Identification of Factors Predictive of the Efficacy of Endoscopic Endoscopic Sleeve Gastroplasty

The prevalence of obesity is increasing worldwide, and it is estimated that one quarter of the world's population will be overweight or obese by 2045. Obesity can lead to complications, including cardiovascular damage (myocardial ischemia and stroke), liver damage (non-alcoholic steatohepatitis and liver cancer), diabetes and extra-hepatic cancers. In this context, achievement of a significant long-term weight loss is of paramount importance to ameliorate patient outcome. Bariatric surgery is the most effective treatment for severe obesity and results in a significant long-term weight loss. However, bariatric surgery is restricted to patients with a BMI \>40 kg/m2 or \>35 kg/m2 with commodities (hypertension, diabetes, sleep apnoea, NASH). Therefore, the majority of obese patients do not benefit from this procedure. Recent advances in flexible endoluminal endoscopy now provide the tools for transoral endoscopic gastric volume reduction (ESG, endoscopic sleeve gastroplasty).

The gastric body is reduced by an endoscopic procedure involving suture plications. This minimally invasive method may be a good therapeutic option to obtain a significant weight reduction in patients with moderate obesity or those with severe obesity and no indication for bariatric surgery (BMI between 35 and 40 kg/m2 without commodities). In this context this study aims to identify predictive factors of weight loss following ESG and explore changes of metabolic parameters, metabolomic profiles and gut microbiota profiles. This is a retro-prospective cohort study including patients with moderate obesity undergoing ECG between March 2017 and September 2023. Clinical parameters (weight, high, BMI, weight fluctuations), serum metabolic parameters (standard lipid profile, lipoprotein levels, fasting plasma glucose, insulin levels, C-peptide levels, hemoglobin A1c) and liver function test parameters (standard biology, transient elastometry, Fibrotest®, Actitest®, abdominal ultrasound) are systematically collected for all patients before ESG and then at three- and twelve-month post-ESG. Samples of serum, plasma, stools and saliva are also systematically collected for research purpose before ESG and then at three- and twelve-month post-ESG. Each sample is stored at -80°C for subsequent analysis. Metabolomic/lipidomic analysis will be used to quantify metabolite and lipid species in serum/plasma samples. Metagenomic analysis will be used to characterise faecal and salivary microbiota profiles.

• Clinical parameters at baseline and then at 3 and 12 month post-intervention. [Срок оценки: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12]
• Basic serum lipid profile at baseline and then at 3 and 12 month post-intervention. [Срок оценки: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12]
• Glycated hemoglobin at baseline and then at 3 and 12 month post-intervention. [Срок оценки: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12]
• Insulin at baseline and then at 3 and 12 month post-intervention. [Срок оценки: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12]
• C peptide at baseline and then at 3 and 12 month post-intervention. [Срок оценки: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12]
• Ferritin at baseline and then at 3 and 12 month post-intervention. [Срок оценки: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12]
• Liver function test parameter Alanine transaminase (ALT) at baseline and then at 3 and 12 month post-intervention. [Срок оценки: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12]
• Liver function test parameter aspartate transaminase (AST) at baseline and then at 3 and 12 month post-intervention. [Срок оценки: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12]
• Liver function test parameter Gamma-glutamyltransferase (GGT) at baseline and then at 3 and 12 month post-intervention. [Срок оценки: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12]
• Liver function test parameter Alkaline phosphatase (ALP) at baseline and then at 3 and 12 month post-intervention. [Срок оценки: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12]
• Liver fibrosis assessed by transient elastometry at baseline and then at 3 and 12 month post-intervention [Срок оценки: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12]
• Liver steatosis assessed by controlled attenuation parameter (CAP) at baseline and then at 3 and 12 month post-intervention. [Срок оценки: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12]