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Hormonal and Microbiota Modulation After Endoscopic Sleeve Gastroplasty (HOVIGAMI-ESG)

4. maj 2026 opdateret af: Assistance Publique - Hôpitaux de Paris

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).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
    • Paris
      • Paris, Paris, Frankrig, 75018
        • Bichat hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Laparoscopic sleeve gastrectomy
Intervention assigned during a multidisciplinary team meeting (MDT).
Procedure: Laparoscopic sleeve gastrectomy
Participants undergo laparoscopic sleeve gastrectomy with 12-month follow-up including clinical, metabolic, imaging, hormonal and microbiota assessments.
Andet: Endoscopic sleeve gastroplasty
Intervention assigned during a multidisciplinary team meeting (MDT).
Procedure: Endoscopic sleeve gastroplasty
Participants undergo endoscopic sleeve gastrectomy with 12-month follow-up including clinical, metabolic, imaging, hormonal and microbiota assessments.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gastric emptying evolution after endoscopic sleeve gastroplasty versus surgical sleeve
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gastric microbiota diversity assessed by 16S rRNA sequencing
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Assistance Publique - Hôpitaux de Paris

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

4. maj 2026

Primær færdiggørelse (Anslået)

4. december 2028

Studieafslutning (Anslået)

4. maj 2029

Datoer for studieregistrering

Først indsendt

16. april 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

8. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • APHP251929

Plan for individuelle deltagerdata (IPD)

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