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Skeletal Effects of Type 1 Diabetes

Award Number: R01DK122558
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/12/2019
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Skeletal Effects of Type 1 Diabetes - This application responds to the RFA titled, “Understanding Skeletal Effects of Type 1 Diabetes”, FOA RFA- DK-18-002. Low-trauma (osteoporotic) fractures are epidemic in the U.S. and the world(1-7). About 50% of the variation in risk of these fractures is due to low bone density, and the remaining 50% is due to defective mechanical properties of bone tissue(8). Diabetics suffer a significantly higher incidence of osteoporotic fractures than do non-diabetics(9-13), and their bone densities are higher at the time of fracture than in fracturing non-diabetic patients(13). These mechanical defects may be the result of episodes of hyperglycemia which could cause accumulation of compounds, such as advanced glycation end-products (AGEs) that weaken bone mechanical properties(14-16). These compounds accumulate in many tissues in diabetics(14-18), and this has stimulated some interest in the development of anti-glycation treatments because of their therapeutic potential. Indeed, one approved osteoporosis anti-fracture drug, raloxifene, has been shown to reduce fractures in non-diabetic osteoporotics without the usual accompanying increase in bone mass(19-22). It has also been shown to reduce the concentration AGEs in bone in an animal model(23), and improves bone mechanical strength by increasing matrix-bound water(24). Our hypotheses are: 1. Type 1 diabetics have greater risk of osteoporotic fractures for any given bone density due to reduced mechanical quality of their bone tissue, and 2. This mechanical defect is due to excess accumulation of chemicals such as AGEs, and to loss of bone tissue-bound water(17;24). Our study plan is to recruit 40 female, postmenopausal, type 1 insulin- dependent diabetics, who are over age 50, and have had diabetes for 10 – 30 years. We will perform 2 transilial bone biopsies(25) on each subject, one for mechanical testing(25) and imaging,(26;27), and the other for tissue analysis of AGEs, other candidate chemicals, and bone tissue-bound water(28). A matched, non- diabetic, healthy control will be recruited at the time each diabetic is recruited and biopsied as in our previous study of 60 fracturing patients, each compared with 60 matched controls(25). Heretofore, we have not had FDA approval for the use of agents such as raloxifene(19;21;23;24;29) for prevention of fractures in diabetics, and thus they are rarely prescribed. The ultimate goal of this study is to provide more documentation of the cause of the excess fracture burden in diabetics in order to encourage development of treatment options, i.e. anti-glycation compounds, for their prevention. The absence of approved pharmaceutical options for reduction of fracture-risk in diabetics represents a serious problem for the large population of diabetics, and the results of this work are necessary on behalf of these patients.


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	CREIGHTON UNIVERSITY	2500 CALIFORNIA PLAZA	OMAHA	NE	68178	DOUGLAS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	8/13/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $341,725 )
2024	2024	CREIGHTON UNIVERSITY	2500 CALIFORNIA PLAZA	OMAHA	NE	68178	DOUGLAS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	8/15/2024	NON-COMPETING CONTINUATION	$341,725
														Subtotal = $341,725

Issue Date FY: 2023 ( Subtotal = $341,196 )
2023	2023	CREIGHTON UNIVERSITY	2500 CALIFORNIA PLAZA	OMAHA	NE	68178	DOUGLAS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	8/22/2023	NON-COMPETING CONTINUATION	$341,196
2023	2021	CREIGHTON UNIVERSITY	2500 CALIFORNIA PLAZA	OMAHA	NE	68178	DOUGLAS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	4/25/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $341,196

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	CREIGHTON UNIVERSITY	2500 CALIFORNIA PLAZA	OMAHA	NE	68178	DOUGLAS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	6/22/2022	NON-COMPETING CONTINUATION	$0
2022	2021	CREIGHTON UNIVERSITY	2500 CALIFORNIA PLAZA	OMAHA	NE	68178	DOUGLAS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	9/1/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $343,972 )
2021	2021	CREIGHTON UNIVERSITY	2500 CALIFORNIA PLAZA	OMAHA	NE	68178	DOUGLAS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	8/9/2021	NON-COMPETING CONTINUATION	$343,972
														Subtotal = $343,972

Issue Date FY: 2020 ( Subtotal = $334,229 )
2020	2020	CREIGHTON UNIVERSITY	2500 CALIFORNIA PLAZA	OMAHA	NE	68178	DOUGLAS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	7/23/2020	NON-COMPETING CONTINUATION	$334,229
														Subtotal = $334,229

Issue Date FY: 2019 ( Subtotal = $351,127 )
2019	2019	CREIGHTON UNIVERSITY	2500 CALIFORNIA PLAZA	OMAHA	NE	68178	DOUGLAS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	9/17/2019	NEW	$0
2019	2019	CREIGHTON UNIVERSITY	2500 CALIFORNIA PLAZA	OMAHA	NE	68178	DOUGLAS	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/12/2019	NEW	$351,127
														Subtotal = $351,127

Grand Total All Awards = $1,712,249

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Skeletal Effects of Type 1 Diabetes

Award Number: R01DK122558

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/12/2019

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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