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Clinical Trials/NCT06420479
NCT06420479
Recruiting
Not Applicable

The Causal Effect of Bariatric Surgery on Cardiovascular Disease and Mortality

Karolinska Institutet1 site in 1 country100,000 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bariatric Surgery Candidate
Sponsor
Karolinska Institutet
Enrollment
100000
Locations
1
Primary Endpoint
Cardiovascular disease
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The association between weight, and cardiovascular disease and mortality is well established, however, the causal effect of weight-loss in midlife on these outcomes is less clear. Bariatric surgery results in substantial weight-loss and is an ideal candidate to study the causal effects of weight-loss. The investigators propose a project that will use causal inference and machine learning methods to answer two important questions:

  1. Is bariatric surgery effective for reducing cardiovascular disease and mortality, and if so, for who?
  2. Which type of bariatric surgery (gastric bypass or sleeve gastrectomy) is most effective, and for who? The investigators will use data from various Swedish registers to identify individuals with obesity who are eligible for bariatric surgery. We will then compare cardiovascular and mortality outcomes among those undergoing different types of bariatric surgery with those receiving non-surgical obesity management using causal inference methods. The investigators will use causal forests and expert knowledge to estimate indiviual treatment effects, and identify the groups of patients who benefit the most from these surgeries.
Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
December 31, 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Conor Macdonald

Dr.

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

  • Men and women of reproductive age with a diagnosis of obesity, no prior history of cardiovascular disease or cancer, and no contraindications for surgery after 1982

Exclusion Criteria

  • Contraindications to bariatric surgery

Outcomes

Primary Outcomes

Cardiovascular disease

Time Frame: 20 year

myocardial infarction, stroke, and death from cardiovascular causes

Secondary Outcomes

  • Death from any cause(20 year)

Study Sites (1)

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