Hormonal and Microbiota Modulation After Endoscopic Sleeve Gastroplasty

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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).

Eligibility criteria

Qualifiers

Male or female, age ≥ 18 years

BMI between 30 and 40 kg/m²

With or without obesity-related comorbidities (hypertension, diabetes, -obstructive sleep apnea, etc.)

Indication for ESG (Endoscopic Sleeve Gastroplasty) or surgical sleeve gastrectomy validated in a multidisciplinary team meeting

Disqualifiers

Patient receiving anti-obesity treatment (GLP-1 analogs, multi-agonists)

History of prior gastric surgery

History of gastric or distal esophageal cancer

History of gastric dysplasia

Trial design

Treatments tested in this trial

  • Laparoscopic sleeve gastrectomy
  • Endoscopic sleeve gastroplasty

Treatment groups

40 Participants
are divided into 2 treatment groups