Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00279318
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-07
First Post:
2006-01-17
Brief Title:
TEDDY - The Environmental Determinants of Diabetes in the Young
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Consortium for Identification of Environmental Triggers of Type 1 Diabetes
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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 andor monitor subjects long term and frequently
Hypotheses
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 andor the type of dietary constituents that include exposure to cereals or gluten exposure to cows milk during infancy andor childhood and short duration of breast- feeding
3 Lower intake of serum 25 hydroxyvitamin D in early infancy vitamin E anti-oxidants eg carotenoids ascorbic acid selenium or omega-3 fatty acids
4 Higher frequency of specific eg 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 eg 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 eg actions to prevent possible T1DM
Hypotheses
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 andor the type of dietary constituents that include exposure to cereals or gluten exposure to cows milk during infancy andor childhood and short duration of breast- feeding
3 Lower intake of serum 25 hydroxyvitamin D in early infancy vitamin E anti-oxidants eg carotenoids ascorbic acid selenium or omega-3 fatty acids
4 Higher frequency of specific eg 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 eg 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 eg actions to prevent possible T1DM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1UC4DK095300-01 | NIH | None | None |
| 1UC4DK100238-01 | NIH | None | None |
| 1UC4DK106955-01 | NIH | None | None |
| 1UC4DK112243-01 | NIH | None | None |
| 1UC4DK117483-01 | NIH | None | None |
| 1U01DK124166-01 | NIH | None | None |
| 1U01DK128847-01 | NIH | None | httpsreporternihgovquickSearch1U01DK128847-01 |