Bariatric Surgery CandidateNCT06420479
The Causal Effect of Bariatric Surgery on Cardiovascular Disease and Mortality
An observational study of Bariatric Surgery Candidate and Cardiovascular Diseases, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate, Cardiovascular Diseases, Morality
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2024to 31 Dec 2027
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A cohort of individuals eligible for bariatric surgery in Sweden
Who may be able to join
- 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
Who cannot join
- Contraindications to bariatric surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Stockholm
Conor MacDonald, PhD, 0000 ext. 000, conor.macdonald@ki.se
Anita Berglund, PhD, 0000 ext. 000, anita.berglund@ki.se
About this study
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:
- Is bariatric surgery effective for reducing cardiovascular disease and mortality, and if so, for who?
- 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.
- Being tested
- Bariatric surgery
- Keywords
- bariatric surgery, Cardiovascular Diseases, Mortality
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
A well-known intervention known to induce substantial weight loss
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular disease
myocardial infarction, stroke, and death from cardiovascular causes
Measured: 20 year
Secondary outcomes (1)
Death from any cause
Measured: 20 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Conor Macdonald, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420479
- Sponsor's protocol ID
- 2024-00558-01
- Status last verified
- Jun 2024
- First submitted
- 14 May 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Causal Effect of Bariatric Surgery on Cardiovascular Disease and Mortality
- ClinicalTrials.gov ID
- NCT06420479
- Acronym / sponsor ID
- 2024-00558-01
- Keywords
- bariatric surgery, Cardiovascular Diseases, Mortality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is bariatric surgery effective for reducing cardiovascular disease and mortality, and if so, for who?
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of individuals eligible for bariatric surgery in Sweden
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Contraindications to bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgeryA well-known intervention known to induce substantial weight loss | Procedure or surgery | – |
Primary outcome
Cardiovascular disease
Time frame: 20 year
myocardial infarction, stroke, and death from cardiovascular causes
1 secondary outcome
Death from any cause
Time frame: 20 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate and Cardiovascular Diseases, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Conor MacDonald, PhD (0000 ext. 000, conor.macdonald@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular disease (time frame: 20 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.