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Endoscopic Sleeve Gastroplasty for Obesity and Microbiota Randomized Trial

NCT04200144 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-02-28

No results posted yet for this study

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

Interventions

DEVICE

Endoscopic sleeve gastroplasty

Endoscopic sleeve gastroplasty with Overstitch (Apollo Endosurgery)

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-04
Primary Completion
2020-12-02
Completion
2025-12-02

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04200144 on ClinicalTrials.gov