Macrovascular and Microvascular Morbidity and Mortality After Metabolic Surgery Versus Medicines

Completed

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

• Registration Number: NCT06355219
• Lead Sponsor: Ali Aminian

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2022-12-31
• Study First Submitted: 2024-03-29
• Study First Submitted QC: 2024-04-03
• Study First Posted: 2024-04-09
• Status Verified: 2024-05
• Study Completion: 2024-05-20
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3932

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause Mortality Rate	After surgical or assigned index date to Dec 31, 2022	Death from all causes percentage

Secondary Outcome Measures

Name	Time	Method
Incidence of MACE	After surgical or assigned index date to Dec 31, 2022	Incident major adverse cardiovascular events (MACE, composite of 4 outcomes), defined as the first occurrence of coronary artery events (unstable angina, myocardial infarction, or coronary intervention/surgery), cerebrovascular events (ischemic stroke, hemorrhagic stroke, or carotid intervention/surgery), heart failure, or atrial fibrillation.
Incidence of Retinopathy	After surgical or assigned index date to Dec 31, 2022	(1) First occurrence of retinopathy in patients who did not have such events at baseline or (2) progression to a more severe form of retinopathy in those with baseline retinopathy
Incidence of Nephropathy	After surgical or assigned index date to Dec 31, 2022	Onset of ≥40% sustained decline in eGFR compared with baseline (calculated using the 2021 CKD-EPI equation), onset of sustained eGFR \<15 mL/min/1.73 m\^2, initiation of dialysis, or kidney transplant.