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NCT Number: NCT06420479

The Causal Effect of Bariatric Surgery on Cardiovascular Disease and Mortality

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

Procedure

A well-known intervention known to induce substantial weight loss

Primary outcomes

  1. Cardiovascular disease

    Time frame: 20 year

    myocardial infarction, stroke, and death from cardiovascular causes

Secondary outcomes

  1. Death from any cause

    Time frame: 20 year

Study contacts

Contact information is provided by the study sponsor or research team.

Anita Berglund, PhD

CONTACT

[email protected]

0000 ext. 000

Conor MacDonald, PhD

CONTACT

[email protected]

0000 ext. 000

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 20, 2024
Registry last updated
Jun 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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