ObesityPREDISLEGENCT06153056
Identification of Factors Predictive of the Efficacy of Endoscopic Endoscopic Sleeve Gastroplasty
An observational study of Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Endoscopic sleeve gastroplasty and bypass are currently available for weight loss in obese patients who have failed nutritional management. Despite very low risks, these techniques remain invasive. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Bloed-, ontlasting- en speekselmonsters
- Type of treatment
- Pill or oral medicine
- How many people
- 205 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2025to 2 Feb 2031
- Phase
- Observational
- 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
Study population: Major grade I obese patients (BMI between 30 and 35 kg/m²) not eligible for sleeve gastrectomy
Who may be able to join
- Patient of legal age (Age ≥ 18 years)
- Patient capable of understanding the study and signing a consent.
- BMI between 30 and 35 kg/m² with the presence of at least one one obesity-related complication (diabetes, dyslipidemia, sleep apnea syndrome, non-alcoholic steatohepatitis, joint pain joint pain).
- Patients with a BMI greater than 35 kg/m² who have been bariatric surgery has been refused.
- Patient who has failed to lose weight and improve with conventional techniques.
- Patient affiliated to a social security scheme
Who cannot join
- Patient having taken antibiotics 3 months prior to inclusion.
- Patient under legal protection.
- Patient at risk of gastric cancer requiring regular endoscopic surveillance: extensive intestinal atrophy and/or metaplasia on biopsy.
- Patient with a history of gastrointestinal inflammatory disease of gastric localization, hepatic or renal insufficiency, portal hypertension.
- Patient with evidence of peptic ulcer disease and/or progressive peptic ulcer disease.
- Patient with pathology affecting general health health and/or life expectancy.
- Patient with a history of bariatric surgery.
- Patient on AME
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Antoine Béclère
Paris
Cosmin VOICAN, Doctor, cosmin.voican@aphp.fr
About this study
Official title: Identification of Factors Predictive of the Efficacy of Endoscopic Endoscopic Sleeve Gastroplasty & Study the Evolution of Clinical, Biological and Intestinal Intestinal Microbiota After Surgery
Endoscopic sleeve gastroplasty and bypass are currently available for weight loss in obese patients who have failed nutritional management. Despite very low risks, these techniques remain invasive. What's more, the French National Authority for Health recommends this procedure for patients with a BMI above 35 kg/m² with associated co-morbidities, or above 40 kg/m². This excludes grade I obese patients (30 < BMI < 35) who have no effective means of losing weight. The hospital's hepato-gastroenterology and nutrition department has therefore implemented endoscopic sleeve gastroplasty to address this problem. As with other surgical techniques, there is heterogeneity heterogeneity in weight loss. The investigators therefore aim to identify factors predictive of the efficacy of this procedure in order to improve patient management of patients.
Read the detailed description
The prevalence of obesity is increasing worldwide, and it is estimated that one quarter of the world's population will be overweight or obese by 2045. Obesity can lead to complications, including cardiovascular damage (myocardial ischemia and stroke), liver damage (non-alcoholic steatohepatitis and liver cancer), diabetes and extra-hepatic cancers. In this context, achievement of a significant long-term weight loss is of paramount importance to ameliorate patient outcome. Bariatric surgery is the most effective treatment for severe obesity and results in a significant long-term weight loss. However, bariatric surgery is restricted to patients with a BMI >40 kg/m2 or >35 kg/m2 with commodities (hypertension, diabetes, sleep apnoea, NASH). Therefore, the majority of obese patients do not benefit from this procedure. Recent advances in flexible endoluminal endoscopy now provide the tools for transoral endoscopic gastric volume reduction (ESG, endoscopic sleeve gastroplasty).
The gastric body is reduced by an endoscopic procedure involving suture plications. This minimally invasive method may be a good therapeutic option to obtain a significant weight reduction in patients with moderate obesity or those with severe obesity and no indication for bariatric surgery (BMI between 35 and 40 kg/m2 without commodities). In this context this study aims to identify predictive factors of weight loss following ESG and explore changes of metabolic parameters, metabolomic profiles and gut microbiota profiles. This is a retro-prospective cohort study including patients with moderate obesity undergoing ECG between March 2017 and September 2023. Clinical parameters (weight, high, BMI, weight fluctuations), serum metabolic parameters (standard lipid profile, lipoprotein levels, fasting plasma glucose, insulin levels, C-peptide levels, hemoglobin A1c) and liver function test parameters (standard biology, transient elastometry, Fibrotest®, Actitest®, abdominal ultrasound) are systematically collected for all patients before ESG and then at three- and twelve-month post-ESG. Samples of serum, plasma, stools and saliva are also systematically collected for research purpose before ESG and then at three- and twelve-month post-ESG. Each sample is stored at -80°C for subsequent analysis. Metabolomic/lipidomic analysis will be used to quantify metabolite and lipid species in serum/plasma samples. Metagenomic analysis will be used to characterise faecal and salivary microbiota profiles.
- Conditions
- Obesity
- Being tested
- Bloed-, ontlasting- en speekselmonsters
- Keywords
- Obesity, Endoscopic sleeve gastroplasty, Weight loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bloed-, ontlasting- en speekselmonstersDiagnostic test
In addition, the blood collected (24 mL) will be used for the following analyses:
GLP-1, PYY, branched-chain amino acids, Adipokines, leptin, adiponectin Blood bile acid levels: total and detailed analyzed by HPLC MS/MS Serum microbiome profile Genome-wide association study.
The stool sample will be used to establish the :
Intestinal bile acid profile Intestinal microbiota profile Saliva sampling for oral microbiota profiling.
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum metabolite profile using widely targeted metabolomics according to weigh loss amount (less than 10% of total weight versus more than 10% of total weight loss at 12 months post-surgery)
A volume of 50 µl of serum/plasma will be used for analysis of serum metabolites using widely targeted metabolomics mass spectrometry.
Measured: Before endoscopic sleeve gastroplasty
Secondary outcomes (14)
Clinical parameters at baseline and then at 3 and 12 month post-intervention.
Weight expressed in kg, percentage of total weight loss and percentage of excessed weight loss will be analysed as they are systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Basic serum lipid profile at baseline and then at 3 and 12 month post-intervention.
Basic serum lipid profile will be analysed by spectrometry as they are systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Glycated hemoglobin at baseline and then at 3 and 12 month post-intervention.
Glycated hemoglobin expressed in % will be analysed as they are systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Insulin at baseline and then at 3 and 12 month post-intervention.
Insulin expressed in mUI/l will be analysed as it is systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
C peptide at baseline and then at 3 and 12 month post-intervention.
C peptide expressed in µg/l will be analysed as it is systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Ferritin at baseline and then at 3 and 12 month post-intervention.
Ferritin expressed in µg/l will be analysed as it is systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver function test parameter Alanine transaminase (ALT) at baseline and then at 3 and 12 month post-intervention.
ALT levels expressed in IU/l will be analysed as they are systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver function test parameter aspartate transaminase (AST) at baseline and then at 3 and 12 month post-intervention.
AST levels expressed in IU/l will be analysed as they are systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver function test parameter Gamma-glutamyltransferase (GGT) at baseline and then at 3 and 12 month post-intervention.
GGT levels expressed in IU/l will be analysed as they are systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver function test parameter Alkaline phosphatase (ALP) at baseline and then at 3 and 12 month post-intervention.
ALP levels expressed in IU/l will be analysed as they are systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver fibrosis assessed by transient elastometry at baseline and then at 3 and 12 month post-intervention
Transient elastometry expressed in kPa will be analysed as they are systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver steatosis assessed by controlled attenuation parameter (CAP) at baseline and then at 3 and 12 month post-intervention.
Controlled attenuation parameter expressed in dB/m will be analysed as they are systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Serum metabolites using widely targeted metabolomics at baseline and then at 3 and 12 month post-intervention.
A volume of 50 µl of serum/plasma will be used for analysis of serum metabolites using widely targeted metabolomics by mass spectrometry
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Complications of endoscopic sleeve gastroplasty
Data on the potential complications (occurrence of perforation, bleeding, peritonitis and other infections, thrombo-embolic events and death) of endoscopic sleeve gastroplasty will be collected.
Measured: During the first week post-endoscopic sleeve gastroplasty and at Month 3 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start9 Sep 2025
- Primary completion2 Feb 2031 (estimated)
- Study completion2 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cosmin VOICAN, MD, PhD, Principal investigator, APHP, Antoine-Béclère Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153056
- Sponsor's protocol ID
- APHP230882
- Other IDs
- 2023-A01226-39
- Acronym
- PREDISLEGE
- Status last verified
- Jan 2026
- First submitted
- 22 Nov 2023
- Last updated
- 21 Jan 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Factors Predictive of the Efficacy of Endoscopic Endoscopic Sleeve Gastroplasty & Study the Evolution of Clinical, Biological and Intestinal Intestinal Microbiota After Surgery
- ClinicalTrials.gov ID
- NCT06153056
- Acronym / sponsor ID
- PREDISLEGE / APHP230882
- Conditions
- Obesity
- Keywords
- Obesity, Endoscopic sleeve gastroplasty, Weight loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 2 Feb 2031 (estimated)
- Study completion
- 2 Feb 2031 (estimated)
- First posted
- 1 Dec 2023 (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.
Endoscopic sleeve gastroplasty and bypass are currently available for weight loss in obese patients who have failed nutritional management. Despite very low risks, these techniques remain invasive. What's more, the French National Authority for Health recommends this procedure for patients with a BMI above 35 kg/m² with associated co-morbidities, or above 40 kg/m². This excludes grade I obese patients (30 < BMI < 35) who have no effective means of losing weight. The hospital's hepato-gastroenterology and nutrition department has therefore implemented endoscopic sleeve gastroplasty to address this problem. As with other surgical techniques, there is heterogeneity heterogeneity in weight loss. The investigators therefore aim to identify factors predictive of the efficacy of this procedure in order to improve patient management of patients.
Detailed description
The prevalence of obesity is increasing worldwide, and it is estimated that one quarter of the world's population will be overweight or obese by 2045. Obesity can lead to complications, including cardiovascular damage (myocardial ischemia and stroke), liver damage (non-alcoholic steatohepatitis and liver cancer), diabetes and extra-hepatic cancers. In this context, achievement of a significant long-term weight loss is of paramount importance to ameliorate patient outcome. Bariatric surgery is the most effective treatment for severe obesity and results in a significant long-term weight loss. However, bariatric surgery is restricted to patients with a BMI >40 kg/m2 or >35 kg/m2 with commodities (hypertension, diabetes, sleep apnoea, NASH). Therefore, the majority of obese patients do not benefit from this procedure. Recent advances in flexible endoluminal endoscopy now provide the tools for transoral endoscopic gastric volume reduction (ESG, endoscopic sleeve gastroplasty).
The gastric body is reduced by an endoscopic procedure involving suture plications. This minimally invasive method may be a good therapeutic option to obtain a significant weight reduction in patients with moderate obesity or those with severe obesity and no indication for bariatric surgery (BMI between 35 and 40 kg/m2 without commodities). In this context this study aims to identify predictive factors of weight loss following ESG and explore changes of metabolic parameters, metabolomic profiles and gut microbiota profiles. This is a retro-prospective cohort study including patients with moderate obesity undergoing ECG between March 2017 and September 2023. Clinical parameters (weight, high, BMI, weight fluctuations), serum metabolic parameters (standard lipid profile, lipoprotein levels, fasting plasma glucose, insulin levels, C-peptide levels, hemoglobin A1c) and liver function test parameters (standard biology, transient elastometry, Fibrotest®, Actitest®, abdominal ultrasound) are systematically collected for all patients before ESG and then at three- and twelve-month post-ESG. Samples of serum, plasma, stools and saliva are also systematically collected for research purpose before ESG and then at three- and twelve-month post-ESG. Each sample is stored at -80°C for subsequent analysis. Metabolomic/lipidomic analysis will be used to quantify metabolite and lipid species in serum/plasma samples. Metagenomic analysis will be used to characterise faecal and salivary microbiota profiles.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major grade I obese patients (BMI between 30 and 35 kg/m²) not eligible for sleeve gastrectomy
Key inclusion criteria (6 listed)
- Patient of legal age (Age ≥ 18 years)
- Patient capable of understanding the study and signing a consent.
- BMI between 30 and 35 kg/m² with the presence of at least one one obesity-related complication (diabetes, dyslipidemia, sleep apnea syndrome, non-alcoholic steatohepatitis, joint pain joint pain).
- Patients with a BMI greater than 35 kg/m² who have been bariatric surgery has been refused.
- Patient who has failed to lose weight and improve with conventional techniques.
Key exclusion criteria (8 listed)
- Patient having taken antibiotics 3 months prior to inclusion.
- Patient under legal protection.
- Patient at risk of gastric cancer requiring regular endoscopic surveillance: extensive intestinal atrophy and/or metaplasia on biopsy.
- Patient with a history of gastrointestinal inflammatory disease of gastric localization, hepatic or renal insufficiency, portal hypertension.
- Patient with evidence of peptic ulcer disease and/or progressive peptic ulcer disease.
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 |
|---|---|---|
| Bloed-, ontlasting- en speekselmonstersIn addition, the blood collected (24 mL) will be used for the following analyses: GLP-1, PYY, branched-chain amino acids, Adipokines, leptin, adiponectin Blood bile acid levels: total and detailed analyzed by HPLC MS/MS Serum microbiome profile Genome-wide association study. The stool sample will be used to establish the : Intestinal bile acid profile Intestinal microbiota profile Saliva sampling for oral microbiota profiling. | Diagnostic test | – |
Primary outcome
Serum metabolite profile using widely targeted metabolomics according to weigh loss amount (less than 10% of total weight versus more than 10% of total weight loss at 12 months post-surgery)
Time frame: Before endoscopic sleeve gastroplasty
A volume of 50 µl of serum/plasma will be used for analysis of serum metabolites using widely targeted metabolomics mass spectrometry.
14 secondary outcomes
Clinical parameters at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Basic serum lipid profile at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Glycated hemoglobin at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Insulin at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
C peptide at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Ferritin at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver function test parameter Alanine transaminase (ALT) at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver function test parameter aspartate transaminase (AST) at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver function test parameter Gamma-glutamyltransferase (GGT) at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver function test parameter Alkaline phosphatase (ALP) at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver fibrosis assessed by transient elastometry at baseline and then at 3 and 12 month post-intervention
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver steatosis assessed by controlled attenuation parameter (CAP) at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Serum metabolites using widely targeted metabolomics at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Complications of endoscopic sleeve gastroplasty
Time frame: During the first week post-endoscopic sleeve gastroplasty and at Month 3 and Month 12
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 21 Jan 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.
Cosmin VOICAN, MD, PhD principal investigator
APHP, Antoine-Béclère Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 21 Jan 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 Cosmin VOICAN, MD, PhD (1 45 37 47 75 ext. +33, cosmin.voican@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum metabolite profile using widely targeted metabolomics according to weigh loss amount (less than 10% of total weight versus more than 10% of total weight loss at 12 months post-surgery) (time frame: Before endoscopic sleeve gastroplasty). 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 21 Jan 2026.