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Clinical Trial Summary

It is a prospective randomized trial on 218 subjects, 109 for each arms. The purpose of this trial is to compare very low calorie diet and metabolic surgery induced weight loss and its maintenance.


Clinical Trial Description

Obesity is a leading public health issued associated with poor quality of life, morbidity and an increased mortality rate. Although metabolic surgery results in a greater weight loss when compared to non-surgical approaches, a low calorie diet associated with intensive maintenance session may be a valid alternative for weight loss. Since lifestyle interventions are safer and potentially more cost effective than metabolic surgery, this trial will test whether an intensive lifestyle intervention is as effective as metabolic surgery to induce weight loss and its maintenance. A total of 218 participants will be randomly assigned to metabolic surgery (109) or intensive lifestyle intervention (109). Clinical outcomes will be assessed at 25% reduction in Body Mass Index (BMI), at 12 months and 24 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04583683
Study type Interventional
Source Catholic University of the Sacred Heart
Contact
Status Active, not recruiting
Phase N/A
Start date September 30, 2020
Completion date September 30, 2022

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