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Comparative Effectiveness and Safety of Metabolic/Bariatric Surgery, GLP-1, and SGLT-2 Medications for Patients with Obesity and Type 2 Diabetes

Award Number: R01DK135515
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: 03/06/2024
PERIOD OF PERFORMANCE END DATE: 02/29/2028

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Comparative Effectiveness and Safety of Metabolic/Bariatric Surgery, GLP-1, and SGLT-2 Medications for Patients with Obesity and Type 2 Diabetes - PROJECT SUMMARY More than 12 million Americans currently live with both obesity and type 2 diabetes (T2D), putting them in one of the highest risk groups for developing serious microvascular and macrovascular complications. The Ameri- can Diabetes Association’s clinical practice guidelines recommend metabolic/bariatric surgery (MBS) and/or pharmacologic treatment of obesity for patients with obesity and T2D. In particular, glucagon-like peptide-1 re- ceptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 inhibitors (SGLT2is) have both demonstrated efficacy in weight loss and preventing microvascular and macrovascular complications and are more accessi- ble than MBS. However, there are no long-term studies comparing GLP-1RAs or SGLT2is with MBS head-to- head with respect to effectiveness and safety, overall and in groups disproportionately affected by obesity and T2D but underrepresented in clinical trials such as racial and ethnic minority populations and rural residents. There is a clear and urgent need for large, real-world comparative effectiveness research studies to help pa- tients and their clinicians make evidence-informed decisions regarding the risks and benefits of surgical and medical approaches to reduce the long-term complications of concurrent obesity and T2D. We propose a com- parative effectiveness and safety study using administrative claims and linked electronic health record data on a diverse nationwide cohort (~40% racial/ethnic minority) of >500,000 patients with T2D and obesity treated with MBS, GLP-1RA, or SGLT-2i from 2010 to 2025, encompassing patients covered in commercial, Medicare Advantage, and 100% of Medicare fee-for-service plans. Our specific aims will compare the effectiveness of GLP-1RAs and SGLT-2is versus MBS in improving metabolic outcomes (weight, blood pressure, and hemoglo- bin A1c), reducing rates of micro- and macrovascular disease, and all-cause mortality among patients with obe- sity and T2D. We will also compare the safety of GLP-1RAs and SGLT-2is versus MBS among patients with obesity and T2D by examining rates of all-cause hospitalizations and by exploring other safety outcomes (emergency department care, severe hypoglycemia, diabetic ketoacidosis, hyperosmolar hyperglycemia, acute kidney injury, and severe genitourinary infections). A prospective randomized trial investigating these questions would be prohibitively expensive and logistically challenging to conduct given the high costs of these treat- ments and the very large sample sizes needed to examine incident micro- and macrovascular outcomes, par- ticularly in high priority patient subgroups. Our proposed study will be the largest and longest study to date comparing the real-world effectiveness and safety of GLP-1RA, SGLT-2i, and MBS to manage obesity and T2D while also generating evidence for subgroups that are often underrepresented in clinical trials. The study will provide timely and rigorous comparative effectiveness and safety evidence to help inform clinical decisions.


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 = $649,786 )
2026	2026	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	2/17/2026	NON-COMPETING CONTINUATION	$649,786
														Subtotal = $649,786

Issue Date FY: 2025 ( Subtotal = $660,172 )
2025	2025	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	6/30/2025	NON-COMPETING CONTINUATION	$66,017
2025	2025	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	2/21/2025	NON-COMPETING CONTINUATION	$594,155
														Subtotal = $660,172

Issue Date FY: 2024 ( Subtotal = $696,763 )
2024	2024	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	6/12/2024	NEW	$0
2024	2024	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	3/6/2024	NEW	$696,763
														Subtotal = $696,763

Grand Total All Awards = $2,006,721

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Comparative Effectiveness and Safety of Metabolic/Bariatric Surgery, GLP-1, and SGLT-2 Medications for Patients with Obesity and Type 2 Diabetes

Award Number: R01DK135515

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: 03/06/2024

PERIOD OF PERFORMANCE END DATE: 02/29/2028

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