Thursday, November 21, 2024 11/21/2024

20/22 Limited Competition for the Continuation of the Diabetes Prevention Program Outcomes Study (DPPOS) – Clinical Center

Award Number: U01DK048349
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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Abnormal regulation of glycemia (“dysglycemia”) has a very long time course, from the earliest stage of pre-diabetes, to the onset of Type 2 diabetes (T2D), to the development of clinically detectable microvascular changes and measurable atherosclerosis, to clinically manifest complications with attendant morbidity and mortality. The Diabetes Prevention Program (DPP) focused on the pre-diabetes stage of dysglycemia and demonstrated powerful beneficial effects of lifestyle intervention (ILS) and metformin (MET), compared with placebo (PLBO), in preventing or delaying the onset of T2D over a 3-year period in a high-risk population (n=3234). The DPP also investigated and described the interventions, phenotypic and genotypic risk factors associated with T2D development, the effects of the interventions in the setting of these risk factors, the health economic implications of T2D prevention, and other outcomes of interest. Based on these results, the DPP lifestyle program has been widely implemented. The DPP Outcomes Study (DPPOS) has explored the longer-term effects of T2D prevention in the DPP cohort, bridging the period between pre-diabetes and T2D, and has examined outcomes that required more time to develop than the 3-years of DPP. DPPOS showed longer-term salutary effects of the original interventions on T2D prevention and on cardiovascular disease (CVD) risk factors. The risk for microvascular disease was significantly greater in subjects who developed T2D and increased with longer duration and higher hemoglobin A1c (HbA1c). There were no significant differences by treatment group in the prevalence of the aggregate microvascular outcome; however, compared with PLBO and MET, ILS significantly reduced the risk of microvascular disease among women and those with HbA1c ≥6.5%. During the one-year extension of DPPOS Phase 3, we will maintain and continue to follow the well-characterized and valuable DPPOS cohort, and collect measurements of outcomes as described in the protocol. We will 1) perform new analyses to characterize the heterogeneous course of dysglycemia and its long-term complications and factors that define susceptibility or resistance to diabetes, its complications, and common chronic conditions of aging, and 2) explore the factors associated with participant retention, adherence to the protocol and completion of measurements, and determine if alternative methods can be implemented to improve retention and adherence and to expand data collection. These aims will provide important insights into prediabetes and diabetes and their long-term outcomes and could serve the potential further study of the DPPOS cohort.


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: 2024 ( Subtotal = -$26 )
2024	2021	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	30	10/25/2023	COMPETING CONTINUATION	-$26
														Subtotal = -$26

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	30	1/27/2022	COMPETING CONTINUATION	$0
2022	2021	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	30	6/10/2022	COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $1 )
2021	2021	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	30	8/4/2021	COMPETING CONTINUATION	$614,351
2021	2021	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	30	2/18/2021	COMPETING CONTINUATION	$1
2021	2020	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	29	8/4/2021	NON-COMPETING CONTINUATION	-$433,798
2021	2019	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	28	8/4/2021	NON-COMPETING CONTINUATION	-$180,553
														Subtotal = $1

Issue Date FY: 2020 ( Subtotal = $433,798 )
2020	2020	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	29	2/19/2020	NON-COMPETING CONTINUATION	$43,379
2020	2020	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	29	1/31/2020	NON-COMPETING CONTINUATION	$390,419
														Subtotal = $433,798

Issue Date FY: 2019 ( Subtotal = $446,167 )
2019	2019	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	28	2/22/2019	NON-COMPETING CONTINUATION	$446,167
2019	2018	ALBERT EINSTEIN COLLEGE OF MEDICINE, INC.	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	004	26	4/17/2019	NON-COMPETING CONTINUATION	-$320,562
2019	2018	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	27	2/8/2019	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$141,175
2019	2018	ALBERT EINSTEIN COLLEGE OF MEDICINE, INC.	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	26	2/7/2019	NON-COMPETING CONTINUATION	-$141,175
2019	2018	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	005	27	4/17/2019	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$429,360
2019	2017	ALBERT EINSTEIN COLLEGE OF MEDICINE, INC.	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	25	4/17/2019	NON-COMPETING CONTINUATION	-$108,798
														Subtotal = $446,167

Issue Date FY: 2018 ( Subtotal = $461,737 )
2018	2018	ALBERT EINSTEIN COLLEGE OF MEDICINE, INC.	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	26	1/31/2018	NON-COMPETING CONTINUATION	$415,563
2018	2018	ALBERT EINSTEIN COLLEGE OF MEDICINE, INC.	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	26	4/19/2018	NON-COMPETING CONTINUATION	$46,174
														Subtotal = $461,737

Issue Date FY: 2017 ( Subtotal = $547,319 )
2017	2017	ALBERT EINSTEIN COLLEGE OF MEDICINE, INC.	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	25	6/16/2017	NON-COMPETING CONTINUATION	$36,557
2017	2017	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	25	2/14/2017	NON-COMPETING CONTINUATION	$329,009
2017	2015	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	22	11/9/2016	COMPETING CONTINUATION	$160,753
2017	2015	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	22	11/9/2016	COMPETING CONTINUATION	$21,000
														Subtotal = $547,319

Issue Date FY: 2016 ( Subtotal = $521,377 )
2016	2016	ALBERT EINSTEIN COLLEGE OF MEDICINE INC	111 E 210TH ST	BRONX	NY	10467	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	24	1/20/2016	COMPETING CONTINUATION	$417,500
2016	2016	ALBERT EINSTEIN COLLEGE OF MEDICINE INC	111 E 210TH ST	BRONX	NY	104672401	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	24	6/15/2016	COMPETING CONTINUATION	$0
2016	2016	ALBERT EINSTEIN COLLEGE OF MEDICINE INC	111 E 210TH ST	BRONX	NY	10467	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	24	6/2/2016	COMPETING CONTINUATION	$0
2016	2016	ALBERT EINSTEIN COLLEGE OF MEDICINE INC	111 E 210TH ST	BRONX	NY	10467	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	24	6/30/2016	SUPPLEMENT FOR EXPANSION	$32,066
2016	2016	ALBERT EINSTEIN COLLEGE OF MEDICINE INC	111 E 210TH ST	BRONX	NY	10467	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	006	24	8/23/2016	SUPPLEMENT FOR EXPANSION	$71,810
2016	2015	ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIV	1300 MORRIS PARK AVENUE	BRONIX	NY	10461		USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	005	22	7/25/2016	COMPETING CONTINUATION	$11,233
2016	2015	ALBERT EINSTEIN COLLEGE OF MEDICINE INC	111 E 210TH ST	BRONX	NY	10467	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	004	23	7/25/2016	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$11,232
														Subtotal = $521,377

Issue Date FY: 2015 ( Subtotal = $346,598 )
2015	2015	ALBERT EINSTEIN COLLEGE OF MEDICINE INC	111 E 210TH ST	BRONX	NY	10467	BRONX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	23	8/19/2015	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$176,078
2015	2015	ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIV	1300 MORRIS PARK AVENUE	BRONIX	NY	10461		USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	22	1/28/2015	COMPETING CONTINUATION	$346,598
2015	2015	ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIV	1300 MORRIS PARK AVENUE	BRONIX	NY	10461		USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	22	8/19/2015	COMPETING CONTINUATION	-$176,078
2015	2015	ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIV	1300 MORRIS PARK AVENUE	BRONIX	NY	10461		USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	22	3/19/2015	COMPETING CONTINUATION	$0
														Subtotal = $346,598

Issue Date FY: 2014 ( Subtotal = $435,176 )
2014	2014	ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIV	1300 MORRIS PARK AVENUE	BRONIX	NY	10461		USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	21	3/7/2014	NON-COMPETING CONTINUATION	$435,176
														Subtotal = $435,176

Issue Date FY: 2013 ( Subtotal = $575,505 )
2013	2013	ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIV	1300 MORRIS PARK AVENUE	BRONIX	NY	10461		USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	20	1/23/2013	NON-COMPETING CONTINUATION	$309,916
2013	2013	ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIV	1300 MORRIS PARK AVENUE	BRONIX	NY	10461		USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	20	6/5/2013	NON-COMPETING CONTINUATION	$265,589
														Subtotal = $575,505

Issue Date FY: 2012 ( Subtotal = $620,196 )
2012	2012	ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIV	1300 MORRIS PARK AVENUE	BRONIX	NY	10461		USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	19	3/5/2012	NON-COMPETING CONTINUATION	$594,922
2012	2012	ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIV	1300 MORRIS PARK AVENUE	BRONIX	NY	10461		USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	19	8/2/2012	NON-COMPETING CONTINUATION	$25,274
														Subtotal = $620,196

Issue Date FY: 2011 ( Subtotal = $558,422 ) (Continued on the next page)
Grand Total All Awards = $12,382,079

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20/22 Limited Competition for the Continuation of the Diabetes Prevention Program Outcomes Study (DPPOS) – Clinical Center

Award Number: U01DK048349

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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