Endoscopic Sleeve Gastroplasty for Obesity and Microbiota Randomized Trial
- Conditions
- Endoscopic Sleeve GastroplastyGastric MotilityGastric HormonesMicrobiotaQuality of LifeObesity
- Interventions
- Device: Endoscopic sleeve gastroplasty
- Registration Number
- NCT04200144
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
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
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard medical therapy control diet group Endoscopic sleeve gastroplasty Patients that will undergo diet active endoscopic treatment Endoscopic sleeve gastroplasty Patients that will undergo Endoscopic Sleeve Gastroplasty
- Primary Outcome Measures
Name Time Method Total body weight loss 36 months Total body weight loss (%) measurement in kg and BMI
- Secondary Outcome Measures
Name Time Method Non-Alcoholic Fatty Liver Disease evaluation 12 months Non-Alcoholic Fatty Liver Disease
performing of gastric emptying scintigraphy for gastrointestinal motility Baseline and six months Gastrointestinal motility evaluation
Non- Alcoholic-Steato-Hepatitis evaluation 12 months Non- Alcoholic-Steato-Hepatitis
Gut microbiota characterization 6 months Gut microbiota
Evaluation for Gastroesophageal reflux disease 12, 24, 36 months Gastroesophageal reflux disease
Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin dosages Baseline and 6 months Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin
Trial Locations
- Locations (1)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
🇮🇹Rome, Italy