Hormonal and Microbiota Modulation After Endoscopic Sleeve Gastroplasty

NCT07576777 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Not applicable

Started

2026-05-04

Last updated

2026-05-08

Condition(s) studied

Obesity (Disorder)Metabolic Disorders

Investigational drug(s) / intervention(s)

Laparoscopic sleeve gastrectomyEndoscopic sleeve gastroplasty

Laparoscopic sleeve gastrectomy: Participants undergo laparoscopic sleeve gastrectomy with 12-month follow-up including clinical, metabolic, imaging, hormonal and microbiota assessments.

Endoscopic sleeve gastroplasty: Participants undergo endoscopic sleeve gastrectomy with 12-month follow-up including clinical, metabolic, imaging, hormonal and microbiota assessments.

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 * Patient with an indication to undergo CT scan and scintigraphy * Written informed consent * Affiliation with a health insurance system Exclusion Criteria: * 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 * Presence of a hiatal hernia \> 2 cm * Contraindication to general anesthesia, including: * Severe coagulation disorders, including uncontrolled congenital or acquired hemostasis disorders, severe thrombocytopenia (platelets \< 50 G/L), non-interruptible anticoagulant or antiplatelet therapy according to current guidelines, uncorrected INR \> 1.5 * Hemodynamic instability, defined as persistent hypotension or shock, uncontrolled cardiac arrhythmias, or need for vasopressor support * Decompensated cardiac disease, including uncontrolled heart failure (NYHA III-IV), unstable ischemic heart disease or recent acute coronary syndrome, untreated severe valvular disease, uncontrolled severe hypertension * Decompensated respiratory disease, including acute or severe chronic respiratory failure not stabilized, uncontrolled severe COPD, untreated severe obstructive sleep apnea, persistent hypoxemia requiring high-flow oxygen therapy * Any other clinical condition considered incompatible with general anesthesia or endoscopy by the anesthesiologist or investigator, according to current guidelines and patient safety considerations Significant or unstable renal insufficiency, or history of severe reaction to iodinated contrast agents * Participation in another clinical research study, except for non-interventional studies * Patient under legal protection (guardianship, curatorship, or judicial protection) * Physical inability to provide written informed consent * Rare forms of obesity of genetic and/or central origin (e.g., associated with craniopharyngioma) * Pregnancy or breastfeeding * State medical aid (AME)

Primary outcome measure(s)

Gastric emptying evolution after endoscopic sleeve gastroplasty versus surgical sleeve — Baseline to 12 months post-intervention
Assessment of gastric emptying using scintigraphic measurement to compare physiological changes induced by endoscopic sleeve gastroplasty versus surgical sleeve.

Trial sites (1)

Facility	City	Region	Status
Bichat hospital	Paris	Paris

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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 NCT07576777 on ClinicalTrials.gov ↗ ← All trials in France