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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:
Exploratory endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active endoscopic treatment | Active Comparator | Patients that will undergo Endoscopic Sleeve Gastroplasty |
|
| standard medical therapy control diet group | Active Comparator | Patients that will undergo diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic sleeve gastroplasty | Device | Endoscopic sleeve gastroplasty with Overstitch (Apollo Endosurgery) |
|
| 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 |
| 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 |
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Inclusion Criteria:
The participants have to fulfill the following criteria for participating in the study:
Exclusion Criteria:
Active gastric ulcer during the last 6 months
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ivo Boskoski, MD, PhD | Contact | +390630156580 | ivo.boskoski@policlinicogemelli.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Rome | 00168 | Italy |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |