This is an interventional, open-label, randomized (2:1), standard medical therapy-controlled trial. Subjects in the standard therapy group will be given the opportunity to undergo the active endoscopic treatment after 6 months of follow up (open label extension) if they will not achieve an adequate result on body weight. All patients will be followed until the planned end of the study after 36 months from the ESG procedure. To study the effects of endoscopic gastroplasty on weight, metabolic risk factors, quality of life, satiety, gastrointestinal motility and gut microbiota compared to standard medical treatment control group. Primary endpoint: \- Total body weight loss (%) Secondary endpoints: * Metabolic risk factors (e.g. lipid profile) and anthropometric measurements (e.g hip and waist circumference) * Body composition * Quality of life * Gastroesophageal reflux disease * Non-Alcoholic Fatty Liver Disease (NAFLD) * Non- Alcoholic-Steato-Hepatitis (NASH) * Satiety * Gut microbiota Exploratory endpoints: * Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin * Gastrointestinal motility
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
60
Endoscopic sleeve gastroplasty with Overstitch (Apollo Endosurgery)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
RECRUITINGTotal body weight loss
Total body weight loss (%) measurement in kg and BMI
Time frame: 12 months
Total body weight loss
Total body weight loss (%) measurement in kg and BMI
Time frame: 36 months
Non-Alcoholic Fatty Liver Disease evaluation
Non-Alcoholic Fatty Liver Disease
Time frame: 12 months
Non- Alcoholic-Steato-Hepatitis evaluation
Non- Alcoholic-Steato-Hepatitis
Time frame: 12 months
Gut microbiota characterization
Gut microbiota
Time frame: 6 months
Evaluation for Gastroesophageal reflux disease
Gastroesophageal reflux disease
Time frame: 12, 24, 36 months
Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin dosages
Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin
Time frame: Baseline and 6 months
performing of gastric emptying scintigraphy for gastrointestinal motility
Gastrointestinal motility evaluation
Time frame: Baseline and six months
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