Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes

Completed

• Conditions: Type2 Diabetes; Obesity; Bariatric Surgery Candidate
• Interventions: Procedure: Bariatric Surgery

• Registration Number: NCT03955952
• Lead Sponsor: The Cleveland Clinic

Brief Summary

The objective of the analysis was to evaluate the relationship between bariatric surgery and cardiovascular outcomes in obese patients with type 2 diabetes. This is a retrospective matched cohort study of patients with diabetes that underwent bariatric surgery at the Cleveland Clinic between 2004-2017. Each bariatric patient was matched to a non-surgical control with obesity and type 2 diabetes in a 1:5 ratio using data from the Electronic Medical Record (EMR). The maximum observation time was 10 years. Cumulative incidence rates for all-cause mortality and cardiovascular events were calculated at years 1, 3, 5, 7 and 10. Kaplan-Meier curves were created for all the outcomes with all-cause mortality considered as a completing risk.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-20
• Study Start: 2019-06-05
• Primary Completion: 2019-07-12
• Study Completion: 2019-08-26
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-27
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13722

Inclusion Criteria

• Type II diabetes
• 18-80 years old
• BMI>=30
• HBA1c >6.4 OR taking at lease one (1) diabetes medication (insulin or non-insulin)

Exclusion Criteria

• History of liver, heart, or lung transplant
• Emergency department admission within 5 days prior
• Cancer diagnosis within 1 year prior
• Any prior ejection fraction <20%
• Non-surgical controls were excluded if they died within 30 days after the index date (date of surgery for the bariatric patients)
• Last follow-up date on or before the index date

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bariatric Surgery	Bariatric Surgery	Patients with type 2 diabetes with BMI \>=30 that underwent bariatric surgery

Primary Outcome Measures

Name	Time	Method
Composite of All-Cause Mortality and Cardiovascular Outcomes	From index date through a maximum of 10 years	Time to first occurrence of all-cause mortality, coronary artery disease event, stroke, heart failure, nephropathy, or atrial fibrillation

Secondary Outcome Measures

Name	Time	Method
Incidence of Cerebrovascular Events	From index date through a maximum of 10 years	Time to first occurrence of ischemic or hemorrhagic stroke, carotid stenting or endarterectomy
Development of Nephropathy	From index date through a maximum of 10 years	Time to first occurrence of nephropathy defined as \>=2 measures of estimated Glomerular Filtration Rate (eGFR) \<60 ml/min/1.73m\^2 separated by at least 90 days without intervening values \>=60
Incidence of Major Adverse Cardiovascular Event (MACE-3)	From index date through a maximum of 10 years	Time to first occurrence of all-cause mortality, myocardial infarction or ischemic stroke
Incidence of Coronary Disease Events	From index date through a maximum of 10 years	Time to first occurrence of myocardial infarction, unstable angina, percutaneous coronary intervention, or coronary artery bypass grafting
All-Cause Mortality	From index date through a maximum of 10 years	Time to occurrence of death from any cause
Incidence of Atrial Fibrillation	From index date through a maximum of 10 years	Time to first occurrence of atrial fibrillation defined by the following codes: International Classification of Diseases ICD-9: 427.31 ICD-10: i48.0, i48.1, i48.2, i48.91 Current Procedural Terminology (CPT): 93650, 93653, 93656, 93657
Incidence of Heart Failure	From index date through a maximum of 10 years	Time to first occurrence of heart failure

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States