Hormonal and Microbiota Modulation After Endoscopic Sleeve Gastroplasty (HOVIGAMI-ESG)
Roles of Hormonal Modulation and the Microbiota in Gastric Emptying and Metabolic Response After Endoscopic Sleeve Gastroplasty
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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Obesity is a chronic disease with increasing prevalence, projected 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 reference treatment for severe obesity but is irreversible and associated with procedural risks.
Less invasive alternatives have emerged, including pharmacological treatments (GLP-1 receptor agonists and multi-agonists) and endoscopic procedures such as endoscopic sleeve gastroplasty (ESG). These approaches have demonstrated efficacy in weight loss and metabolic improvement, although pharmacological treatments are limited by weight regain after discontinuation and reduced long-term adherence.
Sleeve gastrectomy, the most commonly performed bariatric procedure in France, induces weight loss through gastric restriction, hormonal changes (including reduced ghrelin and increased GLP-1 and PYY), and accelerated gastric emptying. In contrast, ESG is a minimally invasive endoscopic technique with mechanisms that remain incompletely understood, with emerging data suggesting delayed gastric emptying.
Beyond mechanical restriction, the metabolic effects of bariatric interventions involve complex interactions between gastric anatomy, motility, gut hormones, and the microbiome. Gastric emptying, a key determinant of satiety and hormonal response, differs between procedures and may contribute to variability in weight loss outcomes. Hormonal adaptations and microbiome changes after ESG remain insufficiently characterized.
This study adopts an integrative approach combining gastric volumetry, gastric emptying assessment, hormonal profiling, and microbiome analysis to better understand mechanisms of response and inter-individual variability after bariatric interventions.
A total of 40 patients will be enrolled (20 per group), with treatment allocation determined by a multidisciplinary team. Participants will undergo serial assessments including blood sampling, standardized meal test hormone measurements, CT-based gastric volumetry, and gastric emptying scintigraphy. Endoscopic biopsies will be performed at 12 months in the ESG group, while gastroscopy in the surgical group will be performed only if clinically indicated.
The study aims to improve mechanistic understanding of bariatric interventions, identify predictors of response, and support personalized therapeutic strategies in obesity management.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Maxime AMOYEL, DM
- Número de teléfono: 01 40 25 76 52
- Correo electrónico: Maxime.amoyal@aphp.fr
Ubicaciones de estudio
-
-
Paris
-
Paris, Paris, Francia, 75018
- Bichat Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Laparoscopic sleeve gastrectomy
Intervention assigned during a multidisciplinary team meeting (MDT).
|
Participants undergo laparoscopic sleeve gastrectomy with 12-month follow-up including clinical, metabolic, imaging, hormonal and microbiota assessments.
|
|
Otro: Endoscopic sleeve gastroplasty
Intervention assigned during a multidisciplinary team meeting (MDT).
|
Participants undergo endoscopic sleeve gastrectomy with 12-month follow-up including clinical, metabolic, imaging, hormonal and microbiota assessments.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Gastric emptying evolution after endoscopic sleeve gastroplasty versus surgical sleeve
Periodo de tiempo: 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.
|
Baseline to 12 months post-intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Gastric microbiota diversity assessed by 16S rRNA sequencing
Periodo de tiempo: Baseline to 12 months
|
Gastric microbiota diversity assessed from gastric biopsies using 16S rRNA gene sequencing and expressed using the Shannon diversity index.
|
Baseline to 12 months
|
|
Total Body Weight Loss (TBWL)
Periodo de tiempo: Baseline, 1, 3, 6 and 12 months
|
Total Body Weight Loss expressed as percentage (%) of initial body weight.
|
Baseline, 1, 3, 6 and 12 months
|
|
Postprandial GLP-1 plasma concentration after standardized meal test
Periodo de tiempo: Baseline, 1, 3, 6 and 12 months
|
GLP-1 plasma concentrations measured at T0, T30, T90 and T180 following a standardized meal test.
Results expressed in pmol/L.
|
Baseline, 1, 3, 6 and 12 months
|
|
Correlation between gastric emptying and GLP-1 plasma levels
Periodo de tiempo: Baseline to 12 months
|
Correlation between gastric emptying assessed by scintigraphy (gastric half-emptying time in minutes) and GLP-1 plasma concentrations measured after a standardized meal test.
|
Baseline to 12 months
|
|
Correlation between gastric emptying and PYY plasma levels
Periodo de tiempo: Baseline to 12 months
|
Correlation between gastric emptying assessed by scintigraphy (gastric half-emptying time in minutes) and PYY plasma concentrations measured after a standardized meal test.
|
Baseline to 12 months
|
|
Correlation between gastric emptying and GIP plasma levels
Periodo de tiempo: Baseline to 12 months
|
Correlation between gastric emptying assessed by scintigraphy (gastric half-emptying time in minutes) and GIP plasma concentrations measured after a standardized meal test.
|
Baseline to 12 months
|
|
Correlation between gastric emptying and ghrelin plasma levels
Periodo de tiempo: Baseline to 12 months
|
Correlation between gastric emptying assessed by scintigraphy (gastric half-emptying time in minutes) and ghrelin plasma concentrations measured after a standardized meal test
|
Baseline to 12 months
|
|
Gastric volume assessed by CT-based volumetry
Periodo de tiempo: Baseline, 1 month and 12 months
|
Measurement of gastric volume using CT scan (gastroscanner) with volumetric reconstruction.
Results expressed in milliliters (mL).
|
Baseline, 1 month and 12 months
|
|
Effect of gastric emptying time on total body weight loss
Periodo de tiempo: Baseline to 12 months
|
Total body weight loss (%), analyzed according to gastric half-emptying time (minutes) assessed by gastric scintigraphy using linear regression.
|
Baseline to 12 months
|
|
Effect of postprandial GLP-1 plasma concentration on total body weight loss
Periodo de tiempo: Baseline to 12 months
|
Total body weight loss (%), analyzed according to plasma GLP-1 concentration (pmol/L) measured after a standardized meal test using biochemical assay and linear regression.
|
Baseline to 12 months
|
|
Effect of gastric volume on total body weight loss
Periodo de tiempo: Baseline to 12 months
|
Total body weight loss (%), analyzed according to gastric volume (mL) measured by computed tomography (CT scan) using linear regression.
|
Baseline to 12 months
|
|
Effect of gastric microbiota diversity on total body weight loss
Periodo de tiempo: Baseline to 12 months
|
Total body weight loss (%), analyzed according to gastric microbiota diversity assessed using the Shannon diversity index derived from 16S rRNA gene sequencing using linear regression.
|
Baseline to 12 months
|
|
Safety and tolerability of endosleeve versus surgical sleeve
Periodo de tiempo: From intervention to 12 months
|
Incidence of adverse events including digestive, hemorrhagic, infectious, anesthetic and nutritional complications, rehospitalization and mortality.
|
From intervention to 12 months
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- APHP251929
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .