Identification of Factors Predictive of the Efficacy of Endoscopic Endoscopic Sleeve Gastroplasty

Not yet recruiting

• Conditions: Obesity

• Registration Number: NCT06153056
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

Inclusion Criteria:<br><br> - Patient of legal age (Age = 18 years)<br><br> - Patient capable of understanding the study and signing a consent.<br><br> - BMI between 30 and 35 kg/m² with the presence of at least one one obesity-related<br> complication (diabetes, dyslipidemia, sleep apnea syndrome, non-alcoholic<br> steatohepatitis, joint pain joint pain).<br><br> - Patients with a BMI greater than 35 kg/m² who have been bariatric surgery has been<br> refused.<br><br> - Patient who has failed to lose weight and improve with conventional techniques.<br><br> - Patient affiliated to a social security scheme<br><br>Exclusion Criteria:<br><br> - Patient having taken antibiotics 3 months prior to inclusion.<br><br> - Patient under legal protection.<br><br> - Patient at risk of gastric cancer requiring regular endoscopic surveillance:<br> extensive intestinal atrophy and/or metaplasia on biopsy.<br><br> - Patient with a history of gastrointestinal inflammatory disease of gastric<br> localization, hepatic or renal insufficiency, portal hypertension.<br><br> - Patient with evidence of peptic ulcer disease and/or progressive peptic ulcer<br> disease.<br><br> - Patient with pathology affecting general health health and/or life expectancy.<br><br> - Patient with a history of bariatric surgery.<br><br> - Patient on AME

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum metabolite profile using widely targeted metabolomics according to weigh loss amount (less than 10% of total weight versus more than 10% of total weight loss at 12 months post-surgery)