Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes

NCT ID: NCT03955952

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13722 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-05
• Study Completion Date: 2019-08-26

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.

Conditions

Obesity; Type2 Diabetes; Bariatric Surgery Candidate

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Bariatric Surgery

Patients with type 2 diabetes with BMI \>=30 that underwent bariatric surgery

Bariatric Surgery

Intervention Type: PROCEDURE

Patients chosen using the following codes:

Current Procedural Terminology (CPT): 43633, 43634, 43770, 43775, 43644, 43645, 43659, 43842, 43843, 43844, 43845, 43846, 43847 International Classification of Diseases (ICD): 44.31, 43.82,44.95, 43.89, 44.38, 44.39, 44.68 Healthcare Common Procedure Coding System (HCPCS): S2082, S2085

Non-Surgical Control

Matched non-surgical controls with type 2 diabetes and BMI \>=30

No interventions assigned to this group

Interventions

Bariatric Surgery

Patients chosen using the following codes:

Current Procedural Terminology (CPT): 43633, 43634, 43770, 43775, 43644, 43645, 43659, 43842, 43843, 43844, 43845, 43846, 43847 International Classification of Diseases (ICD): 44.31, 43.82,44.95, 43.89, 44.38, 44.39, 44.68 Healthcare Common Procedure Coding System (HCPCS): S2082, S2085

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Ali Aminian

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Phil Schauer, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

References

Aminian A, Zajichek A, Arterburn DE, Wolski KE, Brethauer SA, Schauer PR, Kattan MW, Nissen SE. Association of Metabolic Surgery With Major Adverse Cardiovascular Outcomes in Patients With Type 2 Diabetes and Obesity. JAMA. 2019 Oct 1;322(13):1271-1282. doi: 10.1001/jama.2019.14231.

Reference Type: DERIVED

PMID: 31475297 (View on PubMed)

Other Identifiers

19-066

Identifier Type: -

Identifier Source: org_study_id