Endoscopic Sleeve Gastroplasty for Obesity and Microbiota Randomized Trial

Obesity Clinical Trial

— ESGORT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04200144
• Other study ID #: 2837
• Status: Recruiting
• Phase: N/A
• Start date: February 4, 2020
• Est. completion date: December 2, 2025

Study information

• Verified date: February 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Ivo Boskoski, MD, PhD
• Phone: +390630156580
• Email: ivo.boskoski[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2, 2025
• Est. primary completion date: December 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Endoscopic Sleeve Gastroplasty
• Gastric Hormones
• Gastric Motility
• Microbiota
• Obesity
• Quality of Life

Intervention

Device:
• Endoscopic sleeve gastroplasty
Endoscopic sleeve gastroplasty with Overstitch (Apollo Endosurgery)

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total body weight loss	Total body weight loss (%) measurement in kg and BMI	12 months
Primary	Total body weight loss	Total body weight loss (%) measurement in kg and BMI	36 months
Secondary	Non-Alcoholic Fatty Liver Disease evaluation	Non-Alcoholic Fatty Liver Disease	12 months
Secondary	Non- Alcoholic-Steato-Hepatitis evaluation	Non- Alcoholic-Steato-Hepatitis	12 months
Secondary	Gut microbiota characterization	Gut microbiota	6 months
Secondary	Evaluation for Gastroesophageal reflux disease	Gastroesophageal reflux disease	12, 24, 36 months
Secondary	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
Secondary	performing of gastric emptying scintigraphy for gastrointestinal motility	Gastrointestinal motility evaluation	Baseline and six months