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The Saint Louis University Component of the NASH Clinical Research Network

Award Number: U01DK061718
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/20/2002
PERIOD OF PERFORMANCE END DATE: 06/30/2027

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The Saint Louis University Component of the NASH Clinical Research Network - Abstract This application is for the renewal of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) clinical center at Saint Louis University and its pediatric component at Baylor University. The NASH Clinical Research Network (NASH CRN) has been sponsored by the NIDDK since 2002 with renewals in 2009, 2014 and 2019. Metabolic dysfunction associated steatotic liver disease (MASLD, previously called NAFLD) affects more than one out of three adults and one out of five children the U.S. MASLD, and especially its most severe subset, metabolic dysfunction associated steatohepatitis (MASH, previously called NASH), may lead to cirrhosis and primary liver cancer resulting in death or liver transplant which contributes to substantial health burdens and costs. The NASH CRN has been ideally and uniquely positioned to impact the growing public health significance of MASH that can only be addressed via a large research consortium. A primary objective of the NASH CRN has been to perform clinical trials of therapeutic agents for MASH in adults and children. A closely linked and high priority secondary objective is to conduct translational research in MASH and MASLD focusing on the pathogenesis that will provide the basis for understanding the natural history and developing better means of diagnosis, prevention, treatment, and clinical management. In this final phase of the NASH CRN, the adult vitamin E dosing trial (VEDS) initiated during the previous funding cycle will be completed. The longitudinal cohort Database-3 study of adults and children with MASLD will be wrapped up with closeout visits in year 1 to provide a unique repository of data and samples from a well-phenotyped cohort that can be used in future studies to prospectively define the natural history of the disease, the cardiovascular and metabolic risk factors, aid in biomarker discovery and validation to identify patients with at-risk MASH (MASH and at least stage 2 fibrosis) and identify factors affecting disease progression. The Saint Louis University Clinical Center of the NASH CRN will work collaboratively with the other clinical centers, SDCC and NIDDK to prioritize and conduct studies of existing datasets over the final three years of funding. Proposed in this application is a project for consideration that focuses on the role of the PNPLA3 I148M variant in sequestering and inactivating a protein called ABHD5 or CGI58. Human variants of this protein are associated with progressive liver disease and suppressed expression of this protein in rodents causes steatohepatitis. The underlying hypothesis is that basis for the PNPLA3 I148M variant contributing to progressive liver disease is its role of ABHD5/CGI-58 sequestration rather than its putative role in lipid droplet triglyceride turnover. Whether this project is pursued or other projects are given higher priority, the Saint Louis University clinical center will fully support the decision of the steering committee with input from the NIDDK and devote its resources to the chosen projects. The NASH CRN has had a major impact on the field and directly advances the mission of the National Institutes of Health to improve the health of the public.


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: 2025 ( Subtotal = $0 )
2025	2024	SAINT LOUIS UNIVERSITY	221 N GRAND BLVD	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	23	3/5/2025	COMPETING CONTINUATION	$120,945
2025	2023	SAINT LOUIS UNIVERSITY	221 N GRAND BLVD	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	22	3/5/2025	NON-COMPETING CONTINUATION	-$120,945
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $250,001 )
2024	2024	SAINT LOUIS UNIVERSITY	221 N GRAND BLVD	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	23	8/13/2024	COMPETING CONTINUATION	$250,001
														Subtotal = $250,001

Issue Date FY: 2023 ( Subtotal = $581,470 )
2023	2023	SAINT LOUIS UNIVERSITY	221 N GRAND BLVD	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	22	8/18/2023	NON-COMPETING CONTINUATION	$581,470
														Subtotal = $581,470

Issue Date FY: 2022 ( Subtotal = $478,252 )
2022	2022	SAINT LOUIS UNIVERSITY	221 N GRAND BLVD	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	21	7/15/2022	NON-COMPETING CONTINUATION	$478,252
														Subtotal = $478,252

Issue Date FY: 2021 ( Subtotal = $575,680 )
2021	2021	SAINT LOUIS UNIVERSITY	ONE NORTH GRAND	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	20	7/15/2021	NON-COMPETING CONTINUATION	$575,680
														Subtotal = $575,680

Issue Date FY: 2020 ( Subtotal = $567,695 )
2020	2020	SAINT LOUIS UNIVERSITY	ONE NORTH GRAND	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	19	8/17/2020	NON-COMPETING CONTINUATION	$567,695
2020	2019	SAINT LOUIS UNIVERSITY	ONE NORTH GRAND	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	18	2/20/2020	COMPETING CONTINUATION	$87,706
2020	2018	SAINT LOUIS UNIVERSITY	ONE NORTH GRAND	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	17	2/19/2020	NON-COMPETING CONTINUATION	-$87,706
														Subtotal = $567,695

Issue Date FY: 2019 ( Subtotal = $476,607 )
2019	2019	SAINT LOUIS UNIVERSITY	ONE NORTH GRAND	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	18	9/16/2019	COMPETING CONTINUATION	$476,607
2019	2018	SAINT LOUIS UNIVERSITY	ONE NORTH GRAND	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	17	9/16/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $476,607

Issue Date FY: 2018 ( Subtotal = $499,784 )
2018	2018	SAINT LOUIS UNIVERSITY	ONE NORTH GRAND	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	17	7/18/2018	NON-COMPETING CONTINUATION	$499,784
														Subtotal = $499,784

Issue Date FY: 2017 ( Subtotal = $426,708 )
2017	2017	SAINT LOUIS UNIVERSITY	ONE NORTH GRAND	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	16	8/18/2017	NON-COMPETING CONTINUATION	$426,708
														Subtotal = $426,708

Issue Date FY: 2016 ( Subtotal = $465,925 )
2016	2016	SAINT LOUIS UNIVERSITY	3500 LINDELL BLVD/FITZG'D HALL	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	15	7/29/2016	NON-COMPETING CONTINUATION	$465,925
														Subtotal = $465,925

Issue Date FY: 2015 ( Subtotal = $613,687 )
2015	2015	SAINT LOUIS UNIVERSITY	3500 LINDELL BLVD/FITZG'D HALL	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	14	7/1/2015	NON-COMPETING CONTINUATION	$509,198
2015	2015	SAINT LOUIS UNIVERSITY	3500 LINDELL BLVD/FITZG'D HALL	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	13	2/5/2015	SUPPLEMENT FOR EXPANSION	$104,489
														Subtotal = $613,687

Issue Date FY: 2014 ( Subtotal = $452,020 )
2014	2014	SAINT LOUIS UNIVERSITY	3500 LINDELL BLVD/FITZG'D HALL	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	13	7/24/2014	COMPETING CONTINUATION	$452,020
2014	2013	SAINT LOUIS UNIVERSITY	3500 LINDELL BLVD/FITZG'D HALL	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	12	7/21/2014	SUPPLEMENT FOR EXPANSION	$0
2014	2013	SAINT LOUIS UNIVERSITY	3500 LINDELL BLVD/FITZG'D HALL	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	12	7/21/2014	NON-COMPETING CONTINUATION	$0
2014	2013	SAINT LOUIS UNIVERSITY	3500 LINDELL BLVD/FITZG'D HALL	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	12	7/21/2014	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $452,020

Issue Date FY: 2013 ( Subtotal = $810,205 )
2013	2013	SAINT LOUIS UNIVERSITY	3500 LINDELL BLVD/FITZG'D HALL	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	12	8/27/2013	NON-COMPETING CONTINUATION	$350,890
2013	2013	SAINT LOUIS UNIVERSITY	3500 LINDELL BLVD/FITZG'D HALL	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	11	2/5/2013	SUPPLEMENT FOR EXPANSION	$38,975
2013	2013	SAINT LOUIS UNIVERSITY	3500 LINDELL BLVD/FITZG'D HALL	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	004	12	9/13/2013	SUPPLEMENT FOR EXPANSION	$60,217
2013	2013	SAINT LOUIS UNIVERSITY	3500 LINDELL BLVD/FITZG'D HALL	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	12	9/12/2013	SUPPLEMENT FOR EXPANSION	$331,928
2013	2013	SAINT LOUIS UNIVERSITY	3500 LINDELL BLVD/FITZG'D HALL	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	11	2/5/2013	SUPPLEMENT FOR EXPANSION	$28,195
														Subtotal = $810,205

Issue Date FY: 2012 ( Subtotal = $494,413 )
2012	2012	SAINT LOUIS UNIVERSITY	3500 LINDELL BLVD/FITZG'D HALL	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	11	7/27/2012	NON-COMPETING CONTINUATION	$494,413
														Subtotal = $494,413

Issue Date FY: 2011 ( Subtotal = $313,273 )
2011	2011	SAINT LOUIS UNIVERSITY	3500 LINDELL BLVD/FITZG'D HALL	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	10	7/14/2011	NON-COMPETING CONTINUATION	$313,273
2011	2010	SAINT LOUIS UNIVERSITY	3500 LINDELL BLVD/FITZG'D HALL	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Trans-NIH Recovery Act Research Support	000	8	12/21/2010	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $313,273

Issue Date FY: 2010 ( Subtotal = $620,210 )
2010	2010	SAINT LOUIS UNIVERSITY	3500 LINDELL BLVD/FITZG'D HALL	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	9	7/8/2010	NON-COMPETING CONTINUATION	$471,172
2010	2010	SAINT LOUIS UNIVERSITY	3500 LINDELL BLVD/FITZG'D HALL	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Trans-NIH Recovery Act Research Support	000	8	1/25/2010	SUPPLEMENT FOR EXPANSION	$149,038
2010	2009	SAINT LOUIS UNIVERSITY	3500 LINDELL BLVD/FITZG'D HALL	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	8	4/14/2010	COMPETING CONTINUATION	$0
														Subtotal = $620,210

Issue Date FY: 2009 ( Subtotal = $994,440 ) (Continued on the next page)
2009	2009	SAINT LOUIS UNIVERSITY	3500 LINDELL BLVD/FITZG'D HALL	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	004	8	8/10/2009	COMPETING CONTINUATION	$735,898
2009	2008	SAINT LOUIS UNIVERSITY	3500 LINDELL BLVD/FITZG'D HALL	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Digestive Diseases and Nutrition Research	001	7	7/8/2009	NON-COMPETING CONTINUATION	$0
Grand Total All Awards = $11,035,734

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The Saint Louis University Component of the NASH Clinical Research Network

Award Number: U01DK061718

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 05/20/2002

PERIOD OF PERFORMANCE END DATE: 06/30/2027

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