Comparative effectiveness and safety of metabolic/bariatric surgery, GLP-1, and sglt-2 medications for patients with obesity and type 2 diabetes

Active Project Grant Awarded Last action

Award ID
R01DK135515
Recipient
Awarding agency
Obligated
$4,060,419

Award facts

Completion date 66% complete
Place of performance
Seattle, WA 98101, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
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.

Transactions

Action Obligated Date
Amendment $649,786
Amendment $66,017
Amendment $66,017
Amendment $594,155
Amendment $594,155
Amendment $0
Amendment $0
Amendment $696,763
Amendment $696,763
Original award $696,763

Subawards

Subrecipient Amount Awarded
University Of Maryland, Baltimore As the site Pl on this project, Dr. O'Connor will serve as the Co-Investigator on a research team led by Co-Pis Ors. Rozalina McCoy and David Arterburn. He will… $331,055
Healthpartners Institute $34,570
Touro University "The aims of this project are: (1) to identify longitudinal medication adherence trajectories (MATs) of older people ( 50years) living with HIV (PLWH) and… $65,736
University Of Maryland, Baltimore "Dr. McCoy will provide subject matter expertise in type 2 diabetes and obesity management, and analysis of administrative claims data. She will oversee the… $33,964
Healthpartners Institute As the site Pl on this project, Dr. O'Connor will serve as the Co-Investigator on a research team led by Co-Pis Ors. Rozalina McCoy and David Arterburn. He will… $31,113
University Of Maryland, Baltimore "Dr. McCoy will provide subject matter expertise in type 2 diabetes and obesity management, and analysis of administrative claims data. She will oversee the… $275,061
University Of Maryland, Baltimore Dr. McCoy will provide subject matter expertise in type 2 diabetes and obesity management, and analysis of administrative claims data. She will oversee the Data… $311,165
Healthpartners Institute As the site PI on this project, Dr. O’Connor will serve as the Co-Investigator on a research team led by Co-PIs Drs. Rozalina McCoy and David… $34,570

Quick answers

Who received award R01DK135515?

R01DK135515 was awarded to Kaiser Foundation Hospitals by National Institute of Diabetes and Digestive and Kidney Diseases (National Institutes of Health) on March 6, 2024.

How much is award R01DK135515 worth?

$4,060,419 has been obligated on R01DK135515.

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