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Effects of Biomedical Risk Factors on Neuro-cognition Using MRI: Long term follow-up of the Diabetes Control & Complications Trial/Epidemiology of Diabetes Interventions and Complications Study Cohort

Award Number: DP3DK114812
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Effects of Biomedical Risk Factors on Neuro-cognition Using MRI: Long term follow-up of the Diabetes Control & Complications Trial/Epidemiology of Diabetes Interventions and Complications Study Cohort - Abstract The extent, nature and pathogenesis of neuro-cognitive impairments among individuals with type 1 diabetes (T1DM) are poorly understood. Patients with T1DM are living longer and thus are commonly entering an age (50+) when such impairments become more evident, but are, as yet, understudied. Past, small studies suggest aspects of cognition, brain structure, function and chemistry that may be affected by T1DM and may increase in severity and clinical importance with aging. The Diabetes Control & Complications Trial/Epidemiology of Diabetes Interventions & Complications (DCCT/EDIC) study affords an unparalleled opportunity to use longitudinal data gathered over 30 years from early in the course of illness, among this well- characterized cohort, to examine important and unresolved questions about the frequency and pathogenesis of neuro-cognitive impairments as patients enter the age of highest risk. DCCT/EDIC participants have had continuously high rates of participation (currently 94% of the surviving cohort), and are now returning for an additional five years of follow-up (2017-2022) for ongoing and new biomedical assessments including evaluation of cognitive functioning and depression. This application, submitted in response to RFA-DK-16-007, will leverage available data collected in this cohort from past evaluations and from the new planned 5-year follow-up. We plan to assess effects of risk factors including: exposure to hyperglycemia as documented by HbA1c measurements during DCCT/EDIC, recurrent severe hypoglycemic events, variation in glycemia using continuous glucose monitoring (CGM ), history of hypertension, hyperlipidemia, and presence of micro- vascular and macro-vascular complications on the integrity of the brain evaluated by magnetic resonance imaging (MRI), and the association of brain changes with neuro-retinal degeneration assessed by a novel method-Ocular Coherence Tomography (OCT). We hypothesize that the presence of T1DM, prior conventional DCCT treatment assignment, elevated HbA1c levels and history of severe hypoglycemia will lead to reduced total brain volume, our primary outcome, and also result in detectable vascular, neuro-degenerative, neuro- chemical and functional changes assessed by MRI. In addition, we postulate that these primary risk factors in concert with other secondary risk factors (e.g.: glycemic variation, hypertension & micro-vascular and macro- vascular disease), will differentially affect frontal & temporal regions. Changes in the brain will be associated with decreased cognitive functioning, especially on measures of psychomotor efficiency. To reach these goals 400 T1DM subjects from the DCCT/EDIC cohort randomly selected to represent a broad range of biomedical outcomes will be compared with a non-diabetic control population (n=100) of similar age and social/educational background using identical cognitive and neuro-imaging techniques. Completion of these aims will determine key predictors of neuro-cognitive impairments in patients with T1DM and guide personalized strategies to mitigate this risk in providing clinical care for patients with T1DM.


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: 2022 ( Subtotal = -$230,364 )
2022	2019	NEW YORK UNIVERSITY	101 MINEOLA BLVD	MINEOLA	NY	11501	NASSAU	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	004	2	9/22/2022	SUPPLEMENT FOR EXPANSION	-$78,030
2022	2019	NYU WINTHROP HOSPITAL	259 FIRST ST	MINEOLA	NY	11501	NASSAU	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	3/7/2022	SUPPLEMENT FOR EXPANSION	-$1,866
2022	2017	NEW YORK UNIVERSITY	101 MINEOLA BLVD	MINEOLA	NY	11501	NASSAU	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	2	9/22/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$152,334
2022	2017	NEW YORK UNIVERSITY	101 MINEOLA BLVD	MINEOLA	NY	11501	NASSAU	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	2	3/7/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,866
2022	2017	NEW YORK UNIVERSITY	101 MINEOLA BLVD	MINEOLA	NY	11501	NASSAU	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	11/18/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = -$230,364

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	NYU WINTHROP HOSPITAL	259 FIRST ST	MINEOLA	NY	11501	NASSAU	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	1	8/5/2021	SUPPLEMENT FOR EXPANSION	$0
2021	2019	NYU WINTHROP HOSPITAL	259 FIRST ST	MINEOLA	NY	11501	NASSAU	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	004	1	8/5/2021	SUPPLEMENT FOR EXPANSION	-$78,030
2021	2019	NEW YORK UNIVERSITY	101 MINEOLA BLVD	MINEOLA	NY	11501	NASSAU	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	005	2	9/8/2021	SUPPLEMENT FOR EXPANSION	$78,030
2021	2017	NYU WINTHROP HOSPITAL	259 FIRST ST	MINEOLA	NY	11501	NASSAU	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	1	8/5/2021	NEW	$0
2021	2017	NYU WINTHROP HOSPITAL	259 FIRST ST	MINEOLA	NY	11501	NASSAU	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	7/29/2021	NEW	-$1,349,975
2021	2017	NEW YORK UNIVERSITY	101 MINEOLA BLVD	MINEOLA	NY	11501	NASSAU	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	7/29/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,349,975
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $477,940 )
2019	2019	NYU WINTHROP HOSPITAL	259 FIRST ST	MINEOLA	NY	11501	NASSAU	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	2/13/2019	SUPPLEMENT FOR EXPANSION	$76,344
2019	2019	NYU WINTHROP HOSPITAL	259 FIRST ST	MINEOLA	NY	11501	NASSAU	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	7/19/2019	SUPPLEMENT FOR EXPANSION	$401,596
														Subtotal = $477,940

Issue Date FY: 2017 ( Subtotal = $4,232,222 )
2017	2017	WINTHROP-UNIVERSITY HOSPITAL INC	259 FIRST ST	MINEOLA	NY	11501	NASSAU	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	7/3/2017	NEW	$4,232,222
														Subtotal = $4,232,222

Grand Total All Awards = $4,479,798

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Effects of Biomedical Risk Factors on Neuro-cognition Using MRI: Long term follow-up of the Diabetes Control & Complications Trial/Epidemiology of Diabetes Interventions and Complications Study Cohort

Award Number: DP3DK114812

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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