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

NCT ID: NCT06153056

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 205 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-09
• Study Completion Date: 2031-02-02

Brief Summary

Endoscopic sleeve gastroplasty and bypass are currently available for weight loss in obese patients who have failed nutritional management. Despite very low risks, these techniques remain invasive. What's more, the French National Authority for Health recommends this procedure for patients with a BMI above 35 kg/m² with associated co-morbidities, or above 40 kg/m². This excludes grade I obese patients (30 < BMI < 35) who have no effective means of losing weight. The hospital's hepato-gastroenterology and nutrition department has therefore implemented endoscopic sleeve gastroplasty to address this problem. As with other surgical techniques, there is heterogeneity heterogeneity in weight loss. The investigators therefore aim to identify factors predictive of the efficacy of this procedure in order to improve patient management of patients.

Detailed Description

The prevalence of obesity is increasing worldwide, and it is estimated that one quarter of the world's population will be overweight or obese by 2045. Obesity can lead to complications, including cardiovascular damage (myocardial ischemia and stroke), liver damage (non-alcoholic steatohepatitis and liver cancer), diabetes and extra-hepatic cancers. In this context, achievement of a significant long-term weight loss is of paramount importance to ameliorate patient outcome. Bariatric surgery is the most effective treatment for severe obesity and results in a significant long-term weight loss. However, bariatric surgery is restricted to patients with a BMI >40 kg/m2 or >35 kg/m2 with commodities (hypertension, diabetes, sleep apnoea, NASH). Therefore, the majority of obese patients do not benefit from this procedure. Recent advances in flexible endoluminal endoscopy now provide the tools for transoral endoscopic gastric volume reduction (ESG, endoscopic sleeve gastroplasty).

The gastric body is reduced by an endoscopic procedure involving suture plications. This minimally invasive method may be a good therapeutic option to obtain a significant weight reduction in patients with moderate obesity or those with severe obesity and no indication for bariatric surgery (BMI between 35 and 40 kg/m2 without commodities). In this context this study aims to identify predictive factors of weight loss following ESG and explore changes of metabolic parameters, metabolomic profiles and gut microbiota profiles. This is a retro-prospective cohort study including patients with moderate obesity undergoing ECG between March 2017 and September 2023. Clinical parameters (weight, high, BMI, weight fluctuations), serum metabolic parameters (standard lipid profile, lipoprotein levels, fasting plasma glucose, insulin levels, C-peptide levels, hemoglobin A1c) and liver function test parameters (standard biology, transient elastometry, Fibrotest®, Actitest®, abdominal ultrasound) are systematically collected for all patients before ESG and then at three- and twelve-month post-ESG. Samples of serum, plasma, stools and saliva are also systematically collected for research purpose before ESG and then at three- and twelve-month post-ESG. Each sample is stored at -80°C for subsequent analysis. Metabolomic/lipidomic analysis will be used to quantify metabolite and lipid species in serum/plasma samples. Metagenomic analysis will be used to characterise faecal and salivary microbiota profiles.

Conditions

Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Bloed-, ontlasting- en speekselmonsters

In addition, the blood collected (24 mL) will be used for the following analyses:

GLP-1, PYY, branched-chain amino acids, Adipokines, leptin, adiponectin Blood bile acid levels: total and detailed analyzed by HPLC MS/MS Serum microbiome profile Genome-wide association study.

The stool sample will be used to establish the :

Intestinal bile acid profile Intestinal microbiota profile Saliva sampling for oral microbiota profiling.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patient of legal age (Age ≥ 18 years)
• Patient capable of understanding the study and signing a consent.
• BMI between 30 and 35 kg/m² with the presence of at least one one obesity-related complication (diabetes, dyslipidemia, sleep apnea syndrome, non-alcoholic steatohepatitis, joint pain joint pain).
• Patients with a BMI greater than 35 kg/m² who have been bariatric surgery has been refused.
• Patient who has failed to lose weight and improve with conventional techniques.
• Patient affiliated to a social security scheme

Exclusion Criteria

• Patient having taken antibiotics 3 months prior to inclusion.
• Patient under legal protection.
• Patient at risk of gastric cancer requiring regular endoscopic surveillance: extensive intestinal atrophy and/or metaplasia on biopsy.
• Patient with a history of gastrointestinal inflammatory disease of gastric localization, hepatic or renal insufficiency, portal hypertension.
• Patient with evidence of peptic ulcer disease and/or progressive peptic ulcer disease.
• Patient with pathology affecting general health health and/or life expectancy.
• Patient with a history of bariatric surgery.
• Patient on AME

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cosmin VOICAN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

APHP, Antoine-Béclère Hospital

Locations

Hôpital Antoine Béclère

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Cosmin VOICAN, MD, PhD

Role: CONTACT

cosmin.voican@aphp.fr

1 45 37 47 75 ext. +33

Gabriel PERLEMUTER, MD, PhD

Role: CONTACT

gabriel.perlemuter@aphp.fr

1 45 37 47 75 ext. +33

Facility Contacts

Cosmin VOICAN, Doctor

Role: primary

cosmin.voican@aphp.fr

Other Identifiers

2023-A01226-39

Identifier Type: OTHER

Identifier Source: secondary_id

APHP230882

Identifier Type: -

Identifier Source: org_study_id