Endoscopic Sleeve Gastroplasty for Obesity and Microbiota Randomized Trial

Study Overview
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Brief Summary
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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

Official Title
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An Open-label, Randomized, Controlled Clinical Trial on the Effects of Endoscopic Sleeve Gastroplasty on Weight, Metabolic Risk Factors, Quality of Life, Satiety, Gastrointestinal Motility and Gut Microbiota

Conditions
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Obesity, Endoscopic Sleeve Gastroplasty, Gastric Motility, Gastric Hormones, Microbiota, Quality of Life

Intervention / Treatment
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* Device: Endoscopic sleeve gastroplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active endoscopic treatment<br>Patients that will undergo Endoscopic Sleeve Gastroplasty | Device: Endoscopic sleeve gastroplasty<br>* Endoscopic sleeve gastroplasty with Overstitch (Apollo Endosurgery)<br>|
| Active Comparator: standard medical therapy control diet group<br>Patients that will undergo diet | Device: Endoscopic sleeve gastroplasty<br>* Endoscopic sleeve gastroplasty with Overstitch (Apollo Endosurgery)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total body weight loss | Total body weight loss (%) measurement in kg and BMI | 12 months | 
| Total body weight loss | Total body weight loss (%) measurement in kg and BMI | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-Alcoholic Fatty Liver Disease evaluation | Non-Alcoholic Fatty Liver Disease | 12 months | 
| Non- Alcoholic-Steato-Hepatitis evaluation | Non- Alcoholic-Steato-Hepatitis | 12 months | 
| Gut microbiota characterization | Gut microbiota | 6 months | 
| Evaluation for Gastroesophageal reflux disease | Gastroesophageal reflux disease | 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 | Baseline and 6 months | 
| performing of gastric emptying scintigraphy for gastrointestinal motility | Gastrointestinal motility evaluation | Baseline and six months |