Macrovascular and Microvascular Morbidity and Mortality After Metabolic Surgery Versus Medicines (M6)

Ali Aminian

Status: Completed

Conditions: Macrovascular Disease; Retinopathy; Nephropathy; Major Adverse Cardiovascular Events; Type 2 Diabetes Mellitus; Obesity; Heart Failure; Microvascular Disease; All Cause Mortality

Study type: Observational

Funder types: Other

Identifiers

NCT06355219

IRB #19-066

Details and patient eligibility

About

The goal of this study is to compare the impact of metabolic surgery and a class of anti-diabetes medications (Glucagon-like peptide-1 receptor agonists,GLP-1 RAs) on occurrence of diseases involving small and large vessels such as heart disease, kidney disease, and disease of the retina (a part of the eye), as well as deaths.

Enrollment: 3,932 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI>=30 kg/m^2
• Type 2 Diabetes Mellitus
• 18-75 y/o
• Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) (Surgical Cohort) at CCHS hospitals in Florida and Ohio between January 1, 2010, and December 31, 2017

For the GLP-1RA Group:

• Follow-up of at least 30 days after the assigned index date
• Did not meet any of the exclusion criteria for surgical patients (see below)
• Did not have metabolic surgery prior to assigned index date.
• Continuously received GLP-1 RA for ≥2 years (prescription order for GLP-1 RA placed between January 1, 2010, and December 31, 2017, as well as ≥ 3 documented prescription fills within 1 year before their assigned index date and ≥ 3 fills within 1 year after their index date)

Exclusion criteria

• History of solid organ transplant
• Cardiac ejection fraction <20% any time before index date
• Active cancer
• Cancer code within 1 year before index date
• ED admission within 5 days before index date
• Dialysis or estimated glomerular filtration rate (eGFR) <20 before index date.
• Received care in CCHS locations other than in Ohio and Florida.

Trial design

3,932 participants in 2 patient groups

Metabolic Surgery

Description:

Patients aged 18 years to 75 years, who had a BMI ≥30 and T2DM at the time of surgery, and who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) at Cleveland Clinic Health System(CCHS) hospitals in Florida and Ohio between January 1, 2010, and December 31, 2017.

GLP-1 RAs

Description:

Non-surgical patients at CCHS who at randomly assigned index dates had T2DM and obesity, follow-up of at least 30 days after the assigned index date, did not meet any of the exclusion criteria for surgical patients, and did not have metabolic surgery prior to the assigned index date, who continuously received GLP-1 RA for ≥2 years, defined by prescription order for GLP-1 RA placed between January 1, 2010, and December 31, 2017, as well as ≥ 3 documented prescription fills within 1 year before their assigned index date and ≥ 3 fills within 1 year after their index date.