ESGORTEffects of Endoscopic Sleeve Gastroplasty on Weight, Metabolic Risk Factors, Quality of Life, Satiety, Gastrointestinal Motility and Gut Microbiota
This study aims to evaluate the impact of Endoscopic Sleeve Gastroplasty on your total body weight loss, measured in kg and BMI, as well as its effects on metabolic risk factors, quality of life, satiety, gastrointestinal motility, and gut microbiota.
Endoscopic sleeve gastroplasty
Body Weight+5
+ Nutrition Disorders
+ Nutritional and Metabolic Diseases
Basic Science Study
Summary
Study start date: February 4, 2020
Actual date on which the first participant was enrolled.This clinical trial aims to explore the effects of an endoscopic procedure called Endoscopic Sleeve Gastroplasty (ESG) in comparison to standard medical treatment. The study focuses on individuals who are managing their weight and related health factors. By comparing ESG to standard medical care, the trial seeks to understand if ESG can offer improved outcomes. The potential benefits could include enhanced weight loss, better management of metabolic risk factors, improved quality of life, increased feelings of fullness, and changes in gut bacteria and digestive system function. The study lasts for 36 months and includes an open-label extension where participants in the standard therapy group may opt for the ESG procedure if they do not achieve sufficient weight loss results after 6 months. During the study, participants in the ESG group undergo the endoscopic procedure, while those in the standard therapy group receive conventional medical care. The primary goal is to measure the total body weight loss percentage. Secondary goals include assessing changes in metabolic risk factors like cholesterol levels, body measurements, body composition, quality of life, gastroesophageal reflux disease, non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, feelings of fullness, and gut bacteria. Additionally, the study will explore changes in gut hormones and digestive system function. Participants who do not achieve significant weight loss results in the standard therapy group may have the option to undergo the ESG procedure after 6 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 20 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: The participants have to fulfill the following criteria for participating in the study: * Age 20 to 65 years * BMI between 30 to 45 kg/m2 * Willingness to participate in the study and ability to comply and understand the study protocol Exclusion Criteria: Active gastric ulcer during the last 6 months * Organic or motility disorder of the stomach and / or esophagus * Anticoagulant treatment * Previous bariatric surgery or any other type of surgery of the esophagus, stomach and duodenum * Ongoing or active malignancy during the last 5 years * Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification * Drug or alcohol abuse * Bulimic or binge eating pattern * Continuous glucocorticoid or anti-inflammatory treatment * Uncontrolled thyroid disease * Pregnancy, breastfeeding * Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study * Hiatal hernia \> 5 cm * Currently participating in other study * Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, ItalyOpen Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Google Maps