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Recruiting Observational

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

NCT06153056 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-09-09
Last updated
2026-01-21

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

Bloed-, ontlasting- en speekselmonsters

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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) — Before endoscopic sleeve gastroplasty
    A volume of 50 µl of serum/plasma will be used for analysis of serum metabolites using widely targeted metabolomics mass spectrometry.

Trial sites (1)

FacilityCityRegionStatus
Hôpital Antoine Béclère Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06153056 on ClinicalTrials.gov ↗ ← All trials in France