Endoscopic Sleeve Gastroplasty for Obesity and Microbiota Randomized Trial

NCT04200144 | Recruiting DMC

• 1 other identifier: 2837
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Non-Alcoholic Fatty Liver Disease evaluation

  12 months

• Non- Alcoholic-Steato-Hepatitis evaluation

  12 months

• Gut microbiota characterization

  6 months

• Evaluation for Gastroesophageal reflux disease

  12, 24, 36 months

• Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin dosages

  Baseline and 6 months

Study Arms (2)

active endoscopic treatment

ACTIVE COMPARATOR

Patients that will undergo Endoscopic Sleeve Gastroplasty

Device: Endoscopic sleeve gastroplasty

standard medical therapy control diet group

ACTIVE COMPARATOR

Patients that will undergo diet

Device: Endoscopic sleeve gastroplasty

Interventions

Endoscopic sleeve gastroplasty DEVICE

Endoscopic sleeve gastroplasty with Overstitch (Apollo Endosurgery)

active endoscopic treatment; standard medical therapy control diet group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ivo Boskoski, MD, PhD

CONTACT

+390630156580; ivo.boskoski@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: December 16, 2019
• Study Start: February 4, 2020
• Primary Completion: December 2, 2020
• Study Completion: December 2, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

IT (1)