Clinical Trial

Hormonal and Microbiota Modulation After Endoscopic Sleeve Gastroplasty

Study acronym: HOVIGAMI-ESG
Not Yet Recruiting
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Summary
Obesity is a chronic disease with a rapidly increasing prevalence, expected to affect up to 25% of the French population by 2030, and is associated with significant morbidity, mortality, and healthcare burden. Bariatric surgery, including sleeve gastrectomy and gastric bypass, remains the standard treatment for severe obesity but is irreversible and carries procedural risks. Less invasive alternatives have emerged, including pharmacological treatments (GLP-1 receptor agonists and multi-agonists) and endoscopic approaches such as endoscopic sleeve gastroplasty (ESG), which have shown efficacy in weight loss and metabolic improvement, although drug therapies are limited by weight regain after discontinuation. Sleeve gastrectomy, the most frequently performed bariatric procedure in France, induces weight loss through gastric restriction and hormonal changes, including decreased ghrelin and increased GLP-1 and PYY, along with accelerated gastric emptying. ESG is a minimally invasive endoscopic technique with mechanisms that remain incompletely understood, likely involving gastric restriction, altered gastric emptying, and hormonal and microbiome-related effects. Bariatric outcomes are driven by complex interactions between gastric anatomy, motility, hormonal regulation, and the gut microbiome. An integrated evaluation of these parameters is needed to better understand response variability after intervention. A total of 40 patients will be enrolled (20 per group).
Trial Details
NCT Number NCT07576777
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Obesity (Disorder), Metabolic Disorders
Enrollment 40 participants
Start Date 2026-05-04
Primary Completion 2028-12-04 (estimated)
Study Completion 2029-05-04 (estimated)
Updated on ClinicalTrials.gov 2026-05-08