Endoscopic Sleeve Gastroplasty for Obesity and Microbiota Randomized Trial

NCT ID: NCT04200144

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-04
• Study Completion Date: 2025-12-02

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

active endoscopic treatment

Patients that will undergo Endoscopic Sleeve Gastroplasty

Group Type: ACTIVE_COMPARATOR

Endoscopic sleeve gastroplasty

Intervention Type: DEVICE

Endoscopic sleeve gastroplasty with Overstitch (Apollo Endosurgery)

standard medical therapy control diet group

Patients that will undergo diet

Group Type: ACTIVE_COMPARATOR

Endoscopic sleeve gastroplasty

Intervention Type: DEVICE

Endoscopic sleeve gastroplasty with Overstitch (Apollo Endosurgery)

Interventions

Endoscopic sleeve gastroplasty

Endoscopic sleeve gastroplasty with Overstitch (Apollo Endosurgery)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

BOSKOSKI IVO

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Ivo Boskoski, MD, PhD

Role: CONTACT

ivo.boskoski@policlinicogemelli.it

+390630156580

Facility Contacts

Ivo Boskoski, MD, PhD

Role: primary

ivo.boskoski@policlinicogemelli.it

00390630156580

Other Identifiers

2837

Identifier Type: -

Identifier Source: org_study_id