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

Primary Purpose

Obesity, Endoscopic Sleeve Gastroplasty, Gastric Motility

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Endoscopic sleeve gastroplasty
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

active endoscopic treatment

standard medical therapy control diet group

Arm Description

Patients that will undergo Endoscopic Sleeve Gastroplasty

Patients that will undergo diet

Outcomes

Primary Outcome Measures

Total body weight loss
Total body weight loss (%) measurement in kg and BMI
Total body weight loss
Total body weight loss (%) measurement in kg and BMI

Secondary Outcome Measures

Non-Alcoholic Fatty Liver Disease evaluation
Non-Alcoholic Fatty Liver Disease
Non- Alcoholic-Steato-Hepatitis evaluation
Non- Alcoholic-Steato-Hepatitis
Gut microbiota characterization
Gut microbiota
Evaluation for Gastroesophageal reflux disease
Gastroesophageal reflux disease
Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin dosages
Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin
performing of gastric emptying scintigraphy for gastrointestinal motility
Gastrointestinal motility evaluation

Full Information

First Posted
November 14, 2019
Last Updated
February 11, 2021
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT04200144
Brief Title
Endoscopic Sleeve Gastroplasty for Obesity and Microbiota Randomized Trial
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Recruiting
Study Start Date
February 4, 2020 (Actual)
Primary Completion Date
December 2, 2020 (Actual)
Study Completion Date
December 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Endoscopic Sleeve Gastroplasty, Gastric Motility, Gastric Hormones, Microbiota, Quality of Life

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active endoscopic treatment
Arm Type
Active Comparator
Arm Description
Patients that will undergo Endoscopic Sleeve Gastroplasty
Arm Title
standard medical therapy control diet group
Arm Type
Active Comparator
Arm Description
Patients that will undergo diet
Intervention Type
Device
Intervention Name(s)
Endoscopic sleeve gastroplasty
Intervention Description
Endoscopic sleeve gastroplasty with Overstitch (Apollo Endosurgery)
Primary Outcome Measure Information:
Title
Total body weight loss
Description
Total body weight loss (%) measurement in kg and BMI
Time Frame
12 months
Title
Total body weight loss
Description
Total body weight loss (%) measurement in kg and BMI
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Non-Alcoholic Fatty Liver Disease evaluation
Description
Non-Alcoholic Fatty Liver Disease
Time Frame
12 months
Title
Non- Alcoholic-Steato-Hepatitis evaluation
Description
Non- Alcoholic-Steato-Hepatitis
Time Frame
12 months
Title
Gut microbiota characterization
Description
Gut microbiota
Time Frame
6 months
Title
Evaluation for Gastroesophageal reflux disease
Description
Gastroesophageal reflux disease
Time Frame
12, 24, 36 months
Title
Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin dosages
Description
Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin
Time Frame
Baseline and 6 months
Title
performing of gastric emptying scintigraphy for gastrointestinal motility
Description
Gastrointestinal motility evaluation
Time Frame
Baseline and six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivo Boskoski, MD, PhD
Phone
+390630156580
Email
ivo.boskoski@policlinicogemelli.it
Facility Information:
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivo Boskoski, MD, PhD
Phone
00390630156580
Email
ivo.boskoski@policlinicogemelli.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Endoscopic Sleeve Gastroplasty for Obesity and Microbiota Randomized Trial

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