Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07576777

Hormonal and Microbiota Modulation After Endoscopic Sleeve Gastroplasty

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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).

Official title: Roles of Hormonal Modulation and the Microbiota in Gastric Emptying and Metabolic Response After Endoscopic Sleeve Gastroplasty

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-05-04

Completion Date

2029-05-04

Last Updated

2026-05-08

Healthy Volunteers

Conditions

Obesity (Disorder)Metabolic Disorders

Interventions

PROCEDURE

Laparoscopic sleeve gastrectomy

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

PROCEDURE

Endoscopic sleeve gastroplasty

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

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)

Locations (1)

Bichat hospital

Paris, Paris, France