Endoscopic Sleeve Gastroplasty for Obesity and Microbiota Randomized Trial

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Dec 13, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating a procedure called Endoscopic Sleeve Gastroplasty (ESG), which aims to help people with obesity lose weight and improve their overall health. The trial will compare the effects of this procedure to standard medical treatments for obesity over a period of 36 months. Researchers want to see how ESG impacts weight loss, health factors like cholesterol and blood sugar levels, quality of life, and changes in gut bacteria, which can affect digestion and appetite.

To participate in this trial, individuals need to be between the ages of 20 and 65, have a body mass index (BMI) between 30 and 45, and be willing to follow the study guidelines. Some people may not qualify if they have certain health issues, like active stomach ulcers or a history of specific surgeries. Those who participate can expect regular follow-ups and assessments to monitor their progress and health outcomes throughout the study. Additionally, if participants in the standard treatment group do not see adequate weight loss after six months, they will have the chance to receive the ESG procedure.

Gender

ALL

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