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Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes

NeuroTherapia, Inc. logo

NeuroTherapia, Inc.

Status

Completed

Conditions

Type2 Diabetes
Bariatric Surgery Candidate
Obesity

Treatments

Procedure: Bariatric Surgery

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

13,722 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

13,722 participants in 2 patient groups

Bariatric Surgery
Description:
Patients with type 2 diabetes with BMI \>=30 that underwent bariatric surgery
Treatment:
Procedure: Bariatric Surgery
Non-Surgical Control
Description:
Matched non-surgical controls with type 2 diabetes and BMI \>=30

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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