Obesity, MorbidMIMSNCT06346145
Impact of Bariatric Surgery on Heart Disease Compared to Standard Care
A study testing Bariatric surgery in people with Obesity, Morbid and Bariatric Surgery Candidate, run by Danderyd Hospital.
Trial summary
Obesity is associated with type 2 diabetes (T2D) and cardiovascular disease (CVD). Metabolic and bariatric surgery (MBS) has in several randomized controlled trials (RCT) been shown to be superior to best medical therapy in the treatment of T2D. In the area of CVD, RCT after MBS are lacking. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Morbid, Bariatric Surgery Candidate, Heart Diseases
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 May 2030
- Phase
- Interventional
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MI (as defined by the universal definition of MI) at least 1 year before inclusion.
- BMI ≥35 kg/m2
- Written informed consent obtained
Who cannot join
- Any condition that may influence the patient's ability to comply with study protocol.
- Earlier MBS or operation for gastric or duodenal ulcer or reflux disease
- Other condition that makes patient not suitable for MBS according to responsible surgeon and anesthesiologist
- Unable to understand Swedish.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Trial Comparing Metabolic Surgery to Standard Care in Patients With Severe Obesity and Established Cardiovascular Disease
Obesity is associated with type 2 diabetes (T2D) and cardiovascular disease (CVD). Metabolic and bariatric surgery (MBS) has in several randomized controlled trials (RCT) been shown to be superior to best medical therapy in the treatment of T2D. In the area of CVD, RCT after MBS are lacking. It was recently demonstrated in a cohort study that MBS in patients with severe obesity and a previous myocardial infarction (MI) was associated with a 50% reduction in the risk of death and new MI. The aim of this proposal is to confirm this in a nationwide RCT. Using the nationwide SWEDEHEART database patients with severe obesity and a previous MI will be identified. They will be contacted and offered participation. After informed consent the patients will be randomized to MBS or optimized care (including visit with a cardiologist and optimization of secondary preventive measures and referral to dietician/physiotherapist). The primary outcome measure is a major cardiovascular adverse event (MACE). Secondary outcome measures include mortality, new MI, stroke, heart failure and atrial fibrillation. Tertiary outcome measures include health related quality of life and surgical complications. Patients will be followed in the nationwide metabolic surgery register SOReg, the national inpatient register, national cause of death register, the Swedish prescribed drug register, and the Swedish population register. If positive results these can be included in guidelines for MBS.
- Conditions
- Obesity, Morbid, Bariatric Surgery Candidate, Heart Diseases
- Being tested
- Bariatric surgery, Standard care
- Medical subject headings
- Obesity, Morbid, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Type of surgery assigned by surgeon in consultation with patient
Standard careProcedure or surgery
Standard care can consist of dietary intervention, physiotherapy or drug treatment in accordance to the care given in the region of Sweden where the patient resides.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery | Active comparator | Gastric bypass or gastric sleeve Receives: Procedure: Bariatric surgery |
| Standard care | Active comparator | Standard obesity treatment offered in Swedish regions Receives: Procedure: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE defined as first occurrence of death (all-cause mortality), MI, stroke, myocardial revascularization (not related to MI), hospital admission because of heart failure or atrial fibrillation as a primary ICD diagnosis.
Data will be obtained for the Swedish national patient registry and other national quality registries.
Measured: Through study completion, expected average of 6 years
Secondary outcomes (9)
Total event rate
Based on events listed in the primary outcome measure. Data will be obtained for the Swedish national patient registry and other national quality registries.
Measured: Through study completion, expected average of 6 years
All-cause mortality
Data will be obtained for the Swedish national national quality registries.
Measured: Through study completion, expected average of 6 years
Cardiovascular death
Data will be obtained for the Swedish national national quality registries.
Measured: Through study completion, expected average of 6 years
Remission of type 2 diabetes (T2D) and hypertension
Number of patients in remission
Measured: Through study completion, expected average of 6 years
Myocardial infarction
Data will be obtained for the Swedish national national quality registries.
Measured: Through study completion, expected average of 6 years
Stroke
Data will be obtained for the Swedish national national quality registries.
Measured: Through study completion, expected average of 6 years
Myocardial revascularization (not related to MI)
Data will be obtained for the Swedish national national quality registries.
Measured: Through study completion, expected average of 6 years
hospital admission because of heart failure as a primary ICD diagnosis.
Data will be obtained for the Swedish national national quality registries.
Measured: Through study completion, expected average of 6 years
hospital admission because of atrial fibrillation as a primary ICD diagnosis.
Data will be obtained for the Swedish national national quality registries.
Measured: Through study completion, expected average of 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, The 21 healthcare regions in Sweden
- Responsible party
- Principal investigator, Erik Näslund, Danderyd Hospital
- Investigators
- Erik Näslund, MD, PhD, Principal investigator, Karolinska Institutet/Danderyd hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346145
- Sponsor's protocol ID
- MIMS study
- Other IDs
- 2023-00453, 2023
- Acronym
- MIMS
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared openly at a repository since it contains personal data. Data will be made available upon request after ensuring compliance with relevant legislation and Karolinska Institutet guidelines.
Publications
Naslund E, Stenberg E, Hofmann R, Ottosson J, Sundbom M, Marsk R, Svensson P, Szummer K, Jernberg T. Association of Metabolic Surgery With Major Adverse Cardiovascular Outcomes in Patients With Previous Myocardial Infarction and Severe Obesity: A Nationwide Cohort Study. Circulation. 2021 Apr 13;143(15):1458-1467. doi: 10.1161/CIRCULATIONAHA.120.048585. Epub 2020 Oct 26.
PubMed 33103469