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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 |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00279318 |
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 |
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Type 1 Diabetes Mellitus |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Consortium for Identification of Environmental Triggers of Type 1 Diabetes |
Serum, plasma, stool, saliva, nail clippings, water
Estimated Enrollment: | 7801 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | September 2023 |
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:
Initiation of persistent beta-cell autoimmunity and progression from beta-cell autoimmunity to diabetes is increased with:
Ages Eligible for Study: | up to 4 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Childen up to 4 months of age with specified HLA are enrolled and followed longitudnally
Inclusion Criteria:
Exclusion Criteria:
United States, Colorado | |
University of Colorado Health Sciences Center | Recruiting |
Denver, Colorado, United States, 80262 | |
Contact: Judith Baxter, MA 303-315-6857 judy.baxter@uchsc.edu | |
Principal Investigator: Marian Rewers, MD, PhD | |
United States, Florida | |
Medical College of Georgia | Recruiting |
Gainesville, Florida, United States, 32608 | |
Contact: Angie Choate 352-334-0843 choatal@peds.ufl.edu | |
Principal Investigator: Jin-Xiong She, PhD | |
United States, Georgia | |
Medical College of Georgia | Recruiting |
Augusta, Georgia, United States, 30912 | |
Contact: Diane I Hopkins, MS, CCRC 706-721-4161 dhopkins@mcg.edu | |
Principal Investigator: Jin-Xiong She, PhD | |
Medical College of Georgia | Recruiting |
Atlanta, Georgia, United States, 30342 | |
Contact: Leigh Steed, RN,CDE,CCRC 404-252-0844 lsteed@mail.mcg.edu | |
Contact: Kate Silvis, MS, RD, LD 404-252-0844 ksilvis@mail.mcg.edu | |
Principal Investigator: Jin-Xiong She, PhD | |
United States, New York | |
Naomi Berrie Diabetes Center, Columbia University Medical Center (this site is only screening babies whose mother, father or full sibling have type 1 diabetes) | Recruiting |
New York, New York, United States, 10032 | |
Contact: Diana Arnold 212-851-5466 dea2101@columbia.edu | |
Sub-Investigator: Robin Goland, MD | |
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) | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Peggy Franciscus 412-692-5250 margaret.franciscus@chp.edu | |
Sub-Investigator: Dorothy Becker, MD | |
United States, Washington | |
Pacific Northwest Research Institute | Recruiting |
Seattle, Washington, United States, 98122 | |
Contact: William Hagopian, MD, PhD 206-726-1200 wah@u.washington.edu | |
Principal Investigator: William Hagopian, MD, PhD | |
Finland | |
Turku University Central Hospital | Recruiting |
Turku, Finland, 20520 | |
Contact: Olli Simell, MD, PhD 358-2-313 2466 olli.simell@utu.fi | |
Contact: Tuula Simell, MPH, PhD 358-2-313 3427 tuula.simell@utu.fi | |
Principal Investigator: Olli Simell, MD, PhD | |
Germany | |
Diabetes Research Institute | Recruiting |
Munich, Germany, 80804 | |
Contact: Anette G. Ziegler, MD 0049 / 89 / 30 79 31-21 anziegler@lrz.uni-muenchen.de | |
Contact: Christiane Winkler 0049 / 89/ 30 79 31-14 christiane.winkler@lrz.uni-muenchen.de | |
Principal Investigator: Anette G. Ziegler, MD | |
Sweden | |
University of Lund | Recruiting |
Malmo, Sweden, 20502 | |
Contact: Barbro Lernmark, PhD 46 40 332390 barbro.lernmark@med.lu.se | |
Contact: Ake Lernmark, MD, PhD 46 40 336963 ake.lernmark@med.lu.se | |
Principal Investigator: Ake Lernmark, MD, PhD |
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 | University of Washington & University of Lund |
Principal Investigator: | Olli G. Simell, MD, PhD | University of Turku |
Principal Investigator: | Jin-Xiong She, PhD | Medical College of Georgia |
Principal Investigator: | Anette G. Ziegler, MD | University of Miami |
Principal Investigator: | Beena Akolkar, PhD | National Institutes of Diabetes and Digestive Kidney Diseases |
Responsible Party: | University of South Florida ( Dr. Jeffrey Krischer ) |
Study ID Numbers: | DK63790, 5U01DK063790-04 |
Study First Received: | January 17, 2006 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00279318 |
Health Authority: | United States: Federal Government; United States: Institutional Review Board |
Environment Exposures Diet Toxins Psychosocial |
Infectious Agents Bacterial Viral Immunizations Autoantibody |
Autoimmune Diseases Metabolic Diseases Autoantibodies Diabetes Mellitus, Type 1 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Immune System Diseases |