NCT06420479 The Causal Effect of Bariatric Surgery on Cardiovascular Disease and Mortality
| NCT ID | NCT06420479 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Bariatric Surgery Candidate |
| Study Type | OBSERVATIONAL |
| Enrollment | 100,000 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100,000 participants in total. It began in 2024-01-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06420479 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bariatric Surgery Candidate. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06420479 currently recruiting?
Yes, NCT06420479 is actively recruiting participants. Contact the research team at conor.macdonald@ki.se for enrollment information.
Where is the NCT06420479 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT06420479 clinical trial?
NCT06420479 is sponsored by Karolinska Institutet. The trial plans to enroll 100,000 participants.