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Recruiting NCT06420479

The Causal Effect of Bariatric Surgery on Cardiovascular Disease and Mortality

Observational Bariatric Surgery Candidate Cardiovascular Diseases Morality

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bariatric surgery.
Who it may be relevant to
Registry conditions: Bariatric Surgery Candidate, Cardiovascular Diseases, Morality. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure Bariatric surgery
    A well-known intervention known to induce substantial weight loss

Primary outcome measures

  • Cardiovascular disease [Time frame: 20 year]
Secondary outcome measures (1)
  • Death from any cause [Time frame: 20 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Karolinska Institutet — Stockholm

Identifiers

NCT: NCT06420479 · 2024-00558-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗