dietary or infectious factors leads to increased incidence of beta-cell autoimmunity and T1DM.
- 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|
|Actual Enrollment :||8668 participants|
|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|
General Population, First Degree Relative
Newborns with high risk HLA in the general population or having a first-degree relative affected with T1DM.
- Appearance of one or more islet cell autoantibodies: GADA, IAA, or IA-2A confirmed at two consecutive visits. [ Time Frame: September 2025 ]
- Development of T1DM [ Time Frame: September 2025 ]
Biospecimen Retention: Samples With DNA
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|
|Gainesville, Florida, United States, 32608|
|United States, Georgia|
|Atlanta, Georgia, United States, 30342|
|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 Research Institute|
|Seattle, Washington, United States, 98122|
|Turku University Central Hospital|
|Turku, Finland, 20520|
|Diabetes Research Institute|
|Munich, Germany, 80804|
|Malmo, Sweden, 20502|
|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|