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

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

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

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Obesity; Microbiota; Endoscopic Sleeve Gastroplasty; Gastric Motility; Gastric Hormones
• Intervention / Treatment: Device: Endoscopic sleeve gastroplasty

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ivo Boskoski, MD, PhD; Phone Number: +390630156580; Email: ivo.boskoski@policlinicogemelli.it

Study Locations

• Italy
  • Rome, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Contact: Ivo Boskoski, MD, PhD; Phone Number: 00390630156580; Email: ivo.boskoski@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2020
• Primary Completion (Actual): December 2, 2020
• Study Completion (Estimated): December 2, 2025

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: December 13, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 2837

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No