The Environmental Determinants of Diabetes in the Young  (TEDDY)

A cohort of children with elevated genetic risk for type 1 diabetes will be established by screening newborns from the general population and from families with first-degree relatives diagnosed with type 1 diabetes.

The primary objective(s) of this multi-center, multi-national, epidemiological study will be identification of infectious agents, dietary factors, or other environmental exposures that are associated with increased risk of autoimmunity and type 1 diabetes. Factors affecting specific phenotypic manifestations such as early age of onset or rate of progression, or with protection for the development of type 1 diabetes will also be identified.

The TEDDY study will recruit and enroll individuals, including obtaining informed consent from parents prior to or shortly after birth, obtain genetic and other samples from neonates and parents, and prospectively follow selected neonates throughout childhood or until development of islet autoimmunity or type 1 diabetes. The clinical center will collect and transmit genetic and other samples and familial and clinical data as delineated in the manual of operation to the Data Coordinating Center.

A cohort of children with elevated genetic risk for type 1 diabetes will be established by screening newborns from the general population and from families with first-degree relatives diagnosed with the disease.

Results from previous studies on the environmental determinants of type 1 diabetes have been confounded by imprecise assessment of exposure, recall bias, failure to account for genetic susceptibility, failure to assess exposures at very early ages, or the inability to follow a sufficient sample of children long-term with high intensity. The present multi-center study will provide an opportunity to fill important gaps in our understanding of the events leading to the development of type 1 diabetes by studying from birth high-risk general population children and relatives and by systematic screening of candidate environmental and genetic factors. We will apply "cutting edge" molecular immunologic and genetic techniques to samples collected in six cohorts of high-risk children. In addition, samples collected by TEDDY will create a valuable resource for investigators proposing innovative hypotheses concerning candidate environmental and genetic factors.

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 type 1 diabetes 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 type 1 diabetes.

Participants of the TEDDY study will be followed with a clinic visit every three months. At each clinic visit, the participants will be interviewed. Medical information pertaining to possible environmental exposure will be obtained by interview or questionnaires at each of the clinical visits. An assessment of the maternal diet will take place at the first interview. Assessment of the infant抯 food consumption and dietary habits will be assessed by questionnaire, structured interview at each clinic visit. The duration of total and exclusive breastfeeding, age at introduction of various foods during the first 2 years of life, type of infant formulas used, source of drinking water (local waterworks, bottled water, private wells), elimination diets, and use of dietary supplements will be recorded. A 3-day food diary of the child抯 dietary intake at 3 month intervals during the first year of life and biannually thereafter will also be required of study participants.

Blood samples will be obtained at each visit. These will include samples for autoantibodies (proteins produced by the immune system, which signify that there is some damage to the insulin producing cells of the pancreas), markers of inflammation, antibodies to viruses and potentially other infectious agents, vitamins and other potential toxin and other environmental exposures. In addition, blood will be drawn for mRNA analyses which enable us to study any potential genes that may change over time and that may help us understand the process that eventually leads to the development of diabetes. In addition, blood will be drawn for storage so as to enable future measurement of possible causative agents or other substances that will enable us to understand the process leading to type 1 diabetes. No more than 10-15 cc of blood will be drawn at each visit.

Stool samples will be collected at monthly intervals to assess viral exposures. Parents will be required to collect the stool sample at home using containers provided by the clinical center. The stool samples will then have to be shipped to the study laboratory.

Other samples that will be collected from study participants include toenail clippings and tap water samples. The psychological impact of study participation will also be assessed.

An oral glucose tolerance test (OGTT) will be performed every six months on every child who has tested positive for two or more autoantibodies at any previous visit and is three years of age or older.

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