Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04200144
Other study ID # 2837
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 4, 2020
Est. completion date December 2, 2025

Study information

Verified date February 2024
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Ivo Boskoski, MD, PhD
Phone +390630156580
Email ivo.boskoski@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2, 2025
Est. primary completion date December 2, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility 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

Study Design


Intervention

Device:
Endoscopic sleeve gastroplasty
Endoscopic sleeve gastroplasty with Overstitch (Apollo Endosurgery)

Locations

Country Name City State
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total body weight loss Total body weight loss (%) measurement in kg and BMI 12 months
Primary Total body weight loss Total body weight loss (%) measurement in kg and BMI 36 months
Secondary Non-Alcoholic Fatty Liver Disease evaluation Non-Alcoholic Fatty Liver Disease 12 months
Secondary Non- Alcoholic-Steato-Hepatitis evaluation Non- Alcoholic-Steato-Hepatitis 12 months
Secondary Gut microbiota characterization Gut microbiota 6 months
Secondary Evaluation for Gastroesophageal reflux disease Gastroesophageal reflux disease 12, 24, 36 months
Secondary Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin dosages Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin Baseline and 6 months
Secondary performing of gastric emptying scintigraphy for gastrointestinal motility Gastrointestinal motility evaluation Baseline and six months
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2