The Causal Effect of Bariatric Surgery on Cardiovascular Disease and Mortality

NCT ID: NCT06420479

Last Updated: 2024-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bariatric Surgery Candidate Cardiovascular Diseases Morality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Bariatric surgery

A well-known intervention known to induce substantial weight loss

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Conor Macdonald

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Karolinska Institutet

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Conor MacDonald, PhD

Role: CONTACT

0000 ext. 000

Anita Berglund, PhD

Role: CONTACT

0000 ext. 000

Facility Contacts

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Conor MacDonald, PhD

Role: primary

0000 ext. 000

Anita Berglund, PhD

Role: backup

0000 ext. 000

Other Identifiers

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2024-00558-01

Identifier Type: -

Identifier Source: org_study_id

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