The Environmental Determinants of Diabetes in the Young
Number of Subjects in Study Archive: Screened: 424,788. Enrolled: 8677
Study Design: Cohort
Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 1
Duration: Screening phase: 2004-02/2010. Enrollment ended 06/2010. Follow up phases: 2004-2024.
# Recruitment Centers: 6
Treatment: None, observational only
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Clinical Trials URL: http://www.clinicaltrials.gov/show/NCT00279318
The Environmental Determinants of Diabetes in the Young (TEDDY) study is an observational cohort study investigating genetic and genetic-environmental interactions, including gestational infection or other gestational events, childhood infections or other environmental factors after birth, in relation to the development of prediabetic autoimmunity and Type I Diabetes Mellitus (T1DM). Data are being gathered from cohorts of newborns from the general population and newborn first-degree relatives of probands with T1DM. Newborns were first identified to be at genetic risk for T1DM before long term follow-up. These cohorts are to be followed for 15 years for the appearance of various beta-cell autoantibodies and diabetes, with documentation of early childhood diet, reported and measured infections, vaccinations, and psychosocial stressors. The TEDDY data currently available includes the screening phase data, baseline phase data, and an analysis dataset regarding the Sternery HLA manuscript.
To investigate genetic and genetic-environmental interactions, including gestational infection or other gestational events, childhood infections or other environmental factors after birth, in relation to the development of prediabetic autoimmunity and Type I Diabetes. Enrolled subjects are followed for 15 years.
prediabetic autoimmunity, Type 1 Diabetes
Screening phase: two subgroups were created-neonates from the general population (GP), and neonates with first degree relatives with type 1 diabetes (FDR). Enrollment phase: Eligible subjects in the two subpopulations were identified by testing positive for selected haplogenotypes. Infants with an FDR had to test positive for any of nine haplogenotypes (DR3/4, DR4/4, DR4/8, DR3/3,DR4/4b, DR4/1, DR4/13, DR4/9, and DR3/9) for broad HLA diversity. Infants in the GP had to test positive for any of the first four haplogenotypes, with DRB1*0403 as an exclusion allele. In the archived screening dataset, the variable
Screening resulted in an eligibility rate of 4.8% in the general population and 22.3% in infants with first degree relatives with Type 1 diabetes. A total of 21,589 persons screened eligible for the study. Of those, 8677 were enrolled.