Endoscopic Sleeve Gastroplasty for Obesity and Microbiota Randomized Trial (ESGORT)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

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

Treatments: Device: Endoscopic sleeve gastroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04200144

2837

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

active endoscopic treatment

Active Comparator group

Description:

Patients that will undergo Endoscopic Sleeve Gastroplasty

Treatment:

Device: Endoscopic sleeve gastroplasty

standard medical therapy control diet group

Active Comparator group

Description:

Patients that will undergo diet

Treatment:

Device: Endoscopic sleeve gastroplasty