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Surgical or Medical Treatment for Pediatric Type 2 Diabetes (ST2OMP)

Award Number: R01DK119450
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: 06/30/2025

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Surgical or Medical Treatment for Pediatric Type 2 Diabetes (ST2OMP) - PROJECT SUMMARY Youth-onset type 2 diabetes (T2D) leads to early dependence on exogenous insulin and progression of T2D co-morbidities, including dyslipidemia, hypertension, non-alcoholic fatty liver disease and diabetic kidney dis- ease. The pathophysiology of T2D in youth differs considerably from adults and current treatment approaches are inadequate for youth. Thus, exploration of innovative approaches to reduce co-morbidities is critical. Meta- bolic bariatric surgery (MBS) significantly improves multiple outcomes in adults with T2D. Initial small, uncon- trolled studies of Roux-en-Y gastric bypass also suggest beneficial effects in youth with T2D, but definitive studies and understanding of mechanisms in youth-onset T2D are lacking, especially with the now more com- mon form of MBS, vertical sleeve gastrectomy (VSG). Our long-term goal is to improve the treatment of youth- onset T2D to reduce morbidity and mortality. Our central hypothesis is that VSG will be more effective in reduc- ing glycemia and comorbidities than the best currently available medical treatment: advanced medical therapy (AMT), via pancreatic, enterohepatic and/or metabolic changes. To test this hypothesis, we will enroll 90 ado- lescents with T2D across two sites and compare the effects of VSG vs. AMT on glycemic control and T2D-as- sociated comorbidities, as well as underlying mechanisms. Our sites have collaborative pediatric medical and surgical expertise, including use of non-invasive metabolic measures in MBS and T2D and collectively have a large, diverse adolescent T2D cohort, making us uniquely positioned to accomplish these aims. Our rationale is that 1) there is a critical need to determine the impact of VSG over AMT in youth-onset T2D, and 2) im- proved knowledge of the mechanisms underlying the impact of MBS will direct future non-surgical approaches to mimic MBS less invasively. Aim 1 will evaluate the effects of VSG vs. AMT on glycemic control and T2D- associated co-morbidities. We hypothesize that a higher proportion of youth with T2D receiving VSG vs. AMT will achieve the primary endpoint of HbA1c <6% with higher rates of remission (lower incidence) of comorbidi- ties at 1 and 2 years. We will also explore the impact of T2D duration, BMI, sex and initial HbA1c on the pri- mary outcome. Aim 2 will elucidate mechanisms by which VSG & AMT influence pancreatic islet cell function, enterohepatic metabolism and tissue-specific insulin sensitivity, and their contributions to glycemic control in youth with T2D. We hypothesize that the primary outcome of β-cell function will improve in T2D youth undergo- ing VSG vs. AMT at 1 and 2 years. Secondary endpoints include whole-body IR, tissue-specific IR, incretin re- sponse and α-cell function to understand mechanisms underlying improvements. These results will determine whether MBS is more effective than AMT in promoting glycemic control and reducing co-morbidities in youth- onset T2D, an outcome that would dramatically improve the lives of youth who currently have a dismal progno- sis. Further, this proposal will help understand the mechanisms underlying MBS in youth, to guide the develop- ment of future treatments that could target these same pathways without the need for surgery.


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 = $0 )
2026	2023	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	1/6/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $647,956 )
2023	2023	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	7/10/2023	NON-COMPETING CONTINUATION	$647,956
														Subtotal = $647,956

Issue Date FY: 2022 ( Subtotal = $655,729 )
2022	2022	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	9/1/2022	NON-COMPETING CONTINUATION	$655,729
2022	2021	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	1/4/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $655,729

Issue Date FY: 2021 ( Subtotal = $661,485 )
2021	2021	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	8/28/2021	NON-COMPETING CONTINUATION	$661,485
														Subtotal = $661,485

Issue Date FY: 2020 ( Subtotal = $669,713 )
2020	2020	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	8/26/2020	NON-COMPETING CONTINUATION	$669,713
														Subtotal = $669,713

Issue Date FY: 2019 ( Subtotal = $690,402 )
2019	2019	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/11/2019	NEW	$690,402
														Subtotal = $690,402

Grand Total All Awards = $3,325,285

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Surgical or Medical Treatment for Pediatric Type 2 Diabetes (ST2OMP)

Award Number: R01DK119450

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: 06/30/2025

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