Clinical trial NCT04200144: Endoscopic Sleeve Gastroplasty for Obesity and Microbiota Randomized Trial
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
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Endoscopic Sleeve Gastroplasty
Gastric Motility
Gastric Hormones
Microbiota
Quality of Life
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


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

Primary outcomes:
measure: Total body weight loss
timeFrame: 12 months
measure: Total body weight loss
timeFrame: 36 months
Secondary outcomes:
measure: Non-Alcoholic Fatty Liver Disease evaluation
timeFrame: 12 months
measure: Non- Alcoholic-Steato-Hepatitis evaluation
timeFrame: 12 months
measure: Gut microbiota characterization
timeFrame: 6 months
measure: Evaluation for Gastroesophageal reflux disease
timeFrame: 12, 24, 36 months
measure: Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin dosages
timeFrame: Baseline and 6 months
measure: performing of gastric emptying scintigraphy for gastrointestinal motility
timeFrame: Baseline and six months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References: