Effects of a Low-Energy Diet Compared with a Low-Energy Diet and Intragastric Balloon in Adults with Obesity, in Combination with Group Treatment: A Randomized Controlled Study

A randomized controlled study evaluating the added value of an intragastric balloon to low-energy diet treatment and cognitive behavioral therapy in patients with obesity. Primary outcomes include absolute weight loss and maintenance of weight loss. Secondary outcomes include effects on glucose metabolism and predictive factors related to balloon tolerability. Both psychometric and physiological parameters, as well as various biological parameters such as gut microbiota, proteins and lipids, hormones, and liver elastography, are collected to study and predict which patients will benefit the most from this treatment.