Health TrialsbyHealthPanel

Hormonal and Microbiota Modulation After Endoscopic Sleeve Gastroplasty

ConditionsObesity (Disorder)Metabolic Disorders
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Laparoscopic sleeve gastrectomy

    Procedure/Surgery

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

  • Endoscopic sleeve gastroplasty

    Procedure/Surgery

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Laparoscopic sleeve gastrectomyOther 1 intervention
Group B: Endoscopic sleeve gastroplastyOther 1 intervention

Trial outcomes

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.

Time frame
Baseline to 12 months post-intervention

Secondary outcomes

1

Gastric microbiota diversity assessed by 16S rRNA sequencing

Gastric microbiota diversity assessed from gastric biopsies using 16S rRNA gene sequencing and expressed using the Shannon diversity index.

Time frame
Baseline to 12 months
2

Total Body Weight Loss (TBWL)

Total Body Weight Loss expressed as percentage (%) of initial body weight.

Time frame
Baseline, 1, 3, 6 and 12 months
3

Postprandial GLP-1 plasma concentration after standardized meal test

GLP-1 plasma concentrations measured at T0, T30, T90 and T180 following a standardized meal test. Results expressed in pmol/L.

Time frame
Baseline, 1, 3, 6 and 12 months
4

Correlation between gastric emptying and GLP-1 plasma levels

Correlation between gastric emptying assessed by scintigraphy (gastric half-emptying time in minutes) and GLP-1 plasma concentrations measured after a standardized meal test.

Time frame
Baseline to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: