Macrovascular and Microvascular Morbidity and Mortality After Metabolic Surgery Versus Medicines

Obesity Clinical Trial

— M6  

Official title:

Macrovascular and Microvascular Outcomes in Patients With Type 2 Diabetes and Obesity: Comparison of Metabolic Surgery Versus GLP-1 Receptor Agonists

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06355219
• Other study ID #: IRB #19-066
• Status: Active, not recruiting
• Start date: January 1, 2010
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3932
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• All Cause Mortality
• Diabetes Mellitus, Type 2
• Heart Failure
• Major Adverse Cardiovascular Events
• Microvascular Disease
• Nephropathy
• Obesity
• Retinopathy
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ali Aminian

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Components of MACE Separately	Incidence of each of the following MACE components separately: 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.	After surgical or assigned index date to Dec 31, 2022
Other	Change in weight percentage	Relative change in weight percentage at follow up compared to index date	After surgical or assigned index date to Dec 31, 2022
Other	Change HBA1c percentage	Absolute change HBA1c percentage at follow up compared to index date	After surgical or assigned index date to Dec 31, 2022
Other	Trends of prescription and dispenses of medications for T2DM and cardio-vascular conditions	Using dates of prescription orders and dispenses of medications for T2DM and cardio-vascular conditions	After surgical or assigned index date to Dec 31, 2022
Other	Progression of Chronic Kidney Disease (CKD) in Patients with CKD stages 3 and 4 at baseline	Defined as onset of = 50% sustained decline in eGFR compared with baseline, onset of sustained eGFR <15 mL/min/1.73 m2, initiation of dialysis, or kidney transplant after the index date.	After surgical or assigned index date to Dec 31, 2022
Other	Cost-effectiveness of Metabolic Surgery vs GLP-1RAs	Defined as the cost per life year and the cost per quality adjusted life year (QALY) in the surgical and nonsurgical patients.	After surgical or assigned index date to Dec 31, 2022
Other	Incidence of Adverse Events After Metabolic Surgery	Serious complications following surgery include bleeding requiring transfusion, pulmonary adverse events, venous thromboembolism, cardiac events, renal failure requiring dialysis, gastrointestinal leak, bowel obstruction requiring surgery, gastric/anastomotic stricture or ulcer, and sepsis.	90 days after surgical index date
Primary	All-cause Mortality Rate	Death from all causes percentage	After surgical or assigned index date to Dec 31, 2022
Secondary	Incidence of MACE	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.	After surgical or assigned index date to Dec 31, 2022
Secondary	Incidence of Nephropathy	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.	After surgical or assigned index date to Dec 31, 2022
Secondary	Incidence of Retinopathy	(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	After surgical or assigned index date to Dec 31, 2022