An interventional study of Bariatric surgery and Standard care in Obesity, Morbid, Bariatric Surgery Candidate and Heart Diseases, sponsored by Danderyd Hospital. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by Danderyd Hospital · Not applicable, Interventional, and Treatment
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.
936 studies on the registry are indexed under Obesity, Morbid; 169 are open to participants now.
This study's planned enrollment of 500 is above the median of 60 across 599 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Danderyd Hospital is the lead sponsor of 60 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Gastric bypass or gastric sleeve
Procedure: Bariatric surgery
Standard obesity treatment offered in Swedish regions
Procedure: Standard care
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.
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.
Time frame: Through study completion, expected average of 6 years
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.
Time frame: Through study completion, expected average of 6 years
All-cause mortality
Data will be obtained for the Swedish national national quality registries.
Time frame: Through study completion, expected average of 6 years
Cardiovascular death
Data will be obtained for the Swedish national national quality registries.
Time frame: Through study completion, expected average of 6 years
Remission of type 2 diabetes (T2D) and hypertension
Number of patients in remission
Time frame: Through study completion, expected average of 6 years
Myocardial infarction
Data will be obtained for the Swedish national national quality registries.
Time frame: Through study completion, expected average of 6 years
Stroke
Data will be obtained for the Swedish national national quality registries.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, expected average of 6 years
Safety, i.e., no excess of severe complications (Clavien-Dindo ≥3b (a complication requiring intervention under general anesthesia or resulting in organ failure or death)) and long-term morbidity.
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
Body weight change
Change in kg from baseline during long-term follow-up.
Time frame: 5-year follow-up
Change in quality of life
Assessed by EQ-5D-5L questionnaire
Time frame: 5-year follow-up
All-cause hospitalizations
Based on ICD 10 diagnosis in national patient registry and other national quality registries
Time frame: Through study completion, expected average of 6 years
Change in quality of life
Assessed by RAND 36
Time frame: 5-year follow-up
No study locations are listed for this record.
Plan to share: 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.
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Danderyd Hospital