Hormonal and Microbiota Modulation After Endoscopic Sleeve Gastroplasty (NCT07576777) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Hormonal and Microbiota Modulation After Endoscopic Sleeve Gastroplasty
France40 participantsStarted 2026-05-04
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, uncontro…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gastric emptying evolution after endoscopic sleeve gastroplasty versus surgical sleeve
Timeframe: Baseline to 12 months post-intervention