The Causal Effect of Bariatric Surgery on Cardiovascular Disease and Mortality

Cardiovascular Diseases Clinical Trial

Official title:

The Causal Effect of Bariatric Surgery on Cardiovascular Disease and Mortality

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06420479
• Other study ID #: 2024-00558-01
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: June 2024
• Source: Karolinska Institutet
• Contact: Conor MacDonald, PhD
• Phone: 0000
• Email: conor.macdonald[@]ki.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Cardiovascular Diseases
• Morality

Intervention

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

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular disease	myocardial infarction, stroke, and death from cardiovascular causes	20 year
Secondary	Death from any cause		20 year