The Causal Effect of Bariatric Surgery on Cardiovascular Disease and Mortality

NCT06420479 | Recruiting

• 1 other identifier: 2024-00558-01
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

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. 1.Is bariatric surgery effective for reducing cardiovascular disease and mortality, and if so, for who?
2. 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.

Conditions

Bariatric Surgery Candidate; Cardiovascular Diseases; Morality

Keywords

bariatric surgery; Cardiovascular Diseases; Mortality

Outcome Measures

Primary Outcomes (1)

• Cardiovascular disease

  myocardial infarction, stroke, and death from cardiovascular causes

  20 year

Secondary Outcomes (1)

• Death from any cause

  20 year

Interventions

Bariatric surgery PROCEDURE

A well-known intervention known to induce substantial weight loss

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A cohort of individuals eligible for bariatric surgery in Sweden

You may qualify if:

• 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

You may not qualify if:

• Contraindications to bariatric surgery

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Bariatric Surgery

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Conor MacDonald, PhD

CONTACT

0000; conor.macdonald@ki.se

Anita Berglund, PhD

CONTACT

0000; anita.berglund@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)