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9/22 Limited Competition for Continuation of the Diabetes Prevention Program Outcomes Study (DPPOS) - Clinical Center

Award Number: U01DK048411
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 = -$6,952 )
2024	2022	UNIVERSITY OF TENNESSEE	62 S DUNLAP ST	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	28	10/27/2023	SUPPLEMENT FOR EXPANSION	-$6,952
														Subtotal = -$6,952

Issue Date FY: 2022 ( Subtotal = $70,473 )
2022	2022	UNIVERSITY OF TENNESSEE	62 S DUNLAP STREET STE 103	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	28	7/1/2022	SUPPLEMENT FOR EXPANSION	$70,473
2022	2021	UNIVERSITY OF TENNESSEE	62 S DUNLAP STREET STE 103	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	28	3/22/2022	COMPETING CONTINUATION	$0
2022	2021	UNIVERSITY OF TENNESSEE	62 S DUNLAP STREET STE 103	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	28	1/20/2022	COMPETING CONTINUATION	$0
														Subtotal = $70,473

Issue Date FY: 2021 ( Subtotal = $225,708 )
2021	2021	UNIVERSITY OF TENNESSEE	62 S DUNLAP STREET STE 103	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	004	28	6/8/2021	COMPETING CONTINUATION	$274,867
2021	2021	UNIVERSITY OF TENNESSEE	62 S DUNLAP STREET STE 103	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	28	3/18/2021	COMPETING CONTINUATION	$225,708
2021	2020	UNIVERSITY OF TENNESSEE	62 S DUNLAP STREET STE 103	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	27	1/26/2021	NON-COMPETING CONTINUATION	$0
2021	2020	UNIVERSITY OF TENNESSEE	62 S DUNLAP STREET STE 103	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	27	6/8/2021	NON-COMPETING CONTINUATION	-$242,758
2021	2019	UNIVERSITY OF TENNESSEE	62 S DUNLAP STREET STE 103	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	26	6/8/2021	NON-COMPETING CONTINUATION	-$32,109
														Subtotal = $225,708

Issue Date FY: 2020 ( Subtotal = $242,758 )
2020	2020	UNIVERSITY OF TENNESSEE	62 S DUNLAP STREET STE 103	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	27	1/31/2020	NON-COMPETING CONTINUATION	$218,482
2020	2020	UNIVERSITY OF TENNESSEE	62 S DUNLAP STREET STE 103	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	27	2/19/2020	NON-COMPETING CONTINUATION	$24,276
2020	2019	UNIVERSITY OF TENNESSEE	62 S DUNLAP STREET STE 103	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	26	2/19/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $242,758

Issue Date FY: 2019 ( Subtotal = $280,654 )
2019	2019	UNIVERSITY OF TENNESSEE	62 S DUNLAP STREET STE 103	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	26	2/14/2019	NON-COMPETING CONTINUATION	$280,654
														Subtotal = $280,654

Issue Date FY: 2018 ( Subtotal = $260,305 )
2018	2018	UNIVERSITY OF TENNESSEE	62 S DUNLAP STREET STE 103	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	25	4/20/2018	NON-COMPETING CONTINUATION	$31,031
2018	2018	UNIVERSITY OF TENNESSEE	62 S DUNLAP STREET STE 103	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	25	2/1/2018	NON-COMPETING CONTINUATION	$229,274
														Subtotal = $260,305

Issue Date FY: 2017 ( Subtotal = $166,396 )
2017	2017	UNIVERSITY OF TENNESSEE	62 S DUNLAP STREET STE 103	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	24	6/15/2017	NON-COMPETING CONTINUATION	$16,640
2017	2017	UNIVERSITY OF TENNESSEE	62 S DUNLAP STREET STE 103	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	24	2/9/2017	NON-COMPETING CONTINUATION	$149,756
														Subtotal = $166,396

Issue Date FY: 2016 ( Subtotal = $313,274 )
2016	2016	UNIVERSITY OF TENNESSEE CENTER FOR THE HEALTH SCIENCES	62 SOUTH DUNLAP STREET	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	23	6/2/2016	COMPETING CONTINUATION	$0
2016	2016	UNIVERSITY OF TENNESSEE CENTER FOR THE HEALTH SCIENCES	62 SOUTH DUNLAP STREET	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	23	1/19/2016	COMPETING CONTINUATION	$228,000
2016	2016	UNIVERSITY OF TENNESSEE CENTER FOR THE HEALTH SCIENCES	62 SOUTH DUNLAP STREET	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	004	23	8/23/2016	SUPPLEMENT FOR EXPANSION	$56,240
2016	2016	UNIVERSITY OF TENNESSEE CENTER FOR THE HEALTH SCIENCES	62 SOUTH DUNLAP STREET	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	23	6/30/2016	SUPPLEMENT FOR EXPANSION	$29,034
2016	2016	UNIVERSITY OF TENNESSEE CENTER FOR THE HEALTH SCIENCES	62 SOUTH DUNLAP STREET	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	23	6/15/2016	COMPETING CONTINUATION	$0
														Subtotal = $313,274

Issue Date FY: 2015 ( Subtotal = $246,272 )
2015	2015	UNIVERSITY OF TENNESSEE CENTER FOR THE HEALTH SCIENCES	62 SOUTH DUNLAP STREET	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	22	3/19/2015	COMPETING CONTINUATION	$0
2015	2015	UNIVERSITY OF TENNESSEE CENTER FOR THE HEALTH SCIENCES	62 SOUTH DUNLAP STREET	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	22	1/28/2015	COMPETING CONTINUATION	$246,272
														Subtotal = $246,272

Issue Date FY: 2014 ( Subtotal = $367,760 )
2014	2014	UNIVERSITY OF TENNESSEE CENTER FOR THE HEALTH SCIENCES	62 SOUTH DUNLAP STREET	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	21	3/7/2014	NON-COMPETING CONTINUATION	$367,760
														Subtotal = $367,760

Issue Date FY: 2013 ( Subtotal = $558,403 )
2013	2013	UNIVERSITY OF TENNESSEE CENTER FOR THE HEALTH SCIENCES	62 SOUTH DUNLAP STREET	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	20	6/5/2013	NON-COMPETING CONTINUATION	$271,708
2013	2013	UNIVERSITY OF TENNESSEE CENTER FOR THE HEALTH SCIENCES	62 SOUTH DUNLAP STREET	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	20	1/23/2013	NON-COMPETING CONTINUATION	$286,695
														Subtotal = $558,403

Issue Date FY: 2012 ( Subtotal = $568,722 )
2012	2012	UNIVERSITY OF TENNESSEE CENTER FOR THE HEALTH SCIENCES	62 SOUTH DUNLAP STREET	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	19	8/31/2012	NON-COMPETING CONTINUATION	$25,215
2012	2012	UNIVERSITY OF TENNESSEE CENTER FOR THE HEALTH SCIENCES	62 SOUTH DUNLAP STREET	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	19	3/6/2012	NON-COMPETING CONTINUATION	$543,507
														Subtotal = $568,722

Issue Date FY: 2011 ( Subtotal = $436,437 )
2011	2011	UNIVERSITY OF TENNESSEE CENTER FOR THE HEALTH SCIENCES	62 SOUTH DUNLAP STREET	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	18	2/16/2011	NON-COMPETING CONTINUATION	$382,793
2011	2011	UNIVERSITY OF TENNESSEE CENTER FOR THE HEALTH SCIENCES	62 SOUTH DUNLAP STREET	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	18	7/25/2011	NON-COMPETING CONTINUATION	$53,644
														Subtotal = $436,437

Issue Date FY: 2010 ( Subtotal = $510,437 )
2010	2010	UNIVERSITY OF TENNESSEE CENTER FOR THE HEALTH SCIENCES	62 SOUTH DUNLAP STREET	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	17	2/19/2010	NON-COMPETING CONTINUATION	$510,437
														Subtotal = $510,437

Issue Date FY: 2009 ( Subtotal = $491,520 )
2009	2009	UNIVERSITY OF TENNESSEE CENTER FOR THE HEALTH SCIENCES	62 SOUTH DUNLAP STREET	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	16	3/25/2009	COMPETING CONTINUATION	$491,520
2009	2008	UNIVERSITY OF TENNESSEE CENTER FOR THE HEALTH SCIENCES	62 SOUTH DUNLAP STREET	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	15	2/12/2009	NON-COMPETING CONTINUATION	$0
2009	2008	UNIVERSITY OF TENNESSEE CENTER FOR THE HEALTH SCIENCES	62 SOUTH DUNLAP STREET	MEMPHIS	TN	38103	SHELBY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	15	3/25/2009	NON-COMPETING CONTINUATION	$0
														Subtotal = $491,520

Grand Total All Awards = $10,168,866

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9/22 Limited Competition for Continuation of the Diabetes Prevention Program Outcomes Study (DPPOS) - Clinical Center

Award Number: U01DK048411

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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