Endoscopic Sleeve Gastroplasty, Gastric Hormones, Gastric Motility, Microbiota, Obesity, Quality of Life
Conditions
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
Interventions
Endoscopic sleeve gastroplasty with Overstitch (Apollo Endosurgery)
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total body weight loss | 12 months | Total body weight loss (%) measurement in kg and BMI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non- Alcoholic-Steato-Hepatitis evaluation | 12 months | Non- Alcoholic-Steato-Hepatitis |
| Gut microbiota characterization | 6 months | Gut microbiota |
| Non-Alcoholic Fatty Liver Disease evaluation | 12 months | Non-Alcoholic Fatty Liver 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 |
| performing of gastric emptying scintigraphy for gastrointestinal motility | Baseline and six months | Gastrointestinal motility evaluation |
| Evaluation for Gastroesophageal reflux disease | 12, 24, 36 months | Gastroesophageal reflux disease |
Countries
Italy
Contacts
Primary ContactIvo Boskoski, MD, PhD
Outcome results
None listed