Hormonal and Microbiota Modulation After Endoscopic Sleeve Gastroplasty

NCT07576777 | Not Yet Recruiting

• 1 other identifier: APHP251929
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Obesity (Disorder); Metabolic Disorders

Keywords

Obesity; Endoscopic Sleeve Gastroplasty; Sleeve Gastrectomy; Gastric Emptying; Gut Hormones; Gastric Microbiota; Weight Loss; Metabolic Response

Outcome Measures

Primary Outcomes (1)

• Gastric emptying evolution after endoscopic sleeve gastroplasty versus surgical sleeve

  Assessment of gastric emptying using scintigraphic measurement to compare physiological changes induced by endoscopic sleeve gastroplasty versus surgical sleeve.

  Baseline to 12 months post-intervention

Secondary Outcomes (13)

• Gastric microbiota diversity assessed by 16S rRNA sequencing

  Baseline to 12 months

• Total Body Weight Loss (TBWL)

  Baseline, 1, 3, 6 and 12 months

• Postprandial GLP-1 plasma concentration after standardized meal test

  Baseline, 1, 3, 6 and 12 months

• Correlation between gastric emptying and GLP-1 plasma levels

  Baseline to 12 months

• Correlation between gastric emptying and PYY plasma levels

  Baseline to 12 months

Study Arms (2)

Laparoscopic sleeve gastrectomy

OTHER

Intervention assigned during a multidisciplinary team meeting (MDT).

Procedure: Laparoscopic sleeve gastrectomy

Endoscopic sleeve gastroplasty

OTHER

Intervention assigned during a multidisciplinary team meeting (MDT).

Procedure: Endoscopic sleeve gastroplasty

Interventions

Laparoscopic sleeve gastrectomy PROCEDURE

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

Laparoscopic sleeve gastrectomy

Endoscopic sleeve gastroplasty PROCEDURE

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

Endoscopic sleeve gastroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bichat hospital

Paris, Paris, 75018, France

Location

MeSH Terms

Conditions

Obesity; Metabolic Diseases; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Central Study Contacts

Maxime AMOYEL, DM

CONTACT

01 40 25 76 52; Maxime.amoyal@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective comparative study with two groups

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 8, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): December 4, 2028
• Study Completion (Estimated): May 4, 2029
• Last Updated: May 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)