Tuesday, August 9, 2022 8/9/2022

Limited Competition for the Continuation of the clinical Centers for The Environmental Determinants of Diabetes in the Young (TEDDY) Study GERMANY_CLINICAL_CENTER

Award Number: U01DK063836
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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PROJECT SUMMARY/ABSTRACT The Environmental Determinants of Diabetes in the Young (TEDDY) study was initiated in 2003 by six clinical centers in the United States and Europe, including ours, to identify infectious agents, dietary factors, or other environmental exposures that may trigger or protect against the development of islet autoimmunity and type 1 diabetes (T1D). Additional long-term scientific goals include assessment of potential gene-environment interactions affecting development of islet autoimmunity or T1D, gaining insight on triggering mechanisms through detailed multi-omics analyses, and sharing collected specimens with broader scientific community for studies of T1D pathogenesis and prevention. A total of 424,788 newborns were screened by HLA-DR,DQ genotyping to identify children at increased risk for T1D and 8,676 enrolled for quarterly follow-up until age 4 and semi-annually thereafter until age 15. Now, 13 years after enrollment began, 5731 (66%) remain actively engaged in the protocol. Our Germany Clinical Center enrolled 593 TEDDY participants. As of 2/28/18, 56 of those have developed persistent confirmed islet autoantibodies and 31 have been diagnosed with T1D. Detailed analyses of biological samples from the entire cohort, along with even more comprehensive multi- omics analyses in selected individuals, will provide a rich dataset to complement the intensive collection of exposure data and highly efficient ascertainment of islet autoimmunity and T1D endpoints in the entire cohort. Specific aims of this renewal application for this multi-center, prospective cohort study for the next 5 years are: 1. Follow the TEDDY cohort of high-risk children for development of islet autoimmunity, diabetes, celiac disease and autoimmune thyroid disease until 15 years of age; collect biological specimens and epidemiological data according to the study protocol. 2. Characterize genetic, epigenetic, transcriptomic, proteomic and metabolomic determinants of islet autoimmunity and T1D in the study participants. 3. Prospectively assess infectious, dietary and other environmental exposures of study participants as triggers of islet autoimmunity, promotors of progression to T1D, or both. A successful study outcome will provide a dataset unprecedented in depth and breadth, to help elucidate specific exposures and mechanisms serving in the etiology and pathogenesis of islet autoimmunity, T1D, and closely related autoimmune diseases. The results will support the development of new strategies to prevent, delay, or reverse the disease.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	FORSCHERGRUPPE DIABETES E.V.	INGOLSTADTER LANDSTR. 1	OBERSCHLEISSHEIM				DEU	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	15	11/16/2021	NON-COMPETING CONTINUATION	$0


Issue Date FY: 2021 ( Subtotal = $229,180 )
2021	2021	FORSCHERGRUPPE DIABETES E.V.	INGOLSTADTER LANDSTR. 1	OBERSCHLEISSHEIM				DEU	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	15	8/18/2021	NON-COMPETING CONTINUATION	$229,180


Issue Date FY: 2020 ( Subtotal = $261,921 )
2020	2020	FORSCHERGRUPPE DIABETES E.V.	INGOLSTADTER LANDSTR. 1	OBERSCHLEISSHEIM		85764		DEU	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	14	8/7/2020	NON-COMPETING CONTINUATION	$261,921
2020	2020	FORSCHERGRUPPE DIABETES E.V.	INGOLSTADTER LANDSTR. 1	OBERSCHLEISSHEIM		85764		DEU	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	14	8/18/2020	NON-COMPETING CONTINUATION	$0


Issue Date FY: 2019 ( Subtotal = $305,573 )
2019	2019	FORSCHERGRUPPE DIABETES E.V.	INGOLSTADTER LANDSTR. 1	OBERSCHLEISSHEIM		85764		DEU	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	13	9/4/2019	NON-COMPETING CONTINUATION	$305,573


Issue Date FY: 2018 ( Subtotal = $409,250 )
2018	2018	FORSCHERGRUPPE DIABETES E.V.	INGOLSTADTER LANDSTR. 1	OBERSCHLEISSHEIM		85764		DEU	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	12	9/25/2018	COMPETING CONTINUATION	$409,250


Issue Date FY: 2012 ( Subtotal = $321,319 )
2012	2012	DIABETES RESEARCH INSTITUTE	KOELNER PLATZ 1 D-80804	MUNICH				DEU	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	10	6/6/2012	NON-COMPETING CONTINUATION	$321,319


Issue Date FY: 2011 ( Subtotal = $55,922 )
2011	2011	DIABETES RESEARCH INSTITUTE	KOELNER PLATZ 1 D-80804	MUNICH				DEU	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	9	7/1/2011	NON-COMPETING CONTINUATION	$55,922
2011	2010	DIABETES RESEARCH INSTITUTE	KOELNER PLATZ	MUNICH					Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	4/27/2011	NON-COMPETING CONTINUATION	$0


Issue Date FY: 2010 ( Subtotal = $535,561 )
2010	2010	DIABETES RESEARCH INSTITUTE	KOELNER PLATZ 1 D-80804	MUNICH				DEU	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	6/16/2010	NON-COMPETING CONTINUATION	$535,561


Issue Date FY: 2009 ( Subtotal = $519,962 )
2009	2009	DIABETES RESEARCH INSTITUTE	KOELNER PLATZ 1 D-80804	MUNICH				DEU	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	7	6/17/2009	NON-COMPETING CONTINUATION	$519,962


Issue Date FY: 2008 ( Subtotal = $504,817 )
2008	2008	DIABETES RESEARCH INSTITUTE	KOELNER PLATZ	MUNICH					Diabetes, Digestive, and Kidney Diseases Extramural Research	000	6	9/1/2008	COMPETING CONTINUATION	$504,817


Issue Date FY: 2007 ( Subtotal = $462,339 )
2007	2007	DIABETES RESEARCH INSTITUTE	KOELNER PLATZ	MUNICH					Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	3/2/2007	NON-COMPETING CONTINUATION	$462,339


Issue Date FY: 2006 ( Subtotal = $0 )
2006	2006	DIABETES RESEARCH INSTITUTE	KOELNER PLATZ	MUNICH					Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	3/31/2006	NON-COMPETING CONTINUATION	$0


Issue Date FY: 2004 ( Subtotal = $1,000,000 )
2004	2004	DIABETES RESEARCH INSTITUTE	KOELNER PLATZ	MUNICH					Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	12/24/2003	NON-COMPETING CONTINUATION	$1,000,000


Issue Date FY: 2003 ( Subtotal = $1,000,000 )
2003	2003	DIABETES RESEARCH INSTITUTE	KOELNER PLATZ	MUNICH					Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1		NEW	$1,000,000


Grand Total All Awards = $5,605,844

Sum of Action Amount is $5,605,844;

Grand Total = $5,605,844

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Limited Competition for the Continuation of the clinical Centers for The Environmental Determinants of Diabetes in the Young (TEDDY) Study GERMANY_CLINICAL_CENTER

Award Number: U01DK063836

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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