Ignite Creation Date:
2024-05-06 @ 2:03 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04200144
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2019-11-14
Brief Title:
Endoscopic Sleeve Gastroplasty for Obesity and Microbiota Randomized Trial
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESGORT
Brief Summary:
This is an interventional open-label randomized 21 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 eg lipid profile and anthropometric measurements eg 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 eg glucagon-like peptide 1 PYY and ghrelin
Gastrointestinal motility
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 eg lipid profile and anthropometric measurements eg 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 eg glucagon-like peptide 1 PYY and ghrelin
Gastrointestinal motility
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None