RecruitingNot ApplicableNCT05531474

Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial

Sponsor

Population Health Research Institute

Enrollment

700 participants

Start Date

Nov 2, 2020

Study Type

INTERVENTIONAL

Conditions

Cardiovascular Complication Bariatric Surgery Candidate

Summary

The primary objective of this study is to evaluate if, in patients with severe obesity (body mass index (BMI) ≥30 kg/m2) and high-risk cardiovascular disease (CVD), bariatric surgery compared to medical weight management (MWM) safely reduces the risk of major cardiovascular events. The cost-effectiveness of bariatric surgery will also be examined. Separate sub-studies will be performed to examine the relationship between bariatric surgery and mental health and cognition (BRAVE-Mind), cardiac structure and function, genomics, proteomics and metabolomics.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Bariatric Surgery and a behavioral approach called Medical Weight Management for people with bariatric surgery candidate and cardiovascular complication. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBariatric Surgery

Bariatric surgery involves either gastric bypass, sleeve gastrectomy, or duodenal switch, performed at the discretion of the surgeon and according to local practice standards.

BEHAVIORALMedical Weight Management

The current standard medical practice for weight loss that is available at the local participating centre, reflecting the local standard of care