Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes

NCT03955952 | Completed

• 1 other identifier: 19-066
• Study Type: observational
• Target: 13,722
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Composite of All-Cause Mortality and Cardiovascular Outcomes

  Time to first occurrence of all-cause mortality, coronary artery disease event, stroke, heart failure, nephropathy, or atrial fibrillation

  From index date through a maximum of 10 years

Secondary Outcomes (7)

• Incidence of Major Adverse Cardiovascular Event (MACE-3)

  From index date through a maximum of 10 years

• All-Cause Mortality

  From index date through a maximum of 10 years

• Incidence of Coronary Disease Events

  From index date through a maximum of 10 years

• Incidence of Cerebrovascular Events

  From index date through a maximum of 10 years

• Incidence of Heart Failure

  From index date through a maximum of 10 years

Other Outcomes (7)

• Percentage Change in Body Weight

  1,3 and 5 years post-index date

• Percentage Change in Hemoglobin A1c

  1,3 and 5 years post-index date

• Percentage Change in Systolic Blood Pressure (SBP)

  1,3 and 5 years post-index date

Study Arms (2)

Bariatric Surgery

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

Procedure: Bariatric Surgery

Non-Surgical Control

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

Interventions

Bariatric Surgery 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

Bariatric Surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Type 2 diabetes patients with obesity (BMI\>=30) between 18-80 years old.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 31475297 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Phil Schauer, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 20, 2019
• Study Start: June 5, 2019
• Primary Completion: July 12, 2019
• Study Completion: August 26, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)