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U-01 CONSORTIUM FOR THE STUDY OF CHRONIC PANCREATITIS,DIABETES AND PANCREATIC CANCER CLINICAL CENTERS

Award Number: U01DK108320
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: 09/28/2015
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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U-01 CONSORTIUM FOR THE STUDY OF CHRONIC PANCREATITIS,DIABETES AND PANCREATIC CANCER CLINICAL CENTERS - The continuation of the CPDPC will require the completion of the acquisition of subjects and biospecimens, and sufficient follow-up to determine clinically relevant outcomes. Future efforts for which the CPDPC was formed include includes biomarker development and validation, drug development or repurposing, and therapeutic trials. Biomarker development and validation is needed for such purposes as early diagnosis (chronic pancreatitis and pancreatic cancer), prognosis, risk stratification and precision therapy. A second clinical need is the development of better therapies for the diabetes associated with pancreatic diseases, and better management of the pancreatic diseases themselves. We propose one biomarker study for the next phase of the CPDPC, a study of sarcopenia as a biomarker for worse outcome in patients with chronic pancreatitis. We also propose 2 potential trials for the next phase of the CPDPC, one focused on developing more effective therapy for pancreaticogenic (Type 3c) diabetes and one for a trial assessing timing of surgical intervention in painful chronic pancreatitis: 1. Finalize recruitment and follow-up of the PROCEED, DETECT, and NOD cohorts, and incorporate strategies to increase recruitment of NOD subjects. Recruitment, retention, and high quality data will need to be continued for all the cohorts. Recruitment into the NOD protocol has been most challenging. We will utilize the OneFlorida clinical data research network to identify partner health organizations within Florida to increase the pool of eligible study subjects in both NOD as well as future clinical trials. 2. Characterize the prevalence, predictors, and impact of sarcopenia in patients with acute relapsing pancreatitis and chronic pancreatitis, and the interaction with coexistent diabetes; and establish strategies to identify and treat sarcopenia in these patients. While sarcopenia has been identified as a common consequence of pancreatic cancer, the prevalence of sarcopenia and clinical impact in patients with chronic pancreatitis is of equal clinical import. 3. Implement a clinical trial within the CPDPC assessing the timing of surgical intervention in patients with painful chronic pancreatitis or relapsing pancreatitis. Pain is the most common symptom from chronic pancreatitis, the most common reason for intervention, and the most important detractor from quality of life. Medical, endoscopic, and surgical therapy are not highly effective, and the choice and timing of intervention for best outcomes is not known. A trial comparing outcomes from surgical therapy (drainage or resection) compared to endoscopic therapy in individuals with suitable anatomy who are not dependent on opioids and have not developed continuous pain is likely to identify more effective timing of therapy. 4. Determine the most effective and safest management strategy for pancreaticogenic diabetes (Type 3c) in patients with chronic pancreatitis. These individuals have a mix of insulin resistance and insulin deficiency, and may be malnourished. The lack of pancreatic islet cell counterregulatory hormones make treatment-induced hypoglycemia a very significant risk, and the coexistence of exocrine pancreatic insufficiency may nutrient absorption less predictable. We propose a cross sectional analysis of patients entered into PROCEED and DETECT cohorts, followed by a trial of two treatment approaches (current standard medical therapy, versus newly available devices for continuous glucose monitoring and insulin therapy) to determine the most effective and safest strategies. This proposed work spans critical areas of knowledge deficit: the role of sarcopenia in chronic pancreatitis and relapsing acute pancreatitis, the most effective use of interventional therapy for chronic pancreatitis pain, and the management of the complex metabolic profiles of Type3c diabetes. These potential projects, if adopted by the continuation of the CPDPC, will a


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: 2026 ( Subtotal = -$158,709 )
2026	2024	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	10	11/26/2025	NON-COMPETING CONTINUATION	-$158,709
														Subtotal = -$158,709

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	10	12/2/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $437,436 )
2024	2024	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	10	7/15/2024	NON-COMPETING CONTINUATION	$437,436
2024	2023	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	9	5/27/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $437,436

Issue Date FY: 2023 ( Subtotal = $590,662 )
2023	2023	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	9	8/2/2023	SUPPLEMENT FOR EXPANSION	$135,000
2023	2023	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	9	7/7/2023	NON-COMPETING CONTINUATION	$455,662
														Subtotal = $590,662

Issue Date FY: 2022 ( Subtotal = $546,062 )
2022	2022	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	8	7/1/2022	NON-COMPETING CONTINUATION	$455,662
2022	2022	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	004	8	8/25/2022	SUPPLEMENT FOR EXPANSION	$90,400
2022	2021	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	7	5/2/2022	NON-COMPETING CONTINUATION	$0
2022	2020	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	6	3/4/2022	COMPETING CONTINUATION	$2,546
2022	2019	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	3/4/2022	SUPPLEMENT FOR EXPANSION	-$2,546
														Subtotal = $546,062

Issue Date FY: 2021 ( Subtotal = $455,662 )
2021	2021	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	7	7/7/2021	NON-COMPETING CONTINUATION	$455,662
2021	2020	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	6	1/29/2021	COMPETING CONTINUATION	$76,568
2021	2020	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	6	7/2/2021	COMPETING CONTINUATION	$0
2021	2019	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	1/29/2021	SUPPLEMENT FOR EXPANSION	-$76,568
														Subtotal = $455,662

Issue Date FY: 2020 ( Subtotal = $546,062 )
2020	2020	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	6	9/2/2020	COMPETING CONTINUATION	$455,662
2020	2020	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	6	9/16/2020	SUPPLEMENT FOR EXPANSION	$90,400
2020	2019	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	5	8/25/2020	NON-COMPETING CONTINUATION	$0
2020	2019	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	5/27/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $546,062

Issue Date FY: 2019 ( Subtotal = $487,695 )
2019	2019	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	5	9/12/2019	SUPPLEMENT FOR EXPANSION	$127,845
2019	2019	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	5	9/9/2019	NON-COMPETING CONTINUATION	$359,850
2019	2018	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	2/4/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $487,695

Issue Date FY: 2018 ( Subtotal = $373,553 )
2018	2018	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	9/10/2018	NON-COMPETING CONTINUATION	$373,553
														Subtotal = $373,553

Issue Date FY: 2017 ( Subtotal = $388,805 )
2017	2017	UNIVERSITY OF FLORIDA	207 GRINTER HALL	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	9/15/2017	NON-COMPETING CONTINUATION	$388,805
														Subtotal = $388,805

Issue Date FY: 2016 ( Subtotal = $382,431 )
2016	2016	UNIVERSITY OF FLORIDA	PO BOX 113001, 302 TIGERT HALL	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	9/13/2016	NON-COMPETING CONTINUATION	$382,431
														Subtotal = $382,431

Issue Date FY: 2015 ( Subtotal = $357,680 )
2015	2015	UNIVERSITY OF FLORIDA	PO BOX 113001, 302 TIGERT HALL	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/25/2015	NEW	$357,680
														Subtotal = $357,680

Grand Total All Awards = $4,407,339

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U-01 CONSORTIUM FOR THE STUDY OF CHRONIC PANCREATITIS,DIABETES AND PANCREATIC CANCER CLINICAL CENTERS

Award Number: U01DK108320

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: 09/28/2015

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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