Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes

NCT03955952 | Completed Results

• 1 other identifier: 19-066
• Study Type: observational
• Target: 91,700
• 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.

Conditions

Obesity; Type2 Diabetes; Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• All-Cause Mortality and/or Cardiovascular Outcomes

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

  From index date through a maximum of 8 years

Secondary Outcomes (7)

• Major Adverse Cardiovascular Event (MACE-3)

  From index date through a maximum of 8 years

• All-Cause Mortality

  From index date through a maximum of 8 years

• Coronary Disease Events

  From index date through a maximum of 8 years

• Cerebrovascular Events

  From index date through a maximum of 8 years

• Heart Failure

  From index date through a maximum of 8 years

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

Limitations and Caveats

This was not a prospective randomized clinical trial. Adverse events were not collected real time and were based on retrospective chart review. The number of deaths reported in the Adverse Events section is the total deaths during the study period for both arms while the adverse events were collected for only the surgical arm. The percentages differ with the rates reported in the Endpoint section since those rates are based on the Kaplan-Meier estimator

Results Point of Contact

• Title: Dr. Ali Aminian
• Organization: Cleveland Clinic

aminiaa@ccf.org

216-444-6704

Study Officials

• Phil Schauer, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: August 3, 2026
• Results First Posted: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)