Obesity (Disorder)HOVIGAMI-ESGNCT07576777
Hormonal and Microbiota Modulation After Endoscopic Sleeve Gastroplasty
A study testing Laparoscopic sleeve gastrectomy and Endoscopic sleeve gastroplasty in people with Obesity (Disorder) and Metabolic Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity (Disorder), Metabolic Disorders
- What is being tested?
- Laparoscopic sleeve gastrectomy and Endoscopic sleeve gastroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2026to 4 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 17Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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).
Read the detailed description
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.
- Conditions
- Obesity (Disorder), Metabolic Disorders
- Being tested
- Laparoscopic sleeve gastrectomy, Endoscopic sleeve gastroplasty
- Keywords
- Obesity, Endoscopic Sleeve Gastroplasty, Sleeve Gastrectomy, Gastric Emptying, Gut Hormones, Gastric Microbiota, Weight Loss, Metabolic Response
- Medical subject headings
- Obesity, Metabolic Diseases, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic sleeve gastrectomyProcedure or surgery
Participants undergo laparoscopic sleeve gastrectomy with 12-month follow-up including clinical, metabolic, imaging, hormonal and microbiota assessments.
Endoscopic sleeve gastroplastyProcedure or surgery
Participants undergo endoscopic sleeve gastrectomy with 12-month follow-up including clinical, metabolic, imaging, hormonal and microbiota assessments.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic sleeve gastrectomy | Other | Intervention assigned during a multidisciplinary team meeting (MDT). Receives: Procedure: Laparoscopic sleeve gastrectomy |
| Endoscopic sleeve gastroplasty | Other | Intervention assigned during a multidisciplinary team meeting (MDT). Receives: Procedure: Endoscopic sleeve gastroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months post-intervention
Secondary outcomes (13)
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.
Measured: Baseline to 12 months
Total Body Weight Loss (TBWL)
Total Body Weight Loss expressed as percentage (%) of initial body weight.
Measured: Baseline, 1, 3, 6 and 12 months
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.
Measured: Baseline, 1, 3, 6 and 12 months
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.
Measured: Baseline to 12 months
Correlation between gastric emptying and PYY plasma levels
Correlation between gastric emptying assessed by scintigraphy (gastric half-emptying time in minutes) and PYY plasma concentrations measured after a standardized meal test.
Measured: Baseline to 12 months
Correlation between gastric emptying and GIP plasma levels
Correlation between gastric emptying assessed by scintigraphy (gastric half-emptying time in minutes) and GIP plasma concentrations measured after a standardized meal test.
Measured: Baseline to 12 months
Correlation between gastric emptying and ghrelin plasma levels
Correlation between gastric emptying assessed by scintigraphy (gastric half-emptying time in minutes) and ghrelin plasma concentrations measured after a standardized meal test
Measured: Baseline to 12 months
Gastric volume assessed by CT-based volumetry
Measurement of gastric volume using CT scan (gastroscanner) with volumetric reconstruction. Results expressed in milliliters (mL).
Measured: Baseline, 1 month and 12 months
Effect of gastric emptying time on total body weight loss
Total body weight loss (%), analyzed according to gastric half-emptying time (minutes) assessed by gastric scintigraphy using linear regression.
Measured: Baseline to 12 months
Effect of postprandial GLP-1 plasma concentration on total body weight loss
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.
Measured: Baseline to 12 months
Effect of gastric volume on total body weight loss
Total body weight loss (%), analyzed according to gastric volume (mL) measured by computed tomography (CT scan) using linear regression.
Measured: Baseline to 12 months
Effect of gastric microbiota diversity on total body weight loss
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.
Measured: Baseline to 12 months
Safety and tolerability of endosleeve versus surgical sleeve
Incidence of adverse events including digestive, hemorrhagic, infectious, anesthetic and nutritional complications, rehospitalization and mortality.
Measured: From intervention to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start4 May 2026 (estimated)
- Primary completion4 Dec 2028 (estimated)
- Study completion4 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (Disorder)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective comparative study with two groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576777
- Sponsor's protocol ID
- APHP251929
- Acronym
- HOVIGAMI-ESG
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roles of Hormonal Modulation and the Microbiota in Gastric Emptying and Metabolic Response After Endoscopic Sleeve Gastroplasty
- ClinicalTrials.gov ID
- NCT07576777
- Acronym / sponsor ID
- HOVIGAMI-ESG / APHP251929
- Conditions
- Obesity (Disorder), Metabolic Disorders
- Keywords
- Obesity, Endoscopic Sleeve Gastroplasty, Sleeve Gastrectomy, Gastric Emptying, Gut Hormones, Gastric Microbiota, Weight Loss, Metabolic Response
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 May 2026 (estimated)
- Primary completion
- 4 Dec 2028 (estimated)
- Study completion
- 4 May 2029 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective comparative study with two groups
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic sleeve gastrectomy | Other | Procedure: Laparoscopic sleeve gastrectomyIntervention assigned during a multidisciplinary team meeting (MDT). |
| Endoscopic sleeve gastroplasty | Other | Procedure: Endoscopic sleeve gastroplastyIntervention assigned during a multidisciplinary team meeting (MDT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic sleeve gastrectomyParticipants undergo laparoscopic sleeve gastrectomy with 12-month follow-up including clinical, metabolic, imaging, hormonal and microbiota assessments. | Procedure or surgery | Laparoscopic sleeve gastrectomy |
| Endoscopic sleeve gastroplastyParticipants undergo endoscopic sleeve gastrectomy with 12-month follow-up including clinical, metabolic, imaging, hormonal and microbiota assessments. | Procedure or surgery | Endoscopic sleeve gastroplasty |
Primary outcome
Gastric emptying evolution after endoscopic sleeve gastroplasty versus surgical sleeve
Time frame: 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.
13 secondary outcomes
Gastric microbiota diversity assessed by 16S rRNA sequencing
Time frame: Baseline to 12 months
Total Body Weight Loss (TBWL)
Time frame: Baseline, 1, 3, 6 and 12 months
Postprandial GLP-1 plasma concentration after standardized meal test
Time frame: Baseline, 1, 3, 6 and 12 months
Correlation between gastric emptying and GLP-1 plasma levels
Time frame: Baseline to 12 months
Correlation between gastric emptying and PYY plasma levels
Time frame: Baseline to 12 months
Correlation between gastric emptying and GIP plasma levels
Time frame: Baseline to 12 months
Correlation between gastric emptying and ghrelin plasma levels
Time frame: Baseline to 12 months
Gastric volume assessed by CT-based volumetry
Time frame: Baseline, 1 month and 12 months
Effect of gastric emptying time on total body weight loss
Time frame: Baseline to 12 months
Effect of postprandial GLP-1 plasma concentration on total body weight loss
Time frame: Baseline to 12 months
Effect of gastric volume on total body weight loss
Time frame: Baseline to 12 months
Effect of gastric microbiota diversity on total body weight loss
Time frame: Baseline to 12 months
Safety and tolerability of endosleeve versus surgical sleeve
Time frame: From intervention to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic sleeve gastrectomy and Endoscopic sleeve gastroplasty in people with Obesity (Disorder) and Metabolic Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxime AMOYEL, DM (01 40 25 76 52, Maxime.amoyal@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric emptying evolution after endoscopic sleeve gastroplasty versus surgical sleeve (time frame: Baseline to 12 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026; AzTrials last refreshed its copy on 3 Nov 2026.