bariatric surgery
ProcedureType of surgery assigned by surgeon in consultation with patient
NCT Number: NCT06346145
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Type of surgery assigned by surgeon in consultation with patient
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.
Time frame: Through study completion, expected average of 6 years
Data will be obtained for the Swedish national patient registry and other national quality registries.
Time frame: Through study completion, expected average of 6 years
Based on events listed in the primary outcome measure. Data will be obtained for the Swedish national patient registry and other national quality registries.
Time frame: Through study completion, expected average of 6 years
Data will be obtained for the Swedish national national quality registries.
Time frame: Through study completion, expected average of 6 years
Data will be obtained for the Swedish national national quality registries.
Time frame: Through study completion, expected average of 6 years
Number of patients in remission
Time frame: Through study completion, expected average of 6 years
Data will be obtained for the Swedish national national quality registries.
Time frame: Through study completion, expected average of 6 years
Data will be obtained for the Swedish national national quality registries.
Time frame: Through study completion, expected average of 6 years
Data will be obtained for the Swedish national national quality registries.
Time frame: Through study completion, expected average of 6 years
Data will be obtained for the Swedish national national quality registries.
Time frame: Through study completion, expected average of 6 years
Data will be obtained for the Swedish national national quality registries.
Time frame: Through study completion, expected average of 6 years
Data will be obtained for the Swedish national patient registry and other national quality registries.
Time frame: 5-year follow-up
Change in kg from baseline during long-term follow-up.
Time frame: 5-year follow-up
Assessed by EQ-5D-5L questionnaire
Time frame: Through study completion, expected average of 6 years
Based on ICD 10 diagnosis in national patient registry and other national quality registries
Time frame: 5-year follow-up
Assessed by RAND 36
Contact information is provided by the study sponsor or research team.
Danderyd Hospital
Other
A Randomized Controlled Trial Comparing Metabolic Surgery to Standard Care in Patients With Severe Obesity and Established Cardiovascular Disease
Acronym: MIMS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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